Ignite Creation Date:
2025-12-24 @ 11:18 PM
Ignite Modification Date:
2025-12-25 @ 8:58 PM
Study NCT ID:
NCT05094856
Status:
COMPLETED
Last Update Posted:
2024-06-07
First Post:
2021-07-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Fluid Therapy on Peripheral TIssse Perfusion During Sepsis/Septic Shock
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012772', 'term': 'Shock, Septic'}, {'id': 'D018805', 'term': 'Sepsis'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012769', 'term': 'Shock'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 61}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-02-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2023-03-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-06', 'studyFirstSubmitDate': '2021-07-31', 'studyFirstSubmitQcDate': '2021-10-22', 'lastUpdatePostDateStruct': {'date': '2024-06-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Compare the effect of volume expansion by saline versus albumin on the correction of peripheral tissue hypoperfusion by measuring Index skin recoloration time (CRT) at H0 and H1', 'timeFrame': '1 hour', 'description': 'Proportion of patients who normalized their cutaneous re-coloring time (CRT) measured at the index level, defined by a value \\<3 seconds at H1. The clinical measurement method has been standardized in the participating departments and has been used for several years in clinical practice.'}], 'secondaryOutcomes': [{'measure': 'CRT Measure', 'timeFrame': '4 hours', 'description': 'Clinical tissue perfusion parameters will be measured clinically every 30 minutes, as usual in patients with septis/septic shock.'}, {'measure': 'mottling score measure', 'timeFrame': '4 hours', 'description': 'Clinical tissue perfusion parameters will be measured clinically every 30 minutes, as usual in patients with sepsis/septic shock.'}, {'measure': 'Diuresis', 'timeFrame': '4 hours', 'description': 'Clinical tissue perfusion parameters will be measured clinically every 30 minutes, as usual in patients with sepsis/septic shock.'}, {'measure': 'Variations in cardiac flow', 'timeFrame': '4 hours', 'description': 'Clinical tissue perfusion parameters will be measured clinically every 30 minutes, as usual in patients with sepsis/septic shock.'}, {'measure': 'Variations in the biological parameters', 'timeFrame': '4 hours', 'description': 'Variations in the biological parameters between H0 and H4 will be analyzed from 5 ml of blood taken in addition, in accordance with the usual practice, in a sepsis/septic shock:\n\n* IL-6, IL-1b, Il-8, TNFa, IL-10\n* Syndecan-1, heparan sulfat, hyaluronat\n* Circulating microparticles'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Endothelial dysfunction', 'Albumin', 'Fluid Therapy', 'Peripheral Tissue Perfusion', 'Septic shock', 'Microcirculatory effects', 'Hemodynamic effects', 'sepsis'], 'conditions': ['Septic Shock', 'Sepsis']}, 'referencesModule': {'references': [{'pmid': '38326920', 'type': 'DERIVED', 'citation': 'Gabarre P, Desnos C, Morin A, Missri L, Urbina T, Bonny V, Turpin M, Baudel JL, Berard L, Montil M, Guidet B, Voiriot G, Joffre J, Maury E, Ait-Oufella H. Albumin versus saline infusion for sepsis-related peripheral tissue hypoperfusion: a proof-of-concept prospective study. Crit Care. 2024 Feb 7;28(1):43. doi: 10.1186/s13054-024-04827-0.'}]}, 'descriptionModule': {'briefSummary': 'Compare the effect of volume expansion by saline versus albumin on the correction of peripheral tissue hypoperfusion by measuring Index skin recoloration time (CRT) at H0 and H1', 'detailedDescription': 'This is a transversal study allowing to compare the effect of volume expansion by saline versus albumin on the correction of peripheral tissue hypoperfusion\n\nDesign:\n\n• A multicentric, open-label, transversal study\n\nSample size :\n\n60 patients\n\nAssessement:\n\nBetween the admission to intensive care and 48 hours after admission, the patient will be included after collection of the non-opposition form.\n\nThe patient will receive volume expansion either by 0.9% saline (500mL) or by 20% albumin (100mL) over 15 minutes.\n\nRepeated clinical measurements will be performed at H0, H0.5 and H1 (respectively at 0, 30 and 60 minutes).\n\nA blood sample will be taken just before the volume expansion and 4 hours after, at the same time as the samples usually taken as part of the treatment.\n\nNo interim analysis is planned. Analysis will be performed at the end of the study after data review and freezing of data base.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with sepsis/septic shock hospitalized in intensive care with signs of peripheral hypoperfusion persisting despite the initial resuscitation.\n\nSeptic shock corresponds to patients with sepsis (infection + 2 SOFA points according to the latest international definition and the need to administer noradrenaline to maintain mean arterial pressure\\> 65 mmHg.\n\nIn total, patients with reanimated and hemodynamically stabilized sepsis/septic shock will be included. The diagnostic and therapeutic management will comply in all points with the usual service protocol and international recommendations.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age\\> 18 years old\n* Sepsis or\n* Septic shock within 24 hours of admission to intensive care with a stable dose of norepinephrine for at least 2 hours to maintain MAP\\> 65mmHg\n* CRT index\\> 3 seconds despite the initial resuscitation (administration of antibiotics, volume expansion by crystalloids of 20 mL / Kg, noradrenaline started) between the admission to intensive care and H48 from admission to intensive care\n* Non-opposition of the patient collected by the doctor in charge of the patient between H0 and H6 after admission if the patient is vigilant, otherwise a procedure for collecting non-opposition from relatives will be carried out with collection of the non-opposition of the patient once he is able to give it.\n* Affiliation to a social security regimen (excluding AME)\n\nExclusion Criteria:\n\n* Patient COVID-19 (+) with respiratory impairment\n* Pregnant and lactating woman\n* Patient under Guardianship / Curatorship\n* Refusal to participate\n* CRT not evaluable (dark or damaged skin)\n* Moribund patient\n* Estimated life expectancy less than 1 month\n* Participation in another interventional research involving the human person or period of exclusion at the end of a previous research involving the human person'}, 'identificationModule': {'nctId': 'NCT05094856', 'acronym': 'REPTILOS', 'briefTitle': 'Effects of Fluid Therapy on Peripheral TIssse Perfusion During Sepsis/Septic Shock', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Effects of Fluid Therapy on Peripheral TIssue Perfusion During Sepsis/Septic Shock', 'orgStudyIdInfo': {'id': 'APHP210918'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Effect of volume expansion by albumin on the correction of peripheral tissue hypoperfusion', 'description': 'Effect of volume expansion by albumin on the correction of peripheral tissue hypoperfusion by measuring the proportion of patients who normalized their cutaneous re-coloring time (CRT) measured at the index level, defined by a value \\<3 seconds at H1. The clinical measurement method has been standardized in the participating departments and has been used for several years in clinical practice.'}, {'label': 'Effect of volume expansion by saline on the correction of peripheral tissue hypoperfusion', 'description': 'Effect of volume expansion by saline on the correction of peripheral tissue hypoperfusion by measuring the proportion of patients who normalized their cutaneous re-coloring time (CRT) measured at the index level, defined by a value \\<3 seconds at H1. The clinical measurement method has been standardized in the participating departments and has been used for several years in clinical practice.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '75012', 'city': 'Paris', 'country': 'France', 'facility': 'Intensive care department, Hôpital Saint Antoine', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Hafid AIT-OUFELLA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'collaborators': [{'name': 'Grifols (funder)', 'class': 'UNKNOWN'}, {'name': 'Institut National de la Santé Et de la Recherche Médicale, France', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}