Ignite Creation Date:
2025-12-24 @ 10:53 PM
Ignite Modification Date:
2025-12-25 @ 8:21 PM
Study NCT ID:
NCT04963569
Status:
COMPLETED
Last Update Posted:
2025-04-15
First Post:
2021-06-10
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Mechanistic Inflammatory Sub-study Embedded Within the Albumin vs Balanced Crystalloid Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'j.cafferkey@ed.ac.uk', 'phone': '0', 'title': 'Dr John (Jack) Cafferkey', 'organization': 'NHS Lothian/University of Edinburgh'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events recorded for this study up to 24 hours from presentation', 'description': "This study collected adverse event data related to this study alone (and its procedures, i.e. venepuncture).\n\nThe report of mortality is a reflection of the patient's clinical course and was deemed of no relation to study interventions (i.e. venepuncture).\n\nThe main, linked, cited study (ABC Sepsis) collected and describes adverse events relevant to the main study and its interventions.", 'eventGroups': [{'id': 'EG000', 'title': 'Albumin', 'description': 'Participants enrolled in the ABC Sepsis trial who have been randomised to 5% Human Albumin Solution as the sole resuscitative fluid in the first 6 hours.', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 0, 'seriousNumAtRisk': 14, 'deathsNumAffected': 1, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Balanced Crystalloid', 'description': 'Participants enrolled in the ABC Sepsis trial who have been randomised to Balanced Crystalloid as the sole resuscitative fluid in the first 6 hours.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Albumin', 'description': '5% HAS'}, {'id': 'OG001', 'title': 'Crystalloid', 'description': 'Balanced crystalloid'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At presentation, 12 and 24 hours.', 'description': 'Exploratory analysis to map mechanistic inflammatory response over time: 0, 12 and 24 hours. As the analysis is exploratory, there is no defined limit to cell types or cytokines measured.\n\nCytokines measured: tumour necrosis factor alpha (TNF-alpha), interleukin 6 (IL-6), granulocyte-macrophage colony-stimulating factor (GM-CSF), C-X-C motif chemokine ligand 10 (CXCL10), interleukin 5 (IL-5), interferon alpha 2 (IFN-a2), interleukin 4 (IL-4), C-C motif chemokine ligand 3 (CCL3), interleukin 10 (IL-10), interleukin 12p70 (IL-12p70), C-C motif chemokine ligand 20 (CCL20), interferon gamma (IFN-gamma), C-X-C motif chemokine ligand 8 (CXCL8), and C-C motif chemokine 4(CCL4).\n\nThis outcome measure describes the number of participants who were eligible for inclusion in the exploratory analysis described above and in later outcomes.\n\nUnits: number of participants eligible for inclusion in comparison.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Non-numerical outcome; all participants included in analysis.'}, {'type': 'PRIMARY', 'title': 'Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. TNF-alpha at Presentation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Albumin', 'description': '5% HAS'}, {'id': 'OG001', 'title': 'Crystalloid', 'description': 'Balanced crystalloid'}], 'classes': [{'categories': [{'measurements': [{'value': '18.3', 'spread': '18.9', 'groupId': 'OG000'}, {'value': '8.7', 'spread': '14.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 hours from presentation', 'description': 'Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at presentation.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. TNF-alpha at 12 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Albumin', 'description': '5% HAS'}, {'id': 'OG001', 'title': 'Crystalloid', 'description': 'Balanced crystalloid'}], 'classes': [{'categories': [{'measurements': [{'value': '15.4', 'spread': '14.0', 'groupId': 'OG000'}, {'value': '6.6', 'spread': '6.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 hours from presentation', 'description': 'Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at 12 hours.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. TNF-alpha at 24 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Albumin', 'description': '5% HAS'}, {'id': 'OG001', 'title': 'Crystalloid', 'description': 'Balanced crystalloid'}], 'classes': [{'categories': [{'measurements': [{'value': '16.5', 'spread': '14.2', 'groupId': 'OG000'}, {'value': '7.3', 'spread': '10.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 hours from presentation', 'description': 'Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at 24 hours.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. GM-CSF at Presentation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Albumin', 'description': '5% HAS'}, {'id': 'OG001', 'title': 'Crystalloid', 'description': 'Balanced crystalloid'}], 'classes': [{'categories': [{'measurements': [{'value': '9.9', 'spread': '10.6', 'groupId': 'OG000'}, {'value': '4.5', 'spread': '7.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 hours', 'description': 'Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at presentation.