Ignite Creation Date:
2025-12-24 @ 9:07 PM
Ignite Modification Date:
2026-01-01 @ 4:24 PM
Study NCT ID:
NCT06640504
Status:
COMPLETED
Last Update Posted:
2025-11-28
First Post:
2024-10-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Serum Albumin Ratios Can Improve Sepsis Mortality Prediction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-09-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2024-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-22', 'studyFirstSubmitDate': '2024-10-11', 'studyFirstSubmitQcDate': '2024-10-11', 'lastUpdatePostDateStruct': {'date': '2025-11-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The proportion of patients reported having at least a 50% lower risk of mortality in surgical ICU (measured by the APACHE II Scale) in correlation with blood biomarkers ratio.', 'timeFrame': '1 month', 'description': 'The diagnostic value of blood biomarkers ratio as lactate-to-albumin ratio (LAR), CRP-to-albumin ratio (CAR), and procalcitonin (PCT)-to-albumin ratio (PAR) in decreased sepsis mortality according to APACHE II Scale.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sepsis']}, 'descriptionModule': {'briefSummary': 'Sepsis remains a leading cause of mortality in hospitalized patients, despite advancements in critical care. Existing clinical scores for predicting sepsis outcomes often lack generalizability and complexity, hindering accurate risk assessment and timely intervention. This study aimed to evaluate the prognostic performance of serum albumin ratios to C-reactive protein (CRP), procalcitonin (PCT), and lactate in predicting 28-day morbidities and mortality in sepsis patients admitted to surgical ICUs. By incorporating these albumin ratios into clinical decision-making, we hypothesized that clinicians could more accurately identify patients at high risk of adverse outcomes and tailor treatment strategies accordingly.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '12 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population consisted of all patients admitted to the Surgical Intensive Care Unit with manifestations suggestive of sepsis according to the guidelines of the 3rd International Consensus definitions for sepsis and septic shock.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients newly admitted to ICU with sepsis or septic shock;\n* Patients were free of exclusion criteria.\n\nExclusion Criteria:\n\n* Patients with acute kidney injury;\n* Patients with hemorrhagic shock;\n* Patients with immunosuppressive or autoimmune disorders;\n* Patients suspected to die in ICU.'}, 'identificationModule': {'nctId': 'NCT06640504', 'briefTitle': 'Serum Albumin Ratios Can Improve Sepsis Mortality Prediction', 'organization': {'class': 'OTHER', 'fullName': 'Benha University'}, 'officialTitle': 'Serum Albumin Ratios Correct the Ability of Traditional Biomarkers to Predict Mortality of Sepsis Patients Admitted to Surgical ICU', 'orgStudyIdInfo': {'id': 'Rc 4-9-2024'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1', 'description': 'Patients newly admitted to ICU with sepsis or septic shock with manifestations suggestive of sepsis according to the guidelines of the 3rd International consensus definitions for sepsis and septic shock.', 'interventionNames': ['Diagnostic Test: serum albumin', 'Diagnostic Test: C-Reactive Protein', 'Diagnostic Test: Serum procalcitonin', 'Drug: Blood Lactate']}], 'interventions': [{'name': 'serum albumin', 'type': 'DIAGNOSTIC_TEST', 'description': 'Serum albumin ratios were calculated as the ratio between the estimated blood lactate, and serum levels of CRP and PCT divided by the estimated serum albumin level to get the lactate-to-albumin ratio (LAR), CRP-to-albumin ratio (CAR) and procalcitonin (PCT)-to-albumin ratio (PAR).', 'armGroupLabels': ['Group 1']}, {'name': 'C-Reactive Protein', 'type': 'DIAGNOSTIC_TEST', 'description': 'The serum levels of C-reactive protein (CRP) are divided by the estimated serum albumin level to get the CRP-to-albumin ratio (CAR).', 'armGroupLabels': ['Group 1']}, {'name': 'Serum procalcitonin', 'type': 'DIAGNOSTIC_TEST', 'description': 'The serum levels of procalcitonin (PCT) are divided by the estimated serum albumin level to get the PCT-to-albumin ratio (PAR).', 'armGroupLabels': ['Group 1']}, {'name': 'Blood Lactate', 'type': 'DRUG', 'description': 'The serum levels of blood lactate are divided by the estimated serum albumin level to get the lactate-to-albumin ratio (LAR).', 'armGroupLabels': ['Group 1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13511', 'city': 'Banhā', 'state': 'El Qalyoubia', 'country': 'Egypt', 'facility': 'Benha University', 'geoPoint': {'lat': 30.45977, 'lon': 31.1842}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Benha University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Anesthesia, Pain & ICU', 'investigatorFullName': 'Azza Mahrous Shaffik', 'investigatorAffiliation': 'Benha University'}}}}