Safety & Efficacy of RenalGuard® Therapy in the Prevention of Cardiac Surgery Associated Acute Kidney Injury

ConditionsCardiac Surgery Associated - Acute Kidney Injury AKI - Acute Kidney Injury

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorCardioRenal Systems, Inc.

About this trial

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).

The study is planned to be conducted in 2 clinical sites in the Malaysia - Universiti Malaya Medical Centre and Institut Jantung Negara, Kuala Lumpur, Malaysia.

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or female and >18 years old.

Patient able to give written consent.

coronary artery bypass graft (CABG)

aortic valve replacement or repair alone, with or without aortic root repair

Disqualifiers

Patient requiring emergency surgery

Surgery to be performed without CPB

Patient receiving furosemide at a dose>100 mg/day orally (or the equivalent dose of an alternative loop diuretic) in the last week

Patient who cannot be urethrally catheterize for any reason

Trial design

Design model

Parallel

Treatments tested in this trial

RenalGuard® Therapy
Device
RenalGuard Therapy®
Standard of Care (SOC)
Other intervention
Standard of care

Treatment groups

300 Participants

are divided into 2 treatment groups

Group A: ControlOther 1 intervention

Group B: Study GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

Incidence of cardiac surgery-associated acute kidney injury (CSA-AKI) occurring within 72 hours following surgery in the RenalGuard versus Control group

Rate of CSA-AKI as defined by the KDIGO definition i.e. as when any one 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

Time frame

Within 72 hours

Secondary outcomes

AKI severity as defined by KDIGO stage definition, with stage distribution between the study groups at 72 hours post-surgery AKI stage

The staging of AKI (KDIGO) is based on the following criteria: Stage 1 Increase ≥ 26 μmol/L within 72 hrs or Increase 1.5 to 1.9 times from baseline Stage 2 Increase 2 to 2.9 x reference creatinine Stage 3 Increase ≥3 X reference creatinine or increase 354 μmol/L or need for RRT

Time frame

72 hours

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

CardioRenal Systems, Inc.

Lead sponsor

University Malaysia Medical Centre

Collaborator

Institut Jantung Negara