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. GM-CSF at 12 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Albumin', 'description': '5% HAS'}, {'id': 'OG001', 'title': 'Crystalloid', 'description': 'Balanced crystalloid'}], 'classes': [{'categories': [{'measurements': [{'value': '7.2', 'spread': '8.2', 'groupId': 'OG000'}, {'value': '2.8', 'spread': '4.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 hours from presentation', 'description': 'Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at 12 hours.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. GM-CSF at 24 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Albumin', 'description': '5% HAS'}, {'id': 'OG001', 'title': 'Crystalloid', 'description': 'Balanced crystalloid'}], 'classes': [{'categories': [{'measurements': [{'value': '7.7', 'spread': '9.5', 'groupId': 'OG000'}, {'value': '3.1', 'spread': '4.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 hours from presentation', 'description': 'Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at 24 hours.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. IL-6 at 0 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Albumin', 'description': '5% HAS'}, {'id': 'OG001', 'title': 'Crystalloid', 'description': 'Balanced crystalloid'}], 'classes': [{'categories': [{'measurements': [{'value': '2017.9', 'spread': '5436.7', 'groupId': 'OG000'}, {'value': '2513.3', 'spread': '6423.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 hours from presentation', 'description': 'Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at presentation.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. IL-6 at 12 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Albumin', 'description': '5% HAS'}, {'id': 'OG001', 'title': 'Crystalloid', 'description': 'Balanced crystalloid'}], 'classes': [{'categories': [{'measurements': [{'value': '492.0', 'spread': '1557.3', 'groupId': 'OG000'}, {'value': '305.6', 'spread': '764.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 hours from presentation', 'description': 'Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at 12 hours.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. IL-6 at 24 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Albumin', 'description': '5% HAS'}, {'id': 'OG001', 'title': 'Crystalloid', 'description': 'Balanced crystalloid'}], 'classes': [{'categories': [{'measurements': [{'value': '119.0', 'spread': '247.0', 'groupId': 'OG000'}, {'value': '52.3', 'spread': '72.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 hours from presentation', 'description': 'Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at 24 hours.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. CXCL10 at 0 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Albumin', 'description': '5% HAS'}, {'id': 'OG001', 'title': 'Crystalloid', 'description': 'Balanced crystalloid'}], 'classes': [{'categories': [{'measurements': [{'value': '453.1', 'spread': '496.0', 'groupId': 'OG000'}, {'value': '1073.3', 'spread': '2240.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 hours from presentation', 'description': 'Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at presentation.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. CXCL10 at 12 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Albumin', 'description': '5% HAS'}, {'id': 'OG001', 'title': 'Crystalloid', 'description': 'Balanced crystalloid'}], 'classes': [{'categories': [{'measurements': [{'value': '816.6', 'spread': '1243.1', 'groupId': 'OG000'}, {'value': '846.1', 'spread': '1534.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 hours from presentation', 'description': 'Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at 12 hours.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. CXCL10 at 24 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Albumin', 'description': '5% HAS'}, {'id': 'OG001', 'title': 'Crystalloid', 'description': 'Balanced crystalloid'}], 'classes': [{'categories': [{'measurements': [{'value': '450.7', 'spread': '626.2', 'groupId': 'OG000'}, {'value': '324.4', 'spread': '369.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 hours from presentation.', 'description': 'Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at 24 hours.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. Il-5 at 0 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Albumin', 'description': '5% HAS'}, {'id': 'OG001', 'title': 'Crystalloid', 'description': 'Balanced crystalloid'}], 'classes': [{'categories': [{'measurements': [{'value': '5.8', 'spread': '5.6', 'groupId': 'OG000'}, {'value': '15.6', 'spread': '44.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 hours from presentation', 'description': 'Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at presentation.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. Il-5 at 12 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Albumin', 'description': '5% HAS'}, {'id': 'OG001', 'title': 'Crystalloid', 'description': 'Balanced crystalloid'}], 'classes': [{'categories': [{'measurements': [{'value': '4.9', 'spread': '4.4', 'groupId': 'OG000'}, {'value': '18.4', 'spread': '55.