Biomarker-guided Implementation of the AKI Bundle

Not Applicable

Completed

• Conditions: Acute Kidney Injury (Nontraumatic)

• Registration Number: NCT03244514
• Lead Sponsor: University Hospital Muenster

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-07-07
• Study First Submitted QC: 2017-08-08
• Study First Posted: 2017-08-09
• Study Start: 2017-11-02
• Primary Completion: 2019-10-26
• Study Completion: 2020-01-26
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-18
• Last Update Posted: 2020-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 280

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Compliance rate	48 hours after start of intervention	proportion of patients who are treated according to the trial protocol: CV surgery AKI bundle fulfilled at all time

Secondary Outcome Measures

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

Trial Locations

Locations (12)

CHU Brugmann, Intensive Care Medicine; 🇧🇪 Brussels, Belgium

AZ Maria Middelares; 🇧🇪 Gent, Belgium

Universitair Ziekenhuis Gent; 🇧🇪 Gent, Belgium

Universitätsklinikum Bergmannsheil Bochum; 🇩🇪 Bochum, Germany

Universitätsklinikum Gießen, Klinik für Herz-, Kinderherz- und Gefäßchirurgie; 🇩🇪 Gießen, Germany

Philipps-Universität Marburg; 🇩🇪 Marburg, Germany

University Hospital Muenster; 🇩🇪 Muenster, Germany

Centro Cardiologico Monzino Istituto di Ricovero e Cura a Carattere Scientific; 🇮🇹 Milano, Italy

Ospedale San Raffaele S.r.I., I.R.C.C.S.; 🇮🇹 Milan, Italy

Hospital del la Santa Creu i Sant Pau; Unidad de Cuidados Intensivos; 🇪🇸 Barcelona, Spain

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