Safety & Efficacy of RenalGuard® Therapy in the Prevention of Cardiac Surgery Associated Acute Kidney Injury
NCT ID: NCT07123935
Last Updated: 2025-08-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
300 participants
INTERVENTIONAL
2025-09-01
2027-06-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Control
Current Standard of Care
Standard of Care (SOC)
Standard of care
Study Group
Patient with RenalGuard® Therapy
RenalGuard® Therapy
RenalGuard Therapy®
Interventions
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RenalGuard® Therapy
RenalGuard Therapy®
Standard of Care (SOC)
Standard of care
Eligibility Criteria
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Inclusion Criteria
2. Patient able to give written consent.
3. 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
4. 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)
* STS Score ≥4 or Logistic EuroScore of ≥5 or, Euroscore II of ≥4
* Left ventricular ejection fraction (LVEF) ≤ 35%
* Insulin-requiring diabetes
* Non-insulin-requiring diabetes with HbA1C ≥ 6.1% in the last 6 months
* Preoperative anemia (hemoglobin ≤11g/dl for men and women) within 4 weeks of surgery
Exclusion Criteria
2. Surgery to be performed without CPB
3. Patient receiving furosemide at a dose\>100 mg/day orally (or the equivalent dose of an alternative loop diuretic) in the last week
4. Patient who cannot be urethrally catheterize for any reason
5. Patients already dialysis dependent
6. Patients with CKD-EPI eGFR \<20 mL/min/1.73 m²
7. Known or suspected AKI (KDIGO criteria) at the time of screening
8. IV contrast within 48 hours of surgery
9. Patients participating in another interventional drug or device study or have received an investigational drug or device treatment within the last 30 days
10. Pregnant patient, self-reported
11. Patients whose planned surgery to be performed under conditions of circulatory arrest or hypothermia with rectal temperature \< 28°Celsius (82.4° Fahrenheit)
12. Patient with suspected or confirmed bacteraemia, endocarditis, or pyelonephritis at hospital admission
13. 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
14. Patients in cardiogenic shock or hemodynamic instability which require inotropes or vasopressors or other mechanical devices (Impella, IABP) within 24 hours prior to surgery
15. 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
16. Patients currently treated with chemotherapy or radiation therapy that may have an impact on kidney function.
17. Patient underwent prior solid organ transplantation
18. Patients underwent major surgery within the last 3 months
19. Any condition which, in the judgement of the investigator, might increase the risk to the patient
18 Years
ALL
No
Sponsors
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University Malaysia Medical Centre
UNKNOWN
Institut Jantung Negara
OTHER
CardioRenal Systems, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Krishnasamy Professor Dr. Sivakumar
Role: PRINCIPAL_INVESTIGATOR
Universiti Malaya Medical Centre
Locations
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Institut Jantung Negara
Kuala Lumpur, , Malaysia
Universiti Malaya Medical Centre
Kuala Lumpur, , Malaysia
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
Related Links
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Related Info
Other Identifiers
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RG-CSA-AKI-Malaysia-003
Identifier Type: -
Identifier Source: org_study_id
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