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 hours from presentation', 'description': 'Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at 12 hours.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. Il-5 at 24 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Albumin', 'description': '5% HAS'}, {'id': 'OG001', 'title': 'Crystalloid', 'description': 'Balanced crystalloid'}], 'classes': [{'categories': [{'measurements': [{'value': '5.0', 'spread': '4.6', 'groupId': 'OG000'}, {'value': '2.4', 'spread': '3.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 hours from presentation', 'description': 'Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at 24 hours.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. IFN-a2 at 0 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Albumin', 'description': '5% HAS'}, {'id': 'OG001', 'title': 'Crystalloid', 'description': 'Balanced crystalloid'}], 'classes': [{'categories': [{'measurements': [{'value': '16.6', 'spread': '27.7', 'groupId': 'OG000'}, {'value': '5.6', 'spread': '5.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 hours from presentation', 'description': 'Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at presentation.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. IFN-a2 at 12 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Albumin', 'description': '5% HAS'}, {'id': 'OG001', 'title': 'Crystalloid', 'description': 'Balanced crystalloid'}], 'classes': [{'categories': [{'measurements': [{'value': '12.3', 'spread': '18.5', 'groupId': 'OG000'}, {'value': '4.2', 'spread': '2.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 hours from presentation', 'description': 'Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at 12 hours.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. IFN-a2 at 24 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Albumin', 'description': '5% HAS'}, {'id': 'OG001', 'title': 'Crystalloid', 'description': 'Balanced crystalloid'}], 'classes': [{'categories': [{'measurements': [{'value': '11.0', 'spread': '9.9', 'groupId': 'OG000'}, {'value': '4.0', 'spread': '3.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 hours from presentation', 'description': 'Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at 24 hours.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. IL-4 at 0 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Albumin', 'description': '5% HAS'}, {'id': 'OG001', 'title': 'Crystalloid', 'description': 'Balanced crystalloid'}], 'classes': [{'categories': [{'measurements': [{'value': '19.5', 'spread': '22.1', 'groupId': 'OG000'}, {'value': '9.0', 'spread': '12.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 hours from presentation', 'description': 'Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at presentation.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. IL-4 at 12 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Albumin', 'description': '5% HAS'}, {'id': 'OG001', 'title': 'Crystalloid', 'description': 'Balanced crystalloid'}], 'classes': [{'categories': [{'measurements': [{'value': '14.6', 'spread': '15.2', 'groupId': 'OG000'}, {'value': '5.5', 'spread': '5.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 hours from presentation', 'description': 'Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at 12 hours.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. IL-4 at 24 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Albumin', 'description': '5% HAS'}, {'id': 'OG001', 'title': 'Crystalloid', 'description': 'Balanced crystalloid'}], 'classes': [{'categories': [{'measurements': [{'value': '14.4', 'spread': '21.3', 'groupId': 'OG000'}, {'value': '7.1', 'spread': '10.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 hours from presentation', 'description': 'Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at presentation.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. CCL3 at 0 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Albumin', 'description': '5% HAS'}, {'id': 'OG001', 'title': 'Crystalloid', 'description': 'Balanced crystalloid'}], 'classes': [{'categories': [{'measurements': [{'value': '127.2', 'spread': '176.9', 'groupId': 'OG000'}, {'value': '55.5', 'spread': '55.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 hours from presentation', 'description': 'Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at presentation.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. CCL3 at 12 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Albumin', 'description': '5% HAS'}, {'id': 'OG001', 'title': 'Crystalloid', 'description': 'Balanced crystalloid'}], 'classes': [{'categories': [{'measurements': [{'value': '95.7', 'spread': '128.7', 'groupId': 'OG000'}, {'value': '48.5', 'spread': '63.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 hours from presentation', 'description': 'Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at 12 hours from presentation.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. 