Ignite Creation Date:
2025-12-25 @ 5:06 AM
Ignite Modification Date:
2025-12-26 @ 4:10 AM
Study NCT ID:
NCT07242027
Status:
COMPLETED
Last Update Posted:
2025-11-21
First Post:
2025-09-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Use of Lactate-to-Albumin, CRP-to-Albumin, and Procalcitonin-to-Albumin Ratios to Predict Mortality in ICU Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D012131', 'term': 'Respiratory Insufficiency'}, {'id': 'D006323', 'term': 'Heart Arrest'}, {'id': 'D012769', 'term': 'Shock'}, {'id': 'D016638', 'term': 'Critical Illness'}, {'id': 'D016757', 'term': 'Death, Sudden, Cardiac'}], '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': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D003645', 'term': 'Death, Sudden'}, {'id': 'D003643', 'term': 'Death'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 212}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-03-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-09-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-18', 'studyFirstSubmitDate': '2025-09-15', 'studyFirstSubmitQcDate': '2025-11-18', 'lastUpdatePostDateStruct': {'date': '2025-11-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-07-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'In-hospital mortality', 'timeFrame': '100 days from the date of ICU admission', 'description': 'All-cause in-hospital mortality among ICU patients during the index hospitalization.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['LAR', 'CAR', 'PAR', 'ICU', 'mortality', 'prediction'], 'conditions': ['Sepsis', 'Respiratory Failure', 'Cardiac Arrest', 'Circulatory Failure', 'Critical Illness', 'Sudden Cardiac Arrest']}, 'descriptionModule': {'briefSummary': 'This observational study aims to determine whether three blood test ratios - lactate-to-albumin, CRP-to-albumin, and procalcitonin-to-albumin - can predict in-hospital mortality among critically ill adults. The study includes all adult patients admitted in 2024 to the ICU Ward B at the Silesian Center for Heart Diseases (SCCS) in Zabrze. Researchers will analyze retrospective clinical and laboratory data from electronic medical records, including lab values collected at ICU admission, patient demographics, diagnoses, and outcomes. The biomarker ratios will be manually calculated in Excel and statistically evaluated. The main goal is to assess whether these ratios are associated with patient survival and to identify predictive cut-off values to support early risk stratification in the ICU setting.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients admitted to the ICU. Data collected retrospectively from clinical records (AMMS system).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years\n* Admission to ICU in 2024\n* Availability of data for lactate, CRP, procalcitonin, and albumin\n\nExclusion Criteria:\n\n* Missing outcome data (e.g. unknown survival status)\n* Lack of laboratory parameters necessary for ratio calculation'}, 'identificationModule': {'nctId': 'NCT07242027', 'acronym': 'LAR-CAR-PAR', 'briefTitle': 'Use of Lactate-to-Albumin, CRP-to-Albumin, and Procalcitonin-to-Albumin Ratios to Predict Mortality in ICU Patients', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Silesia'}, 'officialTitle': 'Lactate-to-albumin, CRP-to-albumin and Procalcitonin-to-albumin Ratios Predict Mortality in Critically Ill Adults: a Retrospective ICU Cohort Study', 'orgStudyIdInfo': {'id': 'SUM-SKNIPG-LARCARPAR-ICU-2025'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Survivors', 'description': 'Critically ill adult patients admitted to the ICU who survived hospitalization and were discharged alive.'}, {'label': 'Non-Survivors', 'description': 'Critically ill adult patients admitted to the ICU who died during the course of hospitalization.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '41-800', 'city': 'Zabrze', 'state': 'Silesian Voivodeship', 'country': 'Poland', 'facility': 'Department of Acute Medicine, Faculty of Medical Sciences in Zabrze, Medical University of Silesia in Katowice, Poland', 'geoPoint': {'lat': 50.32492, 'lon': 18.78576}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The individual participant data (IPD) will not be shared due to the retrospective nature of the study and the use of sensitive patient health records. The dataset is not publicly available, and consent for external data sharing was not obtained from participants or their legal representatives.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Silesia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}