Ignite Creation Date:
2025-12-24 @ 10:14 PM
Ignite Modification Date:
2026-01-02 @ 2:58 AM
Study NCT ID:
NCT03178435
Status:
COMPLETED
Last Update Posted:
2019-02-26
First Post:
2017-06-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preventing Acute Kidney Injury and Improving Outcome in Critically Ill Patients Utilising Risk Prediction Score
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058186', 'term': 'Acute Kidney Injury'}, {'id': 'D016638', 'term': 'Critical Illness'}], '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'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'interventional cluster randomised trial -pilot /feasibility study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 198}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2018-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-25', 'studyFirstSubmitDate': '2017-06-04', 'studyFirstSubmitQcDate': '2017-06-06', 'lastUpdatePostDateStruct': {'date': '2019-02-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of AKI', 'timeFrame': 'during 7 days of ICU admission', 'description': 'We will compare the incidence rate between the interventional and the observational arm'}], 'secondaryOutcomes': [{'measure': '30 day mortality', 'timeFrame': '30 days', 'description': 'all cause mortality during 30 days of ICU admission or within 30 days of developement of AKI'}, {'measure': 'Time to recovery after development of AKI', 'timeFrame': '30 days', 'description': 'Time interval between the diagnosis of AKI and recovery of either blood chemistry or oliguria'}, {'measure': 'Deterioration of AKI stage', 'timeFrame': '30 days', 'description': 'Transition from initial stage KDIGO stage 1 to either 2 or 3 .Transition from initial stage 2 to 3'}, {'measure': 'Duration of dialysis dependency', 'timeFrame': '30 days', 'description': 'time patient remains dialysis-dependant after severe AKI.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['risk score', 'Acute kidney injury', 'critical care'], 'conditions': ['Acute Kidney Injury', 'Critical Illness']}, 'descriptionModule': {'briefSummary': 'An interventional controlled trial to test the feasibility of applying risk score based prevention for critically ill patient at high risk to develop acute kidney injury (AKI)', 'detailedDescription': 'Background and rationale AKI is common in the intensive care unit .It contributes significantly to mortality and morbidity .the estimated incidence or AKI among critically ill patients is 30-40% and morality is high.\n\nThere is a well recognized gap between the optimal care and the delivered care regarding prevention and management of AKI.\n\nThe focus over the last few years has been on early detection. A panel of urinary biomarkers have proved helpful for early detection of AKI. However the cost and low specificity make no single one of them solely reliable .using a panel of bio-markers increases their specificity.\n\nThe concept of electronic alerts has been recently introduced. Some trials have been testing its impact on the outcome of AKI. The benefit of electronic alerts is still uncertain .A meta-analysis is currently underway to synthesize stronger evidence of electronic alerts benefit.\n\nAnother evolving area, is the development of risk score to predict AKI and and hence applying timely preventive measures.\n\nKDIGO recommends applying preventive measures to high risk patients. However no study to date has tested risk scores based interventions\n\nHypothesis:\n\nWe will use the recently validated score to predict AKI in ICU patients. We will then apply preventive measures. To patients at risk .To our knowledge this is the first study to apply preventive interventions based on AKI risk score assessment'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAll adult patients (≥18 year old) admitted to the intensive care unit and do not fulfill the criteria for the diagnosis of AKI by Kidney Disease Improving Global Outcome (KDIGO) definition\n\nExclusion Criteria:\n\n1. Patients who have already developed AKI at the time of intensive care unit ICU admission.\n2. Patients with insufficient medical records to obtain previous medical history\n3. Patients who lack mental capacity'}, 'identificationModule': {'nctId': 'NCT03178435', 'acronym': 'PRAIOC-RISKS', 'briefTitle': 'Preventing Acute Kidney Injury and Improving Outcome in Critically Ill Patients Utilising Risk Prediction Score', 'organization': {'class': 'OTHER', 'fullName': 'Kasr El Aini Hospital'}, 'officialTitle': 'Preventing Acute Kidney Injury and Improving Outcome in Critically Ill Patients Utilising Risk Prediction Score - a Pilot Feasibility Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'KA-13050'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Observational', 'description': 'patients will be recruited to this arm to observe prospectively the incidence of AKI among critically ill patients.patients will receive the standard care.No other intervention will be delivered'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Interventional', 'description': 'Patients in this arm will be subject to AKI risk score. This risk score was recently developed and validated in Mayo clinic the intervention will be Measures to prevent AKI among critically ill patients', 'interventionNames': ['Other: Measures to prevent AKI among critically ill patients']}], 'interventions': [{'name': 'Measures to prevent AKI among critically ill patients', 'type': 'OTHER', 'description': '1. Meticulous optimization of the fluid balance\n2. Avoidance of nephrotoxic medications where possible\n3. Optimisation of the hemodynamic status\n4. Avoidance of blood transfusion unless marked acute blood loss or symptomatic anemia\n5. Optimization of the underlying medical condition\n6. Seek expert renal advise when necessary', 'armGroupLabels': ['Interventional']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Cairo university hospitals', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kasr El Aini Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior lecturer', 'investigatorFullName': 'Tarek Samy Abdelaziz', 'investigatorAffiliation': 'Kasr El Aini Hospital'}}}}