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As the analysis is exploratory, there is no defined limit to cell types or cytokines measured.\n\nCytokines measured: tumour necrosis factor alpha (TNF-alpha), interleukin 6 (IL-6), granulocyte-macrophage colony-stimulating factor (GM-CSF), C-X-C motif chemokine ligand 10 (CXCL10), interleukin 5 (IL-5), interferon alpha 2 (IFN-a2), interleukin 4 (IL-4), C-C motif chemokine ligand 3 (CCL3), interleukin 10 (IL-10), interleukin 12p70 (IL-12p70), C-C motif chemokine ligand 20 (CCL20), interferon gamma (IFN-gamma), C-X-C motif chemokine ligand 8 (CXCL8), and C-C motif chemokine 4(CCL4).\n\nThis outcome measure describes the number of participants who were eligible for inclusion in the exploratory analysis described above and in later outcomes.\n\nUnits: number of participants eligible for inclusion in comparison.'}, {'measure': 'Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. TNF-alpha at Presentation', 'timeFrame': '0 hours from presentation', 'description': 'Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at presentation.'}, {'measure': 'Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. TNF-alpha at 12 Hours', 'timeFrame': '12 hours from presentation', 'description': 'Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at 12 hours.'}, {'measure': 'Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. TNF-alpha at 24 Hours', 'timeFrame': '24 hours from presentation', 'description': 'Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at 24 hours.'}, {'measure': 'Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. GM-CSF at Presentation', 'timeFrame': '0 hours', 'description': 'Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at presentation.'}, {'measure': 'Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. GM-CSF at 12 Hours', 'timeFrame': '12 hours from presentation', 'description': 'Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at 12 hours.'}, {'measure': 'Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. GM-CSF at 24 Hours', 'timeFrame': '24 hours from presentation', 'description': 'Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at 24 hours.'}, {'measure': 'Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. IL-6 at 0 Hours', 'timeFrame': '0 hours from presentation', 'description': 'Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at presentation.'}, {'measure': 'Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. IL-6 at 12 Hours', 'timeFrame': '12 hours from presentation', 'description': 'Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at 12 hours.'}, {'measure': 'Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. IL-6 at 24 Hours', 'timeFrame': '24 hours from presentation', 'description': 'Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at 24 hours.'}, {'measure': 'Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. CXCL10 at 0 Hours', 'timeFrame': '0 hours from presentation', 'description': 'Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at presentation.'}, {'measure': 'Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. CXCL10 at 12 Hours', 'timeFrame': '12 hours from presentation', 'description': 'Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at 12 hours.'}, {'measure': 'Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. CXCL10 at 24 Hours', 'timeFrame': '24 hours from presentation.', 'description': 'Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at 24 hours.'}, {'measure': 'Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. Il-5 at 0 Hours', 'timeFrame': '0 hours from presentation', 'description': 'Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at presentation.'}, {'measure': 'Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. Il-5 at 12 Hours', 'timeFrame': '12 hours from presentation', 'description': 'Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at 12 hours.'}, {'measure': 'Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. Il-5 at 24 Hours', 'timeFrame': '24 hours from presentation', 'description': 'Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at 24 hours.'}, {'measure': 'Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. IFN-a2 at 0 Hours', 'timeFrame': '0 hours from presentation', 'description': 'Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at presentation.'}, {'measure': 'Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. IFN-a2 at 12 Hours', 'timeFrame': '12 hours from presentation', 'description': 'Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at 12 hours.'}, {'measure': 'Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. IFN-a2 at 24 Hours', 'timeFrame': '24 hours from presentation', 'description': 'Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at 24 hours.'}, {'measure': 'Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. IL-4 at 0 Hours', 'timeFrame': '0 hours from presentation', 'description': 'Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at presentation.'