Cardiovascular DiseaseSTRENGTHNCT02793661
Study to Evaluate the Use of RenalGuard to Protect Patients at High Risk of AKI
A study testing RenalGuard in people with Cardiovascular Disease and Acute Kidney Injury, run by European Cardiovascular Research Center at 7 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Disease, Acute Kidney Injury
- What is being tested?
- RenalGuard
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 7 sitesin 2 countries
- Study dates
- May 2016to May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
France4 sites, 4 recruiting
- Recruiting
Hôpital Privé Jacques Cartier
Massy, 91300
Philippe Garot, +33160134602, pgarot@angio-icps.com
Philippe Garot
- Recruiting
Hôpital Privé Claude Galien
Quincy-sous-Sénart, 91480
Philippe Garot, +33169399169, pgarot@angio-icps.com
Philippe Garot
- Recruiting
CHU Rangueil
Toulouse, 31059
Didier Carrié, carrie.didier@chu-toulouse.fr
Didier Carrié
- Recruiting
Clinique Pasteur
Toulouse, 31076
Jean Fajadet, jfajadet@clinique-pasteur.com
Jean Fajadet
Germany3 sites, 3 recruiting
- Not yet recruiting
Universitätsklinikum Bonn
Bonn, 53105
Georg Nickenig, georg.nickenig@ukb.uni-bonn.de
Georg Nickenig
- Recruiting
Cardiovasculares Centrum Frankfurt
Frankfurt, 60389
Horst Sievert, horstsievertmd@aol.com
Horst Sievert
- Not yet recruiting
St Josefs Hospital
Wiesbaden, 65189
Horst Sievert, Prof, horstsievertmd@aol.com
Horst Sievert, Prof
About this study
Official title: 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.
Read the 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.
- Conditions
- Cardiovascular Disease, Acute Kidney Injury
- Being tested
- RenalGuard, Control
- Medical subject headings
- Cardiovascular Diseases, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RenalGuardDevice
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.
ControlOther
Hydration protocol following ESC Guidelines 2014
| Study group | Role | What they receive |
|---|---|---|
| RenalGuard Arm | Experimental | 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. Receives: Device: RenalGuard |
| Control Arm | Active comparator | Patient will received standard treatment, as per ESC Guidelines 2014, to prevent from acute kidney injury. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Within 5 days
Secondary outcomes (8)
Change in serum creatinin value
Measured: at 12 +-1 months
Change in the estimated glomerular filtration rate
Measured: at 12 +-1 months
Percentage of patients on chronic dialysis
Measured: at 12 +-1 months
Percentage of patients on temporary dialysis
Measured: at 12 +-1 months
In hospital significant urinary bleeding, infection or any other major complication cause by the urinary catheter
Measured: within 5 days from procedure
Composite of major adverse cardiovascular and cerebrovascular events (death, myocardial infarction, stroke, revascularization)
Measured: at 12 +-1 months
Individual MACCEs components (death, myocardial infarction, stroke, revascularization)
Measured: at 12 +-1 months
Economic evaluation of RenalGuard compared to standard renal protection according to ESC guidelines
cost utility analysis
Measured: Index hospitalization (including staged procedures) and 12+- 1 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2016 (estimated)
- Study startMay 2016
- Primary completionMay 2017 (estimated)
- Study completionMay 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- European Cardiovascular Research Center
- Sponsor type
- Research network
- Collaborators
- RenalGuard Solutions, Inc.
- Responsible party
- Sponsor
- Investigators
- Andrew Halpert, Study director, RenalGuard Solutions, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02793661
- Sponsor's protocol ID
- REN-01
- Acronym
- STRENGTH
- Status last verified
- Sep 2016
- First submitted
- 3 Jun 2016
- Last updated
- 5 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 39878152
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Evaluate the Use of RenalGuard to Protect Patients at High Risk of AKI (STRENGTH)
- ClinicalTrials.gov ID
- NCT02793661
- Acronym / sponsor ID
- STRENGTH / REN-01
- Conditions
- Cardiovascular Disease, Acute Kidney Injury
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- European Cardiovascular Research CenterResearch network
- Collaborators
- RenalGuard Solutions, Inc.
- Study start
- May 2016
- Primary completion
- May 2017 (estimated)
- Study completion
- May 2018 (estimated)
- First posted
- 8 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RenalGuard Arm | Experimental | Device: RenalGuardIn 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. |
| Control Arm | Active comparator | Other: ControlPatient will received standard treatment, as per ESC Guidelines 2014, to prevent from acute kidney injury. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RenalGuardReplacement 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. | Device | RenalGuard Arm |
| ControlHydration protocol following ESC Guidelines 2014 | Other | Control Arm |
Primary outcome
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
8 secondary outcomes
Change in serum creatinin value
Time frame: at 12 +-1 months
Change in the estimated glomerular filtration rate
Time frame: at 12 +-1 months
Percentage of patients on chronic dialysis
Time frame: at 12 +-1 months
Percentage of patients on temporary dialysis
Time frame: 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
Composite of major adverse cardiovascular and cerebrovascular events (death, myocardial infarction, stroke, revascularization)
Time frame: at 12 +-1 months
Individual MACCEs components (death, myocardial infarction, stroke, revascularization)
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2016.
- Derived from this study: PubMed 39878152Hashimoto 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Halpert study director
RenalGuard Solutions, Inc.
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RenalGuard in people with Cardiovascular Disease and Acute Kidney Injury, run by European Cardiovascular Research Center at 7 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jessica Heringer, PhD (+33 (0)1 76 73 92 16, jheringer@cerc-europe.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurence of contrast-induced nephropathy (time frame: Within 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02793661, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2016.