Study to Evaluate the Use of RenalGuard to Protect Patients at High Risk of AKI

NCT02793661 | Unknown

• 1 other identifier: REN-01
• Study Type: interventional
• Target: 300
• Locations: 2 countries
• Sites: 7

Brief Summary

The Strength study aim to evaluate the use of the RenalGuard device to protect the patients at high risk to develop acute kidney injury following a complex cardiovascular intervention requiring a high volume of contrast.

Conditions

Cardiovascular Disease; Acute Kidney Injury

Outcome Measures

Primary Outcomes (1)

• Occurence of contrast-induced nephropathy

  The occurence of contrast-induced nephropathy will be determined: * by an elevation, within 3 days from requiring contrast-procedure, of the serum creatinine (rise of 0.3mg/dl or of 25% compared to basal value) and/or * by the need for dialysis within 5 fays from requiring contrast-procedure

  Within 5 days

Secondary Outcomes (8)

• Change in serum creatinin value

  at 12 +-1 months

• Change in the estimated glomerular filtration rate

  at 12 +-1 months

• Percentage of patients on chronic dialysis

  at 12 +-1 months

• Percentage of patients on temporary dialysis

  at 12 +-1 months

• In hospital significant urinary bleeding, infection or any other major complication cause by the urinary catheter

  within 5 days from procedure

Study Arms (2)

RenalGuard Arm

EXPERIMENTAL

In order to prevent patients from acute kidney injury, patients will receive the RenalGuard Therapy delivered by the RenalGuard system from one hour before the cardiovascular intervention to 4 hours after the intervention.

Device: RenalGuard

Control Arm

ACTIVE COMPARATOR

Patient will received standard treatment, as per ESC Guidelines 2014, to prevent from acute kidney injury.

Other: Control

Interventions

RenalGuard DEVICE

Replacement of urine output by infusion of a matched volume of sterile replacement solution to maintain a patient's intravascular fluid volume. Diuretic is administered to reach an optimum urine flow and protect efficiently the patients' kidneys.

RenalGuard Arm

Control OTHER

Hydration protocol following ESC Guidelines 2014

Control Arm

Eligibility Criteria

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

You may qualify if:

• Age \> 18 years old
• ml/min/m2 ≤ eGFR ≤ 40 ml/min/m2
• High volume contrast-requiring cardiovascular procedures (estimated contrast volume \> 3 times eGFR value)
• Patient has agreed to all FU testing

You may not qualify if:

• Administration of iodine contrast media within 5 days before index procedure
• Emergency procedure or primary PCI
• Patients with pulmonary edema or cardiogenic shock (Killip 3 or 4)
• Hypoxemia defined as SaO2 ≤ 90% and/or PaO2 ≤ 80 mmHg on room air
• Acute Kidney Injury requiring dialysis before the procedure
• Multiple myeloma or cancer treated with chemotherapy
• Subjet is anuric
• Subject has been hospitalized for any change in renal function or has undergone renal replacement therapy (hemodialysis or hemofiltration) within the past month
• Known hypersensitivity to furosemide active ingredient or excipient
• Renal insufficiency with oligoanuria resistant to furosemide or caused by nephrotoxic or hepatotoxic substances
• Pre-coma or coma induced by an hepatic encephalopathy
• Severe hypokalemia, sever hyponatremia, hypovolemia with or without hypotension or dehydration
• Hypersensitivity to sulfamides
• Enrollment in another study unless the study is a registry or unless primary endpoint is reached
• Expected life expectancy \< 1 year

Sponsors & Collaborators

• European Cardiovascular Research Center: lead
• RenalGuard Solutions, Inc.: collaborator

Study Sites (7)

Hôpital Privé Jacques Cartier

Massy, 91300, France

RECRUITING

Hôpital Privé Claude Galien

Quincy-sous-Sénart, 91480, France

RECRUITING

CHU Rangueil

Toulouse, 31059, France

RECRUITING

Clinique Pasteur

Toulouse, 31076, France

RECRUITING

Universitätsklinikum Bonn

Bonn, 53105, Germany

NOT YET RECRUITING

Cardiovasculares Centrum Frankfurt

Frankfurt, 60389, Germany

RECRUITING

St Josefs Hospital

Wiesbaden, 65189, Germany

NOT YET RECRUITING

Related Publications (1)

• Hashimoto H, Yamada H, Murata M, Watanabe N. Diuretics for preventing and treating acute kidney injury. Cochrane Database Syst Rev. 2025 Jan 29;1(1):CD014937. doi: 10.1002/14651858.CD014937.pub2.

  PMID: 39878152 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases; Acute Kidney Injury

Condition Hierarchy (Ancestors)

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

Study Officials

• Andrew Halpert

  RenalGuard Solutions, Inc.

  STUDY DIRECTOR

Central Study Contacts

Jessica Heringer, PhD

CONTACT

+33 (0)1 76 73 92 16; jheringer@cerc-europe.org

Laure Morsiani, Ph D

CONTACT

+33 (0)1 76 73 92 36; lmorsiani@cerc-europe.org

Study Design

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

Study Record Dates

• First Submitted: June 3, 2016
• First Posted: June 8, 2016
• Study Start: May 1, 2016
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2018
• Last Updated: September 5, 2016

Record last verified: 2016-09

Locations

DE (3); FR (4)