Study to Evaluate the Use of RenalGuard to Protect Patients at High Risk of AKI
NCT ID: NCT02793661
Last Updated: 2016-09-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
300 participants
INTERVENTIONAL
2016-05-31
2018-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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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.
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.
Control Arm
Patient will received standard treatment, as per ESC Guidelines 2014, to prevent from acute kidney injury.
Control
Hydration protocol following ESC Guidelines 2014
Interventions
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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.
Control
Hydration protocol following ESC Guidelines 2014
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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RenalGuard Solutions, Inc.
INDUSTRY
European Cardiovascular Research Center
NETWORK
Responsible Party
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Principal Investigators
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Andrew Halpert
Role: STUDY_DIRECTOR
RenalGuard Solutions, Inc.
Locations
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Hôpital Privé Jacques Cartier
Massy, , France
Hôpital Privé Claude Galien
Quincy-sous-Sénart, , France
CHU Rangueil
Toulouse, , France
Clinique Pasteur
Toulouse, , France
Universitätsklinikum Bonn
Bonn, , Germany
Cardiovasculares Centrum Frankfurt
Frankfurt, , Germany
St Josefs Hospital
Wiesbaden, , Germany
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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REN-01
Identifier Type: -
Identifier Source: org_study_id
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