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

Cardiovascular Disease Clinical Trial

— STRENGTH  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02793661
• Other study ID #: REN-01
• Status: Recruiting
• Phase: N/A
• First received: June 3, 2016
• Last updated: September 2, 2016
• Start date: May 2016
• Est. completion date: May 2018

Study information

• Verified date: September 2016
• Source: European Cardiovascular Research Center
• Contact: Jessica Heringer, PhD
• Phone: +33 (0)1 76 73 92 16
• Email: jheringer[@]cerc-europe.org
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santéGermany: Ethikkommission der Landesärztekammer Hessen
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: May 2018
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Acute Kidney Injury
• Cardiovascular Disease
• Cardiovascular Diseases

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.

Other:
• Control
Hydration protocol following ESC Guidelines 2014

Locations

Country	Name	City	State
France	Hôpital Privé Jacques Cartier	Massy
France	Hôpital Privé Claude Galien	Quincy-sous-sénart
France	CHU Rangueil	Toulouse
France	Clinique Pasteur	Toulouse
Germany	Universitätsklinikum Bonn	Bonn
Germany	Cardiovasculares Centrum Frankfurt	Frankfurt
Germany	St Josefs Hospital	Wiesbaden

Sponsors (2)

Lead Sponsor	Collaborator
European Cardiovascular Research Center	RenalGuard Solutions, Inc.

Countries where clinical trial is conducted

France,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Change in serum creatinin value		at 12 +-1 months	Yes
Secondary	Change in the estimated glomerular filtration rate		at 12 +-1 months	Yes
Secondary	Percentage of patients on chronic dialysis		at 12 +-1 months	Yes
Secondary	Percentage of patients on temporary dialysis		at 12 +-1 months	Yes
Secondary	In hospital significant urinary bleeding, infection or any other major complication cause by the urinary catheter		within 5 days from procedure	Yes
Secondary	Composite of major adverse cardiovascular and cerebrovascular events (death, myocardial infarction, stroke, revascularization)		at 12 +-1 months	Yes
Secondary	Individual MACCEs components (death, myocardial infarction, stroke, revascularization)		at 12 +-1 months	Yes
Secondary	Economic evaluation of RenalGuard compared to standard renal protection according to ESC guidelines	cost utility analysis	Index hospitalization (including staged procedures) and 12+- 1 months	No