Ignite Creation Date:
2025-12-25 @ 1:03 AM
Ignite Modification Date:
2026-01-03 @ 5:54 AM
Study NCT ID:
NCT03097393
Status:
COMPLETED
Last Update Posted:
2017-03-31
First Post:
2017-03-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Serum Procalcitonin Level May Predict Acute Kidney Injury in ICU Patients With Sepsis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058186', 'term': 'Acute Kidney Injury'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 67}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2017-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-25', 'studyFirstSubmitDate': '2017-03-25', 'studyFirstSubmitQcDate': '2017-03-25', 'lastUpdatePostDateStruct': {'date': '2017-03-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'development of AKI', 'timeFrame': '28 Days', 'description': 'elevated kidney functions creatinine or oliguria'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Kidney Injury']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to examine if procalcitonin (PCT) can be used for early prediction of AKI septic patients in ICU.', 'detailedDescription': '67 patients with sepsis were enrolled in this study. On admission, PCT was measured together with serum creatinine, urea, and other inflammatory markers. Quick Sepsis-related Organ Failure Assessment was calculated at the emergency department. Patients were classified into those with Acute kidney injury (AKI) and non-AKI groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'ICU patients with sepsis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ICU patients with sepsis\n\nExclusion Criteria:\n\n* Patient known to have End-stage kidney disease\n* Patients on Renal replacement therapy\n* patients without procalcitonin level within 24 hours from admission.'}, 'identificationModule': {'nctId': 'NCT03097393', 'briefTitle': 'Serum Procalcitonin Level May Predict Acute Kidney Injury in ICU Patients With Sepsis', 'organization': {'class': 'OTHER', 'fullName': 'Benha University'}, 'officialTitle': 'Serum Procalcitonin Level May Predict Acute Kidney Injury in ICU Patients With Sepsis', 'orgStudyIdInfo': {'id': 'Benha317'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'AKI GROUP', 'description': 'measure Procalcitonin among Patient developed Acute kidney injury during ICU stay', 'interventionNames': ['Diagnostic Test: measure Serum procalcitonin level']}, {'label': 'Non-AKI group', 'description': 'measure Procalcitonin among Patient did not develop Acute kidney injury during ICU stay', 'interventionNames': ['Diagnostic Test: measure Serum procalcitonin level']}], 'interventions': [{'name': 'measure Serum procalcitonin level', 'type': 'DIAGNOSTIC_TEST', 'description': 'measuring procalcitonin level', 'armGroupLabels': ['AKI GROUP', 'Non-AKI group']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Benha University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer in Internal Medidicne Department- Faculty of Medicine', 'investigatorFullName': 'Mahmoud Hamada imam', 'investigatorAffiliation': 'Benha University'}}}}