Post-Marketing Study to Assess the Safety & Efficacy of RenalGuard® Therapy for Prevention CSA-AKI

NCT06811805 | Active Not Recruiting DMC

• 1 other identifier: RG-CSA-002
• Study Type: interventional
• Target: 300
• Locations: 5 countries
• Sites: 8

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). 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

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

Keywords

RenalGuard; AKI; Acute Kidney Injury; Cardiac Surgery Associated AKI; CSA-AKI; AKI Prevention; Cardiac Surgery

Outcome Measures

Primary Outcomes (1)

• 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)

  Within 72 hours

Secondary Outcomes (4)

• 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

  Within 72 hours

• CSA-AKI Stage

  Within 72 hours

• CSA-AKI Incidence

  Within 7 days

• CSA-AKI Duration

  Within 7 days

Other Outcomes (3)

• The incidence of Major Adverse Kidney Events (MAKE)

  90 days post-surgery

• ICU and in-hospital length of stay

  7 days

• Cumulative costs of ICU stay

  7 days

Study Arms (2)

Control

ACTIVE COMPARATOR

Standard of care

Other: Standard of Care (SOC)

RenalGuard Therapy

EXPERIMENTAL

RenalGuard Therapy

Device: RenalGuard Therapy

Interventions

Standard of Care (SOC) OTHER

Standard of care

Control

RenalGuard Therapy DEVICE

RenalGuard Therapy

RenalGuard Therapy

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 of age
• 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
• Atrial fibrillation (AF) ablation surgery if combined with other cardiac procedures.
• Atrial septal defect (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
• Age ≥ 75 years

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
• 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 Heart Pump, 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
• Patients currently treated with chemotherapy or radiation therapy that may have an impact on kidney function.

Sponsors & Collaborators

• CardioRenal Systems, Inc.: lead

Study Sites (8)

Jessa Medica Center

Hasselt, Belgium

Location

TUM Klinikum Deutsches Herzzentrum

Munich, Germany

Location

Uniklinikum Munster

Münster, Germany

Location

Rambam Medical Center

Haifa, Israel

Location

Rabin Medical Center - Belinson Campus

Petah Tikva, Israel

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

Location

Hospital Universitario Ramón y Cajal

Madrid, Spain

Location

Sahlgrenska University Hospital

Gothenburg, Sweden

Location

Related Publications (2)

• Luckraz H, Giri R, Wrigley B, Nagarajan K, Senanayake E, Sharman E, Beare L, Nevill A. Balanced forced-diuresis as a renal protective approach in cardiac surgery: Secondary outcomes of electrolyte changes. J Card Surg. 2021 Nov;36(11):4125-4131. doi: 10.1111/jocs.15925. Epub 2021 Aug 19.

  PMID: 34414606 BACKGROUND

• 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

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

• Jacob Raphael, MD

  Thomas Jefferson University Hospitals

  PRINCIPAL INVESTIGATOR

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: January 22, 2025
• First Posted: February 6, 2025
• Study Start: February 23, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): April 30, 2028
• Last Updated: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

BE (1); ES (2); SE (1); IL (2); DE (2)