Biomarker-guided Implementation of the AKI Bundle

University Hospital Muenster280 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

TRIPLE

Enrollment

280

Conditions

Acute Kidney Injury (Nontraumatic)

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (12)

CHU Brugmann, Intensive Care Medicine

Brussels, Belgium

AZ Maria Middelares

Ghent, Belgium

Universitair Ziekenhuis Gent

Ghent, Belgium

Universitätsklinikum Bergmannsheil Bochum

Bochum, Germany

Universitätsklinikum Gießen, Klinik für Herz-, Kinderherz- und Gefäßchirurgie

Giessen, Germany

Philipps-Universität Marburg

Marburg, Germany

University Hospital Muenster

Münster, Germany

Ospedale San Raffaele S.r.I., I.R.C.C.S.

Milan, Italy

Centro Cardiologico Monzino Istituto di Ricovero e Cura a Carattere Scientific

Milan, Italy

Hospital del la Santa Creu i Sant Pau; Unidad de Cuidados Intensivos

Barcelona, Spain

...and 2 more locations

Outcomes

Primary Outcomes

Compliance rate

proportion of patients who are treated according to the trial protocol: CV surgery AKI bundle fulfilled at all time

Time frame: 48 hours after start of intervention

Secondary Outcomes

Occurence of AKI

Time frame: 72 hours after start of intervention

Moderate and severe AKI

Time frame: 72 hours after start of intervention

Free-days through of vasoactive medications and mechanical ventilation

Time frame: 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)

Time frame: 90 days after start of intervention

Mortality

Time frame: 90 days after start of intervention

ICU and hospital stay

Time frame: up to 1 year after start of intervention (until discharge)

Number of patients with renal replacement therapy

Time frame: 90 days after start of intervention