Impaired Renal FunctionRenProLongNCT01760031
Longterm Follow-up After Remote Ischemic Preconditioning for Prevention of Contrast-induced Nephropathy
An observational study of Impaired Renal Function, run by University of Cologne at 1 site in Germany.
Trial summary
Remote ischemic preconditioning reduces the incidence of contrast-induced acute kidney injury in patients undergoing elective coronary angiography. This study was designed to acquire long-term data of initially randomized patients in the RenPro Trial. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Impaired Renal Function
- What is being tested?
- Ischemic preconditioning
- How many people
- 81 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2012to Jan 2013
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients refered for elective cardiac catherization to the university hospital of Cologne. All patients who participated to the RenPro trial (www.germanctr.de; DRKS-ID DRKS00000666)
All patients who participated to the RenPro trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Remote Preconditioning for Contrast-Induced Acute Kidney Injury: Long-Term Follow up (RenPro Longterm)
Remote ischemic preconditioning reduces the incidence of contrast-induced acute kidney injury in patients undergoing elective coronary angiography. This study was designed to acquire long-term data of initially randomized patients in the RenPro Trial.
Read the detailed description
Data of the RenPro Trial has been already published. In the present study data of longterm follow up are collected.
- Conditions
- Impaired Renal Function
- Being tested
- Ischemic preconditioning
- Keywords
- preconditioning, contrast-induced acute kidney injury, renal faliure
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ischemic preconditioningOther
Subjects received ischemic preconditioning previous to cardiac catheterization
| Study group | Role | What they receive |
|---|---|---|
| Subjects with impaired renal function | Subjects with baseline impaired renal function undergoing cardiac catheterization with contrast-medium exposure Receives: Other: Ischemic preconditioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
MACCE
Major Adverse Cardiac and Cerebrovascular Events (Combined primary endpoint):
All-cause mortality, cardiovascular mortality, rehospitalization, stroke, myocardial infarction, hemodialysis
Measured: 1 Year
Secondary outcomes (1)
Renal function
changes of serum creatinine, eGFR, NGAL and cystatin C compared to baseline in both groups.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2013 (estimated)
- Study startJul 2012
- Primary completionDec 2012
- Study completionJan 2013 (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 Impaired 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 81 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cologne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Fikret Er, University of Cologne
- Investigators
- Fikret Er, MD, Principal investigator, University Hospital of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01760031
- Sponsor's protocol ID
- RenPro1L
- Acronym
- RenProLong
- Status last verified
- Dec 2012
- First submitted
- 28 Dec 2012
- Last updated
- 3 Jan 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 22735306
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Preconditioning for Contrast-Induced Acute Kidney Injury: Long-Term Follow up (RenPro Longterm)
- ClinicalTrials.gov ID
- NCT01760031
- Acronym / sponsor ID
- RenProLong / RenPro1L
- Conditions
- Impaired Renal Function
- Keywords
- preconditioning, contrast-induced acute kidney injury, renal faliure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 81 participants (estimated)
- Lead sponsor
- University of CologneUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Jan 2013 (estimated)
- First posted
- 3 Jan 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.
Remote ischemic preconditioning reduces the incidence of contrast-induced acute kidney injury in patients undergoing elective coronary angiography. This study was designed to acquire long-term data of initially randomized patients in the RenPro Trial.
Detailed description
Data of the RenPro Trial has been already published. In the present study data of longterm follow up are collected.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects with impaired renal function | – | Other: Ischemic preconditioningSubjects with baseline impaired renal function undergoing cardiac catheterization with contrast-medium exposure |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients refered for elective cardiac catherization to the university hospital of Cologne. All patients who participated to the RenPro trial (www.germanctr.de; DRKS-ID DRKS00000666)
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 |
|---|---|---|
| Ischemic preconditioningSubjects received ischemic preconditioning previous to cardiac catheterization | Other | Subjects with impaired renal function |
Primary outcome
MACCE
Time frame: 1 Year
Major Adverse Cardiac and Cerebrovascular Events (Combined primary endpoint): All-cause mortality, cardiovascular mortality, rehospitalization, stroke, myocardial infarction, hemodialysis
1 secondary outcome
Renal function
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2013.
- Results publication: 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.
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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.
Fikret Er, MD principal investigator
University Hospital of Cologne
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 Impaired Renal Function, 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?
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 3 Jan 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?
Results are not available in the source record.
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?
MACCE (time frame: 1 Year). 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 NCT01760031, 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 3 Jan 2013.