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

NCT07123935 | Not Yet Recruiting

• 1 other identifier: RG-CSA-AKI-Malaysia-003
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Cardiac Surgery Associated - Acute Kidney Injury; AKI - Acute Kidney Injury

Keywords

acute kidney injury; cardiac surgery; RenalGuard Therapy; matched enhanced diuresis

Outcome Measures

Primary Outcomes (1)

• 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

  Within 72 hours

Secondary Outcomes (1)

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

  72 hours

Study Arms (2)

Control

OTHER

Current Standard of Care

Other: Standard of Care (SOC)

Study Group

ACTIVE COMPARATOR

Patient with RenalGuard® Therapy

Device: RenalGuard® Therapy

Interventions

RenalGuard® Therapy DEVICE

RenalGuard Therapy®

Study Group

Standard of Care (SOC) OTHER

Standard of care

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female and \>18 years old.
• Patient able to give written consent.
• Scheduled for the following non-emergent cardiac surgery procedure requiring CPB, isolated or in combination:
• coronary artery bypass graft (CABG)
• aortic valve replacement or repair alone, with or without aortic root repair
• mitral, tricuspid, or pulmonic valve replacement or repair
• simultaneous replacement of several cardiac valves
• CABG with aortic, mitral, tricuspid, or pulmonic valve replacement or repair
• Surgery on the aorta: aortic root and/ or ascending aorta
• AF ablation surgery if combined with other cardiac procedures.
• ASD closure if combined with other cardiac procedures.
• Excision of myxoma if combined with other cardiac procedures
• Have at least one of the following risk factors for CSA-AKI:
• CKD-EPI eGFR 20-59 mL/min/1.73 m²
• Undergoing combined surgery (e.g. CABG + Valve)

You may not qualify if:

• 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
• Patients already dialysis dependent
• Patients with CKD-EPI eGFR \<20 mL/min/1.73 m²
• Known or suspected AKI (KDIGO criteria) at the time of screening
• IV contrast within 48 hours of surgery
• Patients participating in another interventional drug or device study or have received an investigational drug or device treatment within the last 30 days
• Pregnant patient, self-reported
• Patients whose planned surgery to be performed under conditions of circulatory arrest or hypothermia with rectal temperature \< 28°Celsius (82.4° Fahrenheit)
• Patient with suspected or confirmed bacteraemia, endocarditis, or pyelonephritis at hospital admission
• Patients with pneumonia, aspiration, or bilateral pulmonary infiltrates from an infectious aetiology reported on chest x-ray or CT scan in the last 7 days
• Patients in cardiogenic shock or hemodynamic instability which require inotropes or vasopressors or other mechanical devices (Impella, IABP) within 24 hours prior to surgery
• Patients on extracorporeal membrane oxygenation (ECMO) or durable ventricular assist device (VAD) at the time of screening, or planned use within 24h prior to surgery

Sponsors & Collaborators

• CardioRenal Systems, Inc.: lead
• University Malaysia Medical Centre: collaborator
• Institut Jantung Negara: collaborator

Study Sites (2)

Institut Jantung Negara

Kuala Lumpur, Malaysia

Location

Universiti Malaya Medical Centre

Kuala Lumpur, Malaysia

Location

Related Publications (8)

• Luckraz H, Giri R, Wrigley B, Nagarajan K, Senanayake E, Sharman E, Beare L, Nevill A. Reduction in acute kidney injury post cardiac surgery using balanced forced diuresis: a randomized, controlled trial. Eur J Cardiothorac Surg. 2021 Apr 13;59(3):562-569. doi: 10.1093/ejcts/ezaa395.

  PMID: 33236105 BACKGROUND

• Redfors B, Bragadottir G, Sellgren J, Sward K, Ricksten SE. Effects of norepinephrine on renal perfusion, filtration and oxygenation in vasodilatory shock and acute kidney injury. Intensive Care Med. 2011 Jan;37(1):60-7. doi: 10.1007/s00134-010-2057-4. Epub 2010 Oct 15.

  PMID: 20949349 BACKGROUND

• Brown JK, Shaw AD, Mythen MG, Guzzi L, Reddy VS, Crisafi C, Engelman DT; PeriOperative Quality Initiative and the Enhanced Recovery After Surgery Cardiac Workgroup. Adult Cardiac Surgery-Associated Acute Kidney Injury: Joint Consensus Report. J Cardiothorac Vasc Anesth. 2023 Sep;37(9):1579-1590. doi: 10.1053/j.jvca.2023.05.032. Epub 2023 May 23.

  PMID: 37355415 BACKGROUND

• Luckraz H, Giri R, Wrigley B, Hennessy AM, Nicholas J, Nevill A. The use of the RenalGuard system in cardiac surgery with cardiopulmonary bypass: a first in man prospective, observational, feasibility pilot study. Open Heart. 2017 Oct 10;4(2):e000669. doi: 10.1136/openhrt-2017-000669. eCollection 2017.

  PMID: 29071091 BACKGROUND

• Lau D, Pannu N, James MT, Hemmelgarn BR, Kieser TM, Meyer SR, Klarenbach S. Costs and consequences of acute kidney injury after cardiac surgery: A cohort study. J Thorac Cardiovasc Surg. 2021 Sep;162(3):880-887. doi: 10.1016/j.jtcvs.2020.01.101. Epub 2020 Mar 3.

  PMID: 32299694 BACKGROUND

• Zarbock A, Kullmar M, Ostermann M, Lucchese G, Baig K, Cennamo A, Rajani R, McCorkell S, Arndt C, Wulf H, Irqsusi M, Monaco F, Di Prima AL, Garcia Alvarez M, Italiano S, Miralles Bagan J, Kunst G, Nair S, L'Acqua C, Hoste E, Vandenberghe W, Honore PM, Kellum JA, Forni LG, Grieshaber P, Massoth C, Weiss R, Gerss J, Wempe C, Meersch M. Prevention of Cardiac Surgery-Associated Acute Kidney Injury by Implementing the KDIGO Guidelines in High-Risk Patients Identified by Biomarkers: The PrevAKI-Multicenter Randomized Controlled Trial. Anesth Analg. 2021 Aug 1;133(2):292-302. doi: 10.1213/ANE.0000000000005458.

  PMID: 33684086 BACKGROUND

• Mishra PK, Luckraz H, Nandi J, Nevill A, Giri R, Panayiotou A, Nicholas J. Long-term quality of life postacute kidney injury in cardiac surgery patients. Ann Card Anaesth. 2018 Jan-Mar;21(1):41-45. doi: 10.4103/aca.ACA_104_17.

  PMID: 29336390 BACKGROUND

• Hoste EAJ, Kellum JA, Selby NM, Zarbock A, Palevsky PM, Bagshaw SM, Goldstein SL, Cerda J, Chawla LS. Global epidemiology and outcomes of acute kidney injury. Nat Rev Nephrol. 2018 Oct;14(10):607-625. doi: 10.1038/s41581-018-0052-0.

  PMID: 30135570 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Krishnasamy Professor Dr. Sivakumar

  Universiti Malaya Medical Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Krishnasamy Professor Dr. Sivakumar

CONTACT

+6017 345 3839; sivakumar@um.edu.my

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2025
• First Posted: August 14, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: August 14, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

MY (2)