Acute Kidney InjuryNCT01936142
The Use of Renal Guard System in Patients Undergoing CRT Implantation
A study testing Use of RenalGuard in people with Acute Kidney Injury, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
The purpose of this study is to determine whether the use of RenalGuard system which creates high urine output with fluid balancing may prevent contrast induced nephropathy in patient undergoing cardiac resynchronization therapy (CRT) implantation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- Use of RenalGuard
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2013to Sep 2014
- 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
- eligible for CRT implantation
- estimated GFR < 60ml/min/1.73m2
Who cannot join
- On Dialysis
- Sensitivity to Furosemide
- Contraindication for urinary catheter
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Forced Diuresis With Matched Hydration in Reducing Acute Kidney Injury During CRT Implantation
The purpose of this study is to determine whether the use of RenalGuard system which creates high urine output with fluid balancing may prevent contrast induced nephropathy in patient undergoing cardiac resynchronization therapy (CRT) implantation.
- Conditions
- Acute Kidney Injury
- Being tested
- Use of RenalGuard
- Keywords
- Resynchroniztion therapy, Kidney, Contrast media, Prevention
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of RenalGuardDevice
| Study group | Role | What they receive |
|---|---|---|
| No RenalGuard | No intervention | Control group will undergo CRT implantation without using RenalGuard |
| RenalGuard | Experimental | Use of the RenalGuard system during CRT implantation Receives: Device: Use of RenalGuard |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Renal function
Change in Renal function will be measured by change in serum creatinine (mg/dl)
Measured: 24 and 48 hours post implantation and 8-11 days post implantation, 6 month post implantaion
Secondary outcomes (1)
Left ventricular lead implantation success
Measured: 1 day post implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2013 (estimated)
- Study startSep 2013
- Primary completionJun 2014
- Study completionSep 2014
Why it stopped: No suitable patient found
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, michal roll, Tel-Aviv Sourasky Medical Center
- Investigators
- Yoav Michowich, MD, Principal investigator, Tel Aviv Sourasky MC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01936142
- Sponsor's protocol ID
- TASMC-13-0167-YMICH
- Status last verified
- Jul 2016
- First submitted
- 22 Aug 2013
- Last updated
- 7 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Forced Diuresis With Matched Hydration in Reducing Acute Kidney Injury During CRT Implantation
- ClinicalTrials.gov ID
- NCT01936142
- Acronym / sponsor ID
- TASMC-13-0167-YMICH
- Conditions
- Acute Kidney Injury
- Keywords
- Resynchroniztion therapy, Kidney, Contrast media, Prevention
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No suitable patient found
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Sep 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 5 Sep 2013 (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 purpose of this study is to determine whether the use of RenalGuard system which creates high urine output with fluid balancing may prevent contrast induced nephropathy in patient undergoing cardiac resynchronization therapy (CRT) implantation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No RenalGuard | No intervention | –Control group will undergo CRT implantation without using RenalGuard |
| RenalGuard | Experimental | Device: Use of RenalGuardUse of the RenalGuard system during CRT implantation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- eligible for CRT implantation
- estimated GFR < 60ml/min/1.73m2
Key exclusion criteria (4 listed)
- On Dialysis
- Sensitivity to Furosemide
- Contraindication for urinary catheter
- Pregnancy
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 |
|---|---|---|
| Use of RenalGuard | Device | RenalGuard |
Primary outcome
Change in Renal function
Time frame: 24 and 48 hours post implantation and 8-11 days post implantation, 6 month post implantaion
Change in Renal function will be measured by change in serum creatinine (mg/dl)
1 secondary outcome
Left ventricular lead implantation success
Time frame: 1 day post implantation
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2016.
- Individual participant dataSharing planned: No
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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.
Yoav Michowich, MD principal investigator
Tel Aviv Sourasky MC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Use of RenalGuard in people with Acute Kidney Injury, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
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 2 inclusion and 4 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: withdrawn, as of the sponsor's last update on 7 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Renal function (time frame: 24 and 48 hours post implantation and 8-11 days post implantation, 6 month post implantaion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Jul 2016.