- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01827891
Remote Ischemic Preconditioning and Risk of Contrast-Induced Acute Kidney Injury in Patients Undergoing Coronary Stent Implantation (REPAIR)
April 9, 2013 updated by: Yujie Zhou, Beijing Anzhen Hospital
This single-center, randomized controlled trial is to investigate the impact of remote ischemic preconditioning (RIPC) on the risk contrast-induced acute kidney injury and its long-term impact on renal function for patients with diabetes undergoing percutaneous coronary intervention.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
Patients with diabetes undergoing elective percutaneous coronary intervention in Beijing Anzhen Hospital were enrolled, and all the eligible participants were randomized to either remote ischemic preconditioning (RIPC) group or control group.
Those randomized to RIPC group had a pneumatic medical tourniquet cuff (width , 5 cm ; length , 40 cm) placed around their upper arm at < 2 hours before the PCI procedure.
The pneumatic medical cuff was inflated to a pressure of 200 mm Hg for 5 minutes , followed by 5 minutes of deflation to allow reperfusion.
This procedure was repeated for 3 times.
Control participants did not experience this procedure of transient upper-limb ischemia.
Study Type
Interventional
Enrollment (Actual)
310
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Beijing, China, 100029
- Beijing Anzhen Hospital, Capital Medical University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients with diabetes undergoing percutaneous coronary intervention were included.
Exclusion Criteria:
- emergency PCI,
- baseline troponin value > 0.04 ng/mL,
- nicorandil or glibenclamide use (preconditioning-mimetic and preconditioning-blocking medication, respectively),
- patient on dialysis,
- patients who had some inability to cooperate with the trial,
- those who could not give informed consent, and (7) second procedure of staged elective PCI in this hospitalization.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: control group
Control participants did not experience the procedure of transient upper-limb ischemia.
|
|
Active Comparator: remote ischemic preconditioning (RIPC) group
Those randomized to RIPC group had a pneumatic medical tourniquet cuff (width , 5 cm ; length , 40 cm) placed around their upper arm at < 2 hours before the PCI procedure.
The pneumatic medical cuff was inflated to a pressure of 200 mm Hg for 5 minutes , followed by 5 minutes of deflation to allow reperfusion.
This procedure was repeated for 3 times.
|
Those randomized to RIPC group had a pneumatic medical tourniquet cuff (width , 5 cm ; length , 40 cm) placed around their upper arm at < 2 hours before the PCI procedure.
The pneumatic medical cuff was inflated to a pressure of 200 mm Hg for 5 minutes , followed by 5 minutes of deflation to allow reperfusion.
This procedure was repeated for 3 times.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
acute kidney injury
Time Frame: 72 hours after procedure
|
The primary study endpoint was AKI, defined as an absolute rise in serum creatinine of ≥ 0.5 mg/dl or a relative increase of ≥ 25% compared to baseline within 72 hours from PCI (the maximal measured concentration of serum creatinine during these 72 hours was used).
|
72 hours after procedure
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
relative reduction in estimated glomerular filtration rate
Time Frame: 180 days after procedure
|
Secondary endpoints were the relative reduction in estimated glomerular filtration rate (eGFR) as well as all cause mortality, myocardial infarction and stent thrombosis at 30-day and 180-day after procedure.
|
180 days after procedure
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2012
Primary Completion (Actual)
January 1, 2013
Study Completion (Anticipated)
June 1, 2013
Study Registration Dates
First Submitted
March 31, 2013
First Submitted That Met QC Criteria
April 9, 2013
First Posted (Estimate)
April 10, 2013
Study Record Updates
Last Update Posted (Estimate)
April 10, 2013
Last Update Submitted That Met QC Criteria
April 9, 2013
Last Verified
April 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AZ-12
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Acute Kidney Injury
-
Instituto Nacional de Cardiologia Ignacio ChavezInstituto Nacional de Ciencias Medicas y Nutricion Salvador ZubiranUnknownKidney Injury, Acute | Acute Renal Injury | Acute Kidney Injuries | Kidney Injuries, Acute | Acute Renal InjuriesMexico
-
Yonsei UniversityCompletedAcute Kidney Injury(Postoperative Acute Kidney Injury in Patients Undergoing Aortic Surgery)Korea, Republic of
-
University Hospital, GhentWithdrawn
-
Beni-Suef UniversityCairo UniversityRecruitingAKI - Acute Kidney InjuryEgypt
-
University Hospital MuensterBaxter Healthcare CorporationCompletedAcute Kidney Injury (AKI)Spain, France, United States, Turkey, Germany, Egypt, Italy, Libyan Arab Jamahiriya, Malta, North Macedonia, Palestinian Territory, occupied, Russian Federation, Saudi Arabia, Slovenia
-
Chinese PLA General HospitalBeijing Tsinghua Changgeng HospitalCompletedPostoperative Acute Kidney InjuryChina
-
Chinese PLA General HospitalCompletedPostoperative Acute Kidney InjuryChina
-
Ain Shams UniversityRecruiting
-
Astellas Pharma IncCompleted
-
South Egypt Cancer InstituteCompletedAcute Kidney Injury (AKI)Egypt
Clinical Trials on remote ischemic preconditioning (RIPC)
-
Medical University of LodzCompletedRemote Ischemic Preconditioning | Contrast Induced - Acute Kidney InjuryPoland
-
Institut für Pharmakologie und Präventive MedizinWithdrawnEffectivity of RIPC in Outcomes of TAVI ProcedureGermany
-
Xijing HospitalUnknownCardiac Surgery PatientsChina
-
Beijing Tiantan HospitalPeking University International HospitalSuspendedMoyamoya Disease | Remote Ischemic PreconditioningChina
-
VA Office of Research and DevelopmentRecruitingHeart Failure | Acute Kidney Injury | Percutaneous Coronary Intervention | Contrast Induced Nephropathy | Coronary AngiographyUnited States
-
Westfälische Wilhelms-Universität MünsterRecruitingSepsis | Acute Kidney Injury | Critically IllGermany
-
University Hospital MuensterElse Kröner Fresenius FoundationUnknownCardiac Surgery, Aortocoronary BypassGermany
-
Ji XunmingCompletedCarotid Artery StenosisChina
-
Seoul National University HospitalRecruitingIschemic Reperfusion Injury | Radiotherapy | Other Reconstructive SurgeryKorea, Republic of