RIPCIN study: Remote Ischemic Preconditioning to reduce Contrast-Induced Nephropathy

ISRCTN ISRCTN76496973
DOI https://doi.org/10.1186/ISRCTN76496973
Secondary identifying numbers N/A
Submission date
13/02/2013
Registration date
27/02/2013
Last edited
03/11/2015
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Background and study aims
Contrast is a form of dye that improves the visibility of organs during diagnostic and treatment procedures. Contrast can also cause damage to the kidneys, called contrast-induced nephropathy (CIN), by interrupting the kidneys’ blood flow. Remote Ischemic PreConditioning (RIPC) is a new treatment which involves repeatedly inflating a blood pressure cuff on the upper arm, causing reduced blood flow in the arm, which sends a signal that may protect the kidneys from reduced blood flow. The aim of this study is to evaluate the effect of RIPC in patients at a high risk of CIN.

Who can participate?
Patients aged over 18 who are undergoing diagnostic/treatment contrast procedures, and who are at a high risk of CIN.

What does the study involve?
Participants are randomly allocated to either the experimental group or the control group. In the experimental group patients undergo RIPC - four cycles of inflating and deflating a blood pressure cuff on the forearm. The control group receives the same procedure but the blood pressure cuff does not inflate to the necessary pressure (sham/dummy preconditioning). All participants provide blood and urine samples and complete a short questionnaire.

What are the possible benefits and risks of participating?
We expect that RIPC will be a non-invasive, simple, low-cost and safe method to reduce CIN in high-risk patients. RIPC is considered safe and as far as we know there are no complications.

Where is the study run from?
Radboud University Medical Center (Netherlands).

When is the study starting and how long is it expected to run for?
October 2012 to October 2013.

Who is funding the study?
Radboud University Medical Center (Netherlands) and Cook Medical.

Who is the main contact?
Dr Michiel Warle

Contact information

Dr Michiel Warle
Scientific

Geert Grooteplein zuid 10
Department of Surgery, route 690
Nijmegen
6525 GA
Netherlands

Study information

Study designMulti-center blinded randomized controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleRemote Ischemic Preconditioning to reduce Contrast-Induced Nephropathy: a blinded randomized controlled trial
Study acronymRIPCIN
Study objectivesRemote ischemic preconditioning reduces contrast-induced nephropathy in high-risk patients.
Ethics approval(s)Ethical Committee 'CMO Arnhem/Nijmegen' (Netherlands), 16/10/2012 , ABR Number: 41890, CMO File number: NL41890.091.12
Health condition(s) or problem(s) studiedContrast-induced nephropathy
InterventionThe researcher performs the sham preconditioning or ischemic preconditioning procedure.

RIPC will be applied by 4 cycles of 5 minutes inflation and 5 minutes deflation of a standard blood pressure cuff around the upper arm at a pressure of the actual systolic blood pressure plus 50 mmHg.

Sham preconditioning will be applied in a similar fashion as the RIPC stimulus, but the blood pressure cuff is inflated to the actual diastolic blood pressure minus 10 mmHg.
Intervention typeProcedure/Surgery
Primary outcome measureCurrent primary outcome measures as of 14/04/2014:
Change in serum creatinine levels from baseline (day prior to contrast administration) to 48-72 hours after contrast administration

Previous primary outcome measures:
Change in serum creatinine levels from baseline (day prior to contrast administration) to 48 hours after contrast administration
Secondary outcome measuresCurrent secondary outcome measures as of 14/04/2014:
1. Change in biomarkers (for kidney injury) levels in blood and urine from baseline to 4-6 hours after contrast administration.
2. Incidence of CIN (>25% and/or 0.5 mg/dL rise in serum creatinine)
3. Death, rehospitalization and/or hemodialysis within 6 weeks after contrast-administration

Previous secondary outcome measures:
1. Change in biomarkers (for kidney injury) levels in blood and urine from baseline to 24 and/or 48 hours after contrast administration.
2. Incidence of CIN (>25% rise in serum creatinine)
3. Death, rehospitalization and/or hemodialysis within 6 weeks after contrast-administration
Overall study start date01/10/2012
Completion date01/10/2013

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants76
Key inclusion criteria1. Interventions with expected intravascular contrast volume > 100 mL:
1.1. Thoracic Endovascular Aortic Repair (TEVAR)
1.2. Endovascular Aortic Repair (EVAR)
1.3. Digital Substraction Angiography (DSA)
1.4. Percutaneous Transluminal Angioplasty (PTA)
1.5. Percutaneous Intentional Endovascular Revascularisation (PIER)
1.6. Carotic Artery Stenting (CAS)
1.7. Percutaneous coiling/embolisation procedures
1.8. Computed Tomographic Angiography
2. High-risk of CIN (according CBO guideline):
2.1. eGFR <45ml/min
2.2. eGFR <60ml/min and diabetes
2.3. eGFR <60ml/min ans 2 additional risk factors [peripheral artery disease, heart failure, >75 years, anaemia (Ht<0,39 for men and <0,36 for women), dehydration, use of diuretics and/or NSAID].
3. Informed consent
4. Both male and female, age > 18 years (no upper limit)
Key exclusion criteria1. Age < 18 years
2. Hemo- and peritoneal dialysis
3. Concomitant inclusion in another interventional study
4. Percutaneous coiling/embolisation procedures of the kidney
Date of first enrolment01/10/2012
Date of final enrolment01/10/2013

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Geert Grooteplein zuid 10
Nijmegen
6525 GA
Netherlands

Sponsor information

Radboud University Nijmegen Medical Centre (Netherlands)
Hospital/treatment centre

Geert Grooteplein zuid 10
Department of Surgery, route 690
Nijmegen
6525 GA
Netherlands

Website http://www.ru.nl/
ROR logo "ROR" https://ror.org/05wg1m734

Funders

Funder type

University/education

Radboud University Nijmegen Medical Centre (Netherlands)

No information available

Cook Medical

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article protocol 11/04/2014 Yes No
Results article results 01/10/2015 Yes No