The goal of this clinical trial is to assess the effect of RenalGuard Therapy in reducing the rates of Acute Kidney Injury (AKI) within 72 hours after cardiac surgery in patients at risk of developing Cardiac Surgery Associated AKI (CSA-AKI) compared to standard-of-care (SoC). Participants will be randomized (1:1) to one of the two study groups. The Treatment study group will be managed with the RenalGuard System. The RenalGuard treatment will start after induction of anesthesiology and will run during surgery and for 6-7 hours in the Intensive Care Unit (ICU). The treatment will aim to achieve a urine rate above a predefined urine rate threshold. Patients in the control group will be managed based on the usual clinical practice in cardiac surgery centres as detailed in the recommendations for CSA-AKI prevention by accepted clinical guidelines. For both study groups general anaesthesia, cardiopulmonary bypass (CPB) run and overall patient care will be based on SoC for cardiac surgery. Patients will be followed up for up to 7 days post surgery or until discharge, which ever comes first. Long-term follow up will be performed at 90 days post surgery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
300
RenalGuard Therapy
Standard of care
Jessa Medica Center
Hasselt, Belgium
TUM Klinikum Deutsches Herzzentrum
Munich, Germany
Uniklinikum Munster
Münster, Germany
Rambam Medical Center
Haifa, Israel
Rabin Medical Center - Belinson Campus
Petah Tikva, Israel
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain
Hospital Universitario Ramón y Cajal
Madrid, Spain
Sahlgrenska University Hospital
Gothenburg, Sweden
CSA-AKI incidence between study groups
CSA-AKI is defined as when any of the following three criteria are met: 1. An increase in serum creatinine (SCr) by ≥0.3 mg/dl (≥26.5 umol/l) within 72 hours compared to the baseline value; OR 2. An increase in SCr by ≥1.5 times from SCr value at baseline within 72 hours; OR 3. Use of Renal Replacement Therapy (RRT) within 7 days of surgery or by hospital discharge (whichever is the earliest)
Time frame: Within 72 hours
A composite safety endpoint which includes: Significant severe clinically meaningful change in electrolytes (K+, Mg+2, Na+), New onset of postoperative atrial fibrillation, and Pulmonary edema
Time frame: Within 72 hours
CSA-AKI Stage
CSA-AKI severity by stage distribution between the study groups
Time frame: Within 72 hours
CSA-AKI Incidence
AKI incidence within 7 days based on the KDIGO definition described in the primary endpoint section
Time frame: Within 7 days
CSA-AKI Duration
Duration of AKI within 7 days of surgery
Time frame: Within 7 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.