}, {'measure': 'Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. IL-4 at 12 Hours', 'timeFrame': '12 hours from presentation', 'description': 'Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at 12 hours.'}, {'measure': 'Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. IL-4 at 24 Hours', 'timeFrame': '24 hours from presentation', 'description': 'Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at presentation.'}, {'measure': 'Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. CCL3 at 0 Hours', 'timeFrame': '0 hours from presentation', 'description': 'Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at presentation.'}, {'measure': 'Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. CCL3 at 12 Hours', 'timeFrame': '12 hours from presentation', 'description': 'Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at 12 hours from presentation.'}, {'measure': 'Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. CCL3 at 24 Hours', 'timeFrame': '24 hours from presentation', 'description': 'Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at 24 hours.'}, {'measure': 'Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. IL-10 at 0 Hours', 'timeFrame': '0 hours from presentation', 'description': 'Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at presentation.'}, {'measure': 'Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. IL-10 at 12 Hours', 'timeFrame': '12 hours from presentation', 'description': 'Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at 12 hours.'}, {'measure': 'Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. IL-10 at 24 Hours', 'timeFrame': '24 hours from presentation', 'description': 'Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at 24 hours.'}, {'measure': 'Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. IL-12p70 at 0 Hours', 'timeFrame': '0 hours from presentation', 'description': 'Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at presentation.'}, {'measure': 'Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. IL-12p70 at 12 Hours', 'timeFrame': '12 hours from presentation', 'description': 'Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at 12 hours.'}, {'measure': 'Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. IL-12p70 at 24 Hours', 'timeFrame': '24 hours from baseline', 'description': 'Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at 24 hours.'}, {'measure': 'Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. CCL20 at 0 Hours', 'timeFrame': '0 hours from baseline', 'description': 'Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at presentation.'}, {'measure': 'Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. CCL20 at 12 Hours', 'timeFrame': '12 hours from presentation', 'description': 'Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at presentation.'}, {'measure': 'Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. CCL20 at 24 Hours', 'timeFrame': '24 hours from presentation', 'description': 'Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at 24 hours.'}, {'measure': 'Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. IFN-gamma at Presentation', 'timeFrame': '0 hours from presentation', 'description': 'Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at presentation.'}, {'measure': 'Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. IFN-gamma at 0 Hours', 'timeFrame': '12 hours from presentation', 'description': 'Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at 12 hours.'}, {'measure': 'Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. IFN-gamma at 24 Hours', 'timeFrame': '24 hours from presentation', 'description': 'Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at 24 hours'}, {'measure': 'Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. CXCL8 at 0 Hours', 'timeFrame': '0 hours from presentation', 'description': 'Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at presentation.'}, {'measure': 'Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. CXCL8 at 12 Hours', 'timeFrame': '12 hours from presentation', 'description': 'Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at 12 hours.'}, {'measure': 'Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. CXCL8 at 24 Hours', 'timeFrame': '24 hours from baseline', 'description': 'Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at presentation.'}, {'measure': 'Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. CCL4 at 0 Hours', 'timeFrame': '0 hours from presentation', 'description': 'Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at presentation.'}, {'measure': 'Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. CCL4 at 12 Hours', 'timeFrame': '12 hours from presentation', 'description': 'Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at presentation.'}, {'measure': 'Longitudinal Change Over Time in Cell Types and Pro and Anti Inflammatory Cytokines in Sepsis. CCL4 at 24 Hours', 'timeFrame': '24 hours from presentation', 'description': 'Exploratory analysis to map mechanistic inflammatory response. Comparison of mean cytokine concentrations between allocation arms. Comparing at 24 hours.