Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2026-03-03 @ 8:12 AM
Study NCT ID:
NCT02500394
Status:
COMPLETED
Last Update Posted:
2017-05-05
First Post:
2015-07-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biomarker Guided Intervention for Prevention of Acute Kidney Injury
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 135}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-04', 'studyFirstSubmitDate': '2015-07-07', 'studyFirstSubmitQcDate': '2015-07-14', 'lastUpdatePostDateStruct': {'date': '2017-05-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-07-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence and severity of AKI in both group', 'timeFrame': '90 days', 'description': 'incidence and severity of AKI according to AKI network definition within 90 days will be monitored'}], 'secondaryOutcomes': [{'measure': 'need for renal replacement therapy,', 'timeFrame': '90 days', 'description': 'Number of participants with a need for renal replacement therapy (defined as dialysis within 90 days)'}, {'measure': 'length of ICU stay', 'timeFrame': '90 days', 'description': 'overall length of ICU stay'}, {'measure': 'length of hospital stay', 'timeFrame': '90 days', 'description': 'overall length of ICU stay'}, {'measure': 'ICU and hospital costs', 'timeFrame': '90 days', 'description': 'to account for resulting costs, ICU and hospital cost of the standard care and the interventional patient population are monitored'}, {'measure': 'incidence of chronic kidney disease (CKD)', 'timeFrame': '90 days', 'description': 'Investigators want to see if there are any differences on resulting renal function - different stages of chronic kidney disease (CKD I-V) as a consequence of the performed therapy: standard care accoring to KDIGO guidelines versus interventional care'}, {'measure': 'death', 'timeFrame': '90 days', 'description': 'overall mortality'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['renal replacement therapy'], 'conditions': ['Acute Kidney Injury']}, 'descriptionModule': {'briefSummary': 'This study evaluates the impact of a biomarked guided intervention on the development of acute kidney injury in high risk surgical patients. Eligible patients are screened for marker of tubular stress in the urine; if patient specific results are above a pre-defined cutoff they are randomized into a standard care group or an interventional group in which patients receive intensified volume therapy.', 'detailedDescription': 'This study evaluates the impact of a biomarked guided intervention on the development of acute kidney injury in high risk surgical patients.Used markers have been identified as markers of tubular stress and have been validated in previous studies with more than 1500 patients. The advantage of a biomarker guided approach is the saving of time for the diagnosis a developing acute kidney injury (AKI) in high risk surgical patients, since clinical signs of AKI (rise in creatinine/decline of estimated Glomerular Filtration Rate (eGFR), decline of diuresis). If used biomarkers are above a predefined cutoff within \\< 4 hours after surgery, patients are randomized in to a standard care population receiving treatment in accordance with Kidney Disease Improving Global Outcomes (KDIGO) guidelines. In the intervention population patients receive individual volume therapy (= balanced electrolyte solution (Ionosteril)) (1,25 ml/kg bw up to 5 ml/kg bw for 6 hours). Degree of volume therapy is estimated by several predifined parameters, e.g. central venous pressure (CVP).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '"Inclusion Criteria":\n\n* major surgery with a duration \\> 4 hours plus one of the following criteria:\n* age \\> 75 years, or\n* sepsis, or\n* shock, or\n* polytrauma, or\n* need for invasive ventilation or catecholamines, or\n* intra-operative application of contrast-medium, or\n* preexisting chronic kidney disease (CKD1-4),\n* informed consent\n\nExclusion Criteria:\n\n* age \\< 18 years,\n* end stage renal disease (ESRD),\n* preexisting dialysis,\n* withdrawal of consent,\n* pregnancy,\n* breastfeeding'}, 'identificationModule': {'nctId': 'NCT02500394', 'acronym': 'BigpAK', 'briefTitle': 'Biomarker Guided Intervention for Prevention of Acute Kidney Injury', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Regensburg'}, 'officialTitle': 'Biomarker Guided Intervention to Prevent Development of Acute Kidney Injury in High-risk Surgical Patients', 'orgStudyIdInfo': {'id': '1476-Version 6'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'standard care', 'description': 'Patients in the standard care population receive - if biomarkers are elevated -treatment of AKI in accordance with KDIGO 2012 guidelines', 'interventionNames': ['Procedure: Ionosteril']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'interventional care', 'description': 'Patients in the interventional population receive - if biomarkers are elevated - individualized treatment/volume substitution (balanced electrolyte solution = Ionosteril; 1,25-5 ml/kg/bw/6 hours) ) on the basis of predefined criteria', 'interventionNames': ['Procedure: Ionosteril']}], 'interventions': [{'name': 'Ionosteril', 'type': 'PROCEDURE', 'description': 'biomarker guided volume substitution with Ionosteril', 'armGroupLabels': ['interventional care', 'standard care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '93042', 'city': 'Regensburg', 'country': 'Germany', 'facility': 'University Hospital Center Regensburg', 'geoPoint': {'lat': 49.01513, 'lon': 12.10161}}], 'overallOfficials': [{'name': 'Tobias Bergler, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UKR-Department of Nephrology'}, {'name': 'Ivan Göcze, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UKR-Department of Surgery'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Regensburg', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PD Dr Tobias Bergler, MD', 'investigatorFullName': 'Tobias, Bergler, MD', 'investigatorAffiliation': 'University Hospital Regensburg'}}}}