Renal FunctionRenPRO-TAVINCT01925235
Analysis of Remote-ischemic Preconditioning Effects on Kidney Function
An observational study of Renal Function and Renal Injury, run by University of Cologne at 1 site in Germany.
Trial summary
Patients with impaired renal function are at elevated risk for development of acute kidney injury (AKI). AKI is associated with increased risk for cardiovascular morbidity and mortality. Effective AKI prevention strategies are needed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Function, Renal Injury
- What is being tested?
- remote ischemic preconditioning
- Type of treatment
- Surgery or procedure
- How many people
- 18 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2010to Jul 2011
- Phase
- Observational
- 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
Study population: patients with impaired renal function and a high risk of developing contrast medium-induced acute kidney injury undergoing TAVI
Who may be able to join
- age >= 18 years
- impaired renal function (baseline eGFR of <60 ml/min)
- high INTEGER risk score > 11
- high EuroSCORE (European system for cardiac operative risk evaluation)
Who cannot join
- severe renal impairment (eGFR <15 ml/min and/or in chronic dialysis)
- recent (<=30 days) contrast media exposure
- patients enrolled in concomitant studies
- fertile women
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital of Cologne
Cologne, North Rhine-Westphalia, 50931
About this study
Official title: Remote Ischemic Preconditioning Effects on Kidney Function in Patients Receiving Transcatheter Aortic Valve Implantation
Patients with impaired renal function are at elevated risk for development of acute kidney injury (AKI). AKI is associated with increased risk for cardiovascular morbidity and mortality. Effective AKI prevention strategies are needed. Remote ischemic preconditioning (RIPC) is a novel and successful strategy to attenuate contrast medium induced AKI in patients undergoing elective coronary angiography.
The retrospective RenPro-TAVI Trial was designed to test the hypothesis whether remote ischemic preconditioning might attenuate kidney injury in patients receiving transcatheter aortic valve implantation (TAVI).
Patients with impaired renal function undergoing TAVI will be evaluated in respect whether they received remote ischemic preconditioning before the procedure or not. This study will give insight if RIPC might be beneficial in these patients.
- Conditions
- Renal Function, Renal Injury
- Being tested
- remote ischemic preconditioning
- Keywords
- remote ischemic preconditioning, acute kidney injury, TAVI, RenPRO trial, parameters
- 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.
remote ischemic preconditioningProcedure or surgery
Also called intermittent arm ischemia through 4 cycles of 5-minute inflation and 5-minute deflation of a blood pressure cuff
| Study group | Role | What they receive |
|---|---|---|
| Control | patients with impaired renal function and a high risk of developing acute kidney injury undergoing TAVI and receiving standard care including pre-hydration 12 hours prior and 12 hours post procedure | |
| RIPC | patients with impaired renal function and a high risk of developing acute kidney injury undergoing TAVI and receiving standard care including pre-hydration 12 hours prior and 12 hours post procedure plus ischemic preconditioning (intermittent arm ischemia through 4 cycles of 5-minute inflation and 5-minute deflation of a blood pressure cuff) Receives: Procedure: remote ischemic preconditioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in parameters determining renal function and injury
serum creatinine, cystatin c, urinary neutrophil gelatinase-associated lipocalin (NGAL)
Measured: 48 hours after TAVI
Secondary outcomes (1)
acute kidney injury
increase in serum creatinine ≥25% or ≥0.5 mg/dL above baseline at 48 hours after TAVI
Measured: 48 hours after TAVI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2013 (estimated)
- Study startMar 2010
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Renal FunctionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cologne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Fikret Er, University of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01925235
- Sponsor's protocol ID
- Ren-PRO TAVI retro
- Acronym
- RenPRO-TAVI
- Status last verified
- Aug 2013
- First submitted
- 15 Aug 2013
- Last updated
- 19 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Er F, Nia AM, Dopp H, Hellmich M, Dahlem KM, Caglayan E, Kubacki T, Benzing T, Erdmann E, Burst V, Gassanov N. Ischemic preconditioning for prevention of contrast medium-induced nephropathy: randomized pilot RenPro Trial (Renal Protection Trial). Circulation. 2012 Jul 17;126(3):296-303. doi: 10.1161/CIRCULATIONAHA.112.096370. Epub 2012 Jun 26.
