Biomarker-guided Implementation of the AKI Bundle

Study Overview
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Brief Summary
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There is no specific therapy for acute kidney injury. It is presumed that supportive measures improve the care and outcome of patients with acute kidney injury. The investigators hypothesize that the implementation of a bundle of supportive measures adapted to patients undergoing cardiovascular surgery reduces the occurence of AKI. A Randomized prospective multicenter trial is needed to investigate whether the implementation of the bundle of measures is effective to prevent AKI in high risk patients undergoing cardiac surgery. In this feasibility trial the investigators will analyze the compliance rate to the trial protocol in a multicenter, multinational cohort in preparation for a large randomized controlled trial.

Official Title
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Biomarker-guided Implementation of the Cardiovascular (CV) Surgery AKI Bundle to Reduce the Occurrence of AKI After Cardiac Surgery- Prevention of AKI

Conditions
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Acute Kidney Injury (Nontraumatic)

Intervention / Treatment
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* Other: Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients undergoing cardiac surgery with cardiopulmonary bypass (CPB) Urinary [TIMP-2] * [IGFBP7] >= 0.3 4h after CPB Written informed consent Exclusion Criteria: Preexisting AKI (stage 1 and higher) Patients with cardiac assist devices (ECMO, LVAD, RVAD, IABP) Pregnancy, breastfeeding Known (Glomerulo-)-Nephritis, intersstitial nephritis or vasculitis CKD with eGFR < 20 mL/min Dialyses dependent CKD Prior kidney transplant within the last 12 months

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Implementation of the cardiovascular surgery AKI bundle discontinuation of all nephrotoxic agents when possible optimization of volume status and hemodynamic parameters close monitoring of serum creatinine, fluid balance and urinary output avoidance of hyperglycemia considerations of alternatives to radiocontrast agents discontinuation of angiotensin converting enzyme inhibitors and angiotensin receptor blockers in the perioperative period avoidance of HES, gelatin, and chlorid-rich solutions | Other: Intervention<br>* Implementation of the cardiovascular AKI bundle (see arm description)<br>|
| No Intervention: Control group<br>The patients will receive standard of care (according to each center) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compliance rate | proportion of patients who are treated according to the trial protocol: CV surgery AKI bundle fulfilled at all time | 48 hours after start of intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurence of AKI |  | 72 hours after start of intervention | 
| Moderate and severe AKI |  | 72 hours after start of intervention | 
| Free-days through of vasoactive medications and mechanical ventilation |  | 28 days after start of intervention | 
| Renal recovery | renal recovery is defined as serum creatinine levels < 0.5 mg/dl higher than baseline serum creatinine (creatinine level before surgery) | 90 days after start of intervention | 
| Mortality |  | 90 days after start of intervention | 
| ICU and hospital stay |  | up to 1 year after start of intervention (until discharge) | 
| Number of patients with renal replacement therapy |  | 90 days after start of intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cardiac surgery, KDIGO-Guideline