Safety & Efficacy of RenalGuard® Therapy in the Prevention of Cardiac Surgery Associated 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
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
Treatments tested in this trial
- RenalGuard® Therapy
- Standard of Care (SOC)
Treatment groups
300 Participants
are divided into 2 treatment groupsSponsors and collaborators
CardioRenal Systems, Inc.
Lead sponsor
University Malaysia Medical Centre
Collaborator
Institut Jantung Negara
Collaborator
Source ClinicalTrials.gov