Biomarker Guided Intervention for Prevention of Acute Kidney Injury
BigpAK
1 other identifier
interventional
135
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2015
CompletedFirst Submitted
Initial submission to the registry
July 7, 2015
CompletedFirst Posted
Study publicly available on registry
July 16, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2017
CompletedMay 5, 2017
May 1, 2017
1.5 years
July 7, 2015
May 4, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence and severity of AKI in both group
incidence and severity of AKI according to AKI network definition within 90 days will be monitored
90 days
Secondary Outcomes (6)
need for renal replacement therapy,
90 days
length of ICU stay
90 days
length of hospital stay
90 days
ICU and hospital costs
90 days
incidence of chronic kidney disease (CKD)
90 days
- +1 more secondary outcomes
Study Arms (2)
standard care
PLACEBO COMPARATORPatients in the standard care population receive - if biomarkers are elevated -treatment of AKI in accordance with KDIGO 2012 guidelines
interventional care
ACTIVE COMPARATORPatients 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
Interventions
biomarker guided volume substitution with Ionosteril
Eligibility Criteria
You may qualify if:
- major surgery with a duration \> 4 hours plus one of the following criteria:
- age \> 75 years, or
- sepsis, or
- shock, or
- polytrauma, or
- need for invasive ventilation or catecholamines, or
- intra-operative application of contrast-medium, or
- preexisting chronic kidney disease (CKD1-4),
- informed consent
You may not qualify if:
- age \< 18 years,
- end stage renal disease (ESRD),
- preexisting dialysis,
- withdrawal of consent,
- pregnancy,
- breastfeeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital Center Regensburg
Regensburg, 93042, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tobias Bergler, MD
UKR-Department of Nephrology
- PRINCIPAL INVESTIGATOR
Ivan Göcze, MD
UKR-Department of Surgery
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PD Dr Tobias Bergler, MD
Study Record Dates
First Submitted
July 7, 2015
First Posted
July 16, 2015
Study Start
June 1, 2015
Primary Completion
December 1, 2016
Study Completion
January 1, 2017
Last Updated
May 5, 2017
Record last verified: 2017-05