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sepsis', 'infection', 'inflammation', 'cytokine', 'interleukin', 'intravenous', 'fluids', 'resuscitation', 'albumin', 'crystalloid'], 'conditions': ['Sepsis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.clinicaltrials.gov/ct2/show/NCT04540094', 'label': 'ABC Sepsis Trial Registration'}, {'url': 'https://www.emergeresearch.org/trial/mis-abc-sepsis/', 'label': 'Study Webpage'}]}, 'descriptionModule': {'briefSummary': 'MIS-ABC Sepsis is a sub-study looking to understand how the immune response in patients with infection changes during the early stages of the illness, as well as after intravenous fluid treatment. Participants in the main trial will be given one of two types of fluid (Human Albumin Solution (HAS) and Balanced Crystalloid) via a drip when they present to the hospital with severe infection (sepsis). The main trial is assessing which fluid is better, and we are going to take three blood samples around the time people come to hospital to see what happens to their immune system as a result of the infection and fluid treatment. We hope our findings will explain why one fluid might be better than another. It may also give us an important information about whether we can predict which people might get sicker despite treatment.', 'detailedDescription': "MIS-ABC Sepsis is linked to the ABC-Sepsis trial, a pilot feasibility trial recruiting patients with community acquired infection/sepsis with a NEWS2 score of five or more and randomising the participants to receiving either balanced crystalloid or 5% HAS as the intravenous resuscitation fluid up to six hours after randomisation.\n\nMIS-ABC Sepsis will take serial blood samples from a small number of these participants, at hospital presentation and at two further points early during the patient's admission, to allow analysis of how inflammation changes during their course of illness. Investigating temporal change and differences between treatment arms of the main study will allow a nuanced analysis of the interplay between severity of illness, physiological changes over time and any potential differences between fluid treatment arm.\n\nThis is a prospective observational study enrolling patients randomised to the ABC Sepsis study. Centres for this trial will be selected from UK NHS hospitals who are recruiting to the main ABC Sepsis study. Participants will be recruited as soon as possible, and up to 12 hours after presentation to the Emergency Department, Surgical Assessment Unit or Medical Admissions Unit.\n\nThe treatment phase of the main study spans 6 hours following randomisation, with the follow up period extending to 90 days. This sub-study requires three blood samples: immediately after enrolment, at approximately 12 and 24 hours thereafter. The follow up period similarly extends to 90 days, using routine data from the medical records for follow up."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Individuals presenting to the Emergency Department, Acute Medical Unit or Surgical Admission Unit.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Able to obtain informed consent\n* Eligible for and randomised into the ABC Sepsis trial\n\nExclusion Criteria:\n\n* Excluded from the ABC Sepsis trial'}, 'identificationModule': {'nctId': 'NCT04963569', 'acronym': 'MIS-ABC Sepsis', 'briefTitle': 'Mechanistic Inflammatory Sub-study Embedded Within the Albumin vs Balanced Crystalloid Trial', 'organization': {'class': 'OTHER', 'fullName': 'University of Edinburgh'}, 'officialTitle': 'Mechanistic Inflammatory Sub-study Embedded Within the Albumin vs Balanced Crystalloid Trial', 'orgStudyIdInfo': {'id': 'AC21050'}, 'secondaryIdInfos': [{'id': 'G/2021/1', 'type': 'OTHER_GRANT', 'domain': 'Royal College of Emergency Medicine'}, {'id': '301333', 'type': 'OTHER', 'domain': 'IRAS (England)'}, {'id': '300332', 'type': 'OTHER', 'domain': 'IRAS (Scotland)'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Albumin', 'description': 'Participants enrolled in the ABC Sepsis trial who have been randomised to 5% Human Albumin Solution as the sole resuscitative fluid in the first 6 hours.'}, {'label': 'Balanced Crystalloid', 'description': 'Participants enrolled in the ABC Sepsis trial who have been randomised to Balanced Crystalloid as the sole resuscitative fluid in the first 6 hours.'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'EH16 4SA', 'city': 'Edinburgh', 'state': 'Midlothian', 'country': 'United Kingdom', 'facility': 'Royal Infirmary of Edinburgh', 'geoPoint': {'lat': 55.95206, 'lon': -3.19648}}], 'overallOfficials': [{'name': 'Alasdair Gray, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Edinburgh'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'We plan to share study day according to the FAIR principles, after agreement with the study sponsor policies.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Edinburgh', 'class': 'OTHER'}, 'collaborators': [{'name': 'NHS Lothian', 'class': 'OTHER_GOV'}, {'name': 'Royal College of Emergency Medicine', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}