Biomarker-guided Implementation of the AKI Bundle
- Conditions
- Acute Kidney Injury (Nontraumatic)
- Interventions
- Other: Intervention
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 280
- Adult patients undergoing cardiac surgery with cardiopulmonary bypass (CPB)
- Urinary [TIMP-2] * [IGFBP7] >= 0.3 4h after CPB
- Written informed consent
- 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
- Arm && Interventions
Group Intervention Description Intervention group Intervention 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
- 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 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 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)
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
Trial Locations
- Locations (12)
Hospital del la Santa Creu i Sant Pau; Unidad de Cuidados Intensivos
🇪🇸Barcelona, Spain
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
University Hospital Muenster
🇩🇪Muenster, Germany
Philipps-Universität Marburg
🇩🇪Marburg, 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
St. Thomas' Hospital
🇬🇧London, United Kingdom
King's College Hospital
🇬🇧London, United Kingdom