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

September 2, 2016 updated by: European Cardiovascular Research Center

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The Strength Trial is a randomized, international (France and Germany) and multicentre (7) trial.

The patients population targeted is suffering from kidney insufficiency (estimated Glomerular Filtration Rate (eGFR) between 15 to 40 ml/min/m2) need to go through a complex cardiovascular intervention..

This is a population of patients at high risk to develop AKI following contrast media administration and complex cardiovascular interventions require a high amount of contrast.

Standard treatment is hydration but with risk of hyper and hypohydration for this population of patients. RenalGuard insure the replacement of the urine output by infusion of a matched volume of sterile replacement solution to maintain patients' intravascular fluid volume.

The patients are randomized to be protected from contrast-induced nephropathy with the use of RenalGuard or by standard hydration treatment and will be followed-up during 12 months.

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Massy, France, 91300
        • Recruiting
        • Hôpital Privé Jacques Cartier
        • Principal Investigator:
          • Philippe Garot
        • Contact:
      • Quincy-sous-sénart, France, 91480
        • Recruiting
        • Hôpital Privé Claude Galien
        • Principal Investigator:
          • Philippe Garot
        • Contact:
      • Toulouse, France, 31059
      • Toulouse, France, 31076
  • Germany
      • Bonn, Germany, 53105
      • Frankfurt, Germany, 60389
      • Wiesbaden, Germany, 65189
        • Not yet recruiting
        • St Josefs Hospital
        • Contact:
        • Principal Investigator:
          • Horst Sievert, Prof

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age > 18 years old
  • 15 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

Exclusion Criteria:

  • 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
  • Pregnant or breastfeeding patient
  • Patient under trusteeship or guardianship
  • Patient is unable / unwilling to provide an informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: RenalGuard Arm
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
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.
Active Comparator: Control Arm
Patient will received standard treatment, as per ESC Guidelines 2014, to prevent from acute kidney injury.
Other: Control
Hydration protocol following ESC Guidelines 2014

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurence of contrast-induced nephropathy
Time Frame: Within 5 days

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in serum creatinin value
Time Frame: at 12 +-1 months
at 12 +-1 months
Change in the estimated glomerular filtration rate
Time Frame: at 12 +-1 months
at 12 +-1 months
Percentage of patients on chronic dialysis
Time Frame: at 12 +-1 months
at 12 +-1 months
Percentage of patients on temporary dialysis
Time Frame: at 12 +-1 months
at 12 +-1 months
In hospital significant urinary bleeding, infection or any other major complication cause by the urinary catheter
Time Frame: within 5 days from procedure
within 5 days from procedure
Composite of major adverse cardiovascular and cerebrovascular events (death, myocardial infarction, stroke, revascularization)
Time Frame: at 12 +-1 months
at 12 +-1 months
Individual MACCEs components (death, myocardial infarction, stroke, revascularization)
Time Frame: at 12 +-1 months
at 12 +-1 months
Economic evaluation of RenalGuard compared to standard renal protection according to ESC guidelines
Time Frame: Index hospitalization (including staged procedures) and 12+- 1 months
cost utility analysis
Index hospitalization (including staged procedures) and 12+- 1 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Cardiovascular Research Center

Collaborators

RenalGuard Solutions, Inc.

Investigators

  • Study Director: Andrew Halpert, RenalGuard Solutions, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Anticipated)

May 1, 2017

Study Completion (Anticipated)

May 1, 2018

Study Registration Dates

First Submitted

June 3, 2016

First Submitted That Met QC Criteria

June 3, 2016

First Posted (Estimate)

June 8, 2016

Study Record Updates

Last Update Posted (Estimate)

September 5, 2016

Last Update Submitted That Met QC Criteria

September 2, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REN-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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