PubMed 22735306Er F, Nia AM, Dopp H, Dahlem KM, Caglayan E, Erdmann E, Gassanov N, Hellmich M, Burst V, Kubacki T, Benzing T. Response to letter regarding article, "Ischemic preconditioning for prevention of contrast medium-induced nephropathy: randomized Pilot RenPro-Trial (Renal Protection Trial)". Circulation. 2013 Apr 2;127(13):e536. doi: 10.1161/circulationaha.112.147587. No abstract available.
PubMed 23662313
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Ischemic Preconditioning Effects on Kidney Function in Patients Receiving Transcatheter Aortic Valve Implantation
- ClinicalTrials.gov ID
- NCT01925235
- Acronym / sponsor ID
- RenPRO-TAVI / Ren-PRO TAVI retro
- Conditions
- Renal Function, Renal Injury
- Keywords
- remote ischemic preconditioning, acute kidney injury, TAVI, RenPRO trial, parameters
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of CologneUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 19 Aug 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.
Patients with impaired renal function are at elevated risk for development of acute kidney injury (AKI). AKI is associated with increased risk for cardiovascular morbidity and mortality. Effective AKI prevention strategies are needed. Remote ischemic preconditioning (RIPC) is a novel and successful strategy to attenuate contrast medium induced AKI in patients undergoing elective coronary angiography.
The retrospective RenPro-TAVI Trial was designed to test the hypothesis whether remote ischemic preconditioning might attenuate kidney injury in patients receiving transcatheter aortic valve implantation (TAVI).
Patients with impaired renal function undergoing TAVI will be evaluated in respect whether they received remote ischemic preconditioning before the procedure or not. This study will give insight if RIPC might be beneficial in these patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | – | –patients with impaired renal function and a high risk of developing acute kidney injury undergoing TAVI and receiving standard care including pre-hydration 12 hours prior and 12 hours post procedure |
| RIPC | – | Procedure: remote ischemic preconditioningpatients with impaired renal function and a high risk of developing acute kidney injury undergoing TAVI and receiving standard care including pre-hydration 12 hours prior and 12 hours post procedure plus ischemic preconditioning (intermittent arm ischemia through 4 cycles of 5-minute inflation and 5-minute deflation of a blood pressure cuff) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with impaired renal function and a high risk of developing contrast medium-induced acute kidney injury undergoing TAVI
Key inclusion criteria (4 listed)
- age >= 18 years
- impaired renal function (baseline eGFR of <60 ml/min)
- high INTEGER risk score > 11
- high EuroSCORE (European system for cardiac operative risk evaluation)
Key exclusion criteria (4 listed)
- severe renal impairment (eGFR <15 ml/min and/or in chronic dialysis)
- recent (<=30 days) contrast media exposure
- patients enrolled in concomitant studies
- fertile women
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 |
|---|---|---|
| remote ischemic preconditioningAlso: intermittent arm ischemia through 4 cycles of 5-minute inflation and 5-minute deflation of a blood pressure cuff | Procedure or surgery | RIPC |
Primary outcome
change in parameters determining renal function and injury
Time frame: 48 hours after TAVI
serum creatinine, cystatin c, urinary neutrophil gelatinase-associated lipocalin (NGAL)
1 secondary outcome
acute kidney injury
Time frame: 48 hours after TAVI
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2013.
- Background: PubMed 22735306Er F, Nia AM, Dopp H, Hellmich M, Dahlem KM, Caglayan E, Kubacki T, Benzing T, Erdmann E, Burst V, Gassanov N. Ischemic preconditioning for prevention of contrast medium-induced nephropathy: randomized pilot RenPro Trial (Renal Protection Trial). Circulation. 2012 Jul 17;126(3):296-303. doi: 10.1161/CIRCULATIONAHA.112.096370. Epub 2012 Jun 26.
- Background: PubMed 23662313Er F, Nia AM, Dopp H, Dahlem KM, Caglayan E, Erdmann E, Gassanov N, Hellmich M, Burst V, Kubacki T, Benzing T. Response to letter regarding article, "Ischemic preconditioning for prevention of contrast medium-induced nephropathy: randomized Pilot RenPro-Trial (Renal Protection Trial)". Circulation. 2013 Apr 2;127(13):e536. doi: 10.1161/circulationaha.112.147587. No abstract available.
- Related InfoLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Function and Renal Injury, run by University of Cologne at 1 site in Germany.
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 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: finished, as of the sponsor's last update on 19 Aug 2013. 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 parameters determining renal function and injury (time frame: 48 hours after TAVI). 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 NCT01925235, which also lists 2 linked publications.
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 19 Aug 2013.