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

Primary Purpose

Cardiovascular Disease, Acute Kidney Injury

Status

Unknown status

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

RenalGuard

Control

About this trial

This is an interventional prevention trial for Cardiovascular Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Hôpital Privé Jacques CartierRecruiting
Hôpital Privé Claude GalienRecruiting
CHU RangueilRecruiting
Clinique PasteurRecruiting
Universitätsklinikum Bonn
Cardiovasculares Centrum FrankfurtRecruiting
St Josefs Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

RenalGuard Arm

Control Arm

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in serum creatinin value

Change in the estimated glomerular filtration rate

Percentage of patients on chronic dialysis

Percentage of patients on temporary dialysis

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

Composite of major adverse cardiovascular and cerebrovascular events (death, myocardial infarction, stroke, revascularization)

Individual MACCEs components (death, myocardial infarction, stroke, revascularization)

Economic evaluation of RenalGuard compared to standard renal protection according to ESC guidelines

cost utility analysis

Full Information

NCT ID

NCT02793661

First Posted

June 3, 2016

Last Updated

September 2, 2016

Sponsor

European Cardiovascular Research Center

Collaborators

RenalGuard Solutions, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02793661

Brief Title

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

Acronym

STRENGTH

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2016

Overall Recruitment Status

Unknown status

Study Start Date

May 2016 (undefined)

Primary Completion Date

May 2017 (Anticipated)

Study Completion Date

May 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

European Cardiovascular Research Center

Collaborators

RenalGuard Solutions, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cardiovascular Disease, Acute Kidney Injury

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

RenalGuard Arm

Arm Type

Experimental

Arm Description

Arm Title

Control Arm

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

RenalGuard

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Control

Intervention Description

Hydration protocol following ESC Guidelines 2014

Primary Outcome Measure Information:

Title

Occurence of contrast-induced nephropathy

Description

Time Frame

Within 5 days

Secondary Outcome Measure Information:

Title

Change in serum creatinin value

Time Frame

at 12 +-1 months

Title

Change in the estimated glomerular filtration rate

Time Frame

at 12 +-1 months

Title

Percentage of patients on chronic dialysis

Time Frame

at 12 +-1 months

Title

Percentage of patients on temporary dialysis

Time Frame

at 12 +-1 months

Title

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

Time Frame

within 5 days from procedure

Title

Composite of major adverse cardiovascular and cerebrovascular events (death, myocardial infarction, stroke, revascularization)

Time Frame

at 12 +-1 months

Title

Individual MACCEs components (death, myocardial infarction, stroke, revascularization)

Time Frame

at 12 +-1 months

Title

Economic evaluation of RenalGuard compared to standard renal protection according to ESC guidelines

Description

cost utility analysis

Time Frame

Index hospitalization (including staged procedures) and 12+- 1 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jessica Heringer, PhD

Phone

+33 (0)1 76 73 92 16

jheringer@cerc-europe.org

First Name & Middle Initial & Last Name or Official Title & Degree

Laure Morsiani, Ph D

Phone

+33 (0)1 76 73 92 36

lmorsiani@cerc-europe.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Andrew Halpert

Organizational Affiliation

RenalGuard Solutions, Inc.

Official's Role

Study Director

Facility Information:

Facility Name

Hôpital Privé Jacques Cartier

City

Massy

ZIP/Postal Code

91300

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Philippe Garot

Phone

+33160134602

pgarot@angio-icps.com

First Name & Middle Initial & Last Name & Degree

Philippe Garot

Facility Name

Hôpital Privé Claude Galien

City

Quincy-sous-sénart

ZIP/Postal Code

91480

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Philippe Garot

Phone

+33169399169

pgarot@angio-icps.com

First Name & Middle Initial & Last Name & Degree

Philippe Garot

Facility Name

CHU Rangueil

City

Toulouse

ZIP/Postal Code

31059

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Didier Carrié

carrie.didier@chu-toulouse.fr

First Name & Middle Initial & Last Name & Degree

Didier Carrié

Facility Name

Clinique Pasteur

City

Toulouse

ZIP/Postal Code

31076

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jean Fajadet

jfajadet@clinique-pasteur.com

First Name & Middle Initial & Last Name & Degree

Jean Fajadet

Facility Name

Universitätsklinikum Bonn

City

Bonn

ZIP/Postal Code

53105

Country

Germany

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Georg Nickenig

georg.nickenig@ukb.uni-bonn.de

First Name & Middle Initial & Last Name & Degree

Georg Nickenig

Facility Name

Cardiovasculares Centrum Frankfurt

City

Frankfurt

ZIP/Postal Code

60389

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Horst Sievert

horstsievertmd@aol.com

First Name & Middle Initial & Last Name & Degree

Horst Sievert

Facility Name

St Josefs Hospital

City

Wiesbaden

ZIP/Postal Code

65189

Country

Germany

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Horst Sievert, Prof

horstsievertmd@aol.com

First Name & Middle Initial & Last Name & Degree

Horst Sievert, Prof

12. IPD Sharing Statement

Learn more about this trial

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

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