Biomarker-guided Implementation of the AKI Bundle (PrevAKI-mc)

University Hospital Muenster

Status: Completed

Conditions: Acute Kidney Injury (Nontraumatic)

Treatments: Other: Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT03244514

07-AnIt-16

Details and patient eligibility

About

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.

Enrollment: 280 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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280 participants in 2 patient groups

Intervention group

Experimental group

Description:

Implementation of the cardiovascular surgery AKI bundle 1. discontinuation of all nephrotoxic agents when possible 2. optimization of volume status and hemodynamic parameters 3. close monitoring of serum creatinine, fluid balance and urinary output 4. avoidance of hyperglycemia 5. considerations of alternatives to radiocontrast agents 6. discontinuation of angiotensin converting enzyme inhibitors and angiotensin receptor blockers in the perioperative period 7. avoidance of HES, gelatin, and chlorid-rich solutions

Treatment:

Other: Intervention

Control group

No Intervention group

Description:

The patients will receive standard of care (according to each center)