Clinical trial NCT02793661: Study to Evaluate the Use of RenalGuard to Protect Patients at High Risk of AKI
Official title: Study to Evaluate the Use of RenalGuard to Protect Patients at High Risk of AKI (STRENGTH)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cardiovascular Disease
Acute Kidney Injury
Lead sponsor: European Cardiovascular Research Center
Sponsor class: NETWORK
Collaborators: name: RenalGuard Solutions, Inc.
First posted: 2016-06-08
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Occurence of contrast-induced nephropathy
timeFrame: Within 5 days
Secondary outcomes:
measure: Change in serum creatinin value
timeFrame: at 12 +-1 months
measure: Change in the estimated glomerular filtration rate
timeFrame: at 12 +-1 months
measure: Percentage of patients on chronic dialysis
timeFrame: at 12 +-1 months
measure: Percentage of patients on temporary dialysis
timeFrame: at 12 +-1 months
measure: In hospital significant urinary bleeding, infection or any other major complication cause by the urinary catheter
timeFrame: within 5 days from procedure
measure: Composite of major adverse cardiovascular and cerebrovascular events (death, myocardial infarction, stroke, revascularization)
timeFrame: at 12 +-1 months
measure: Individual MACCEs components (death, myocardial infarction, stroke, revascularization)
timeFrame: at 12 +-1 months
measure: Economic evaluation of RenalGuard compared to standard renal protection according to ESC guidelines
timeFrame: Index hospitalization (including staged procedures) and 12+- 1 months
Other outcomes:
Locations:
city: Massy
country: France
facility: Hôpital Privé Jacques Cartier
city: Quincy-sous-sénart
country: France
facility: Hôpital Privé Claude Galien
city: Toulouse
country: France
facility: CHU Rangueil
city: Toulouse
country: France
facility: Clinique Pasteur
city: Bonn
country: Germany
facility: Universitätsklinikum Bonn
city: Frankfurt
country: Germany
facility: Cardiovasculares Centrum Frankfurt
city: Wiesbaden
country: Germany
facility: St Josefs Hospital
Study officials:
affiliation: RenalGuard Solutions, Inc.
name: Andrew Halpert
role: STUDY_DIRECTOR
References: