Plain English Summary
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
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Remote Ischemic Preconditioning to reduce Contrast-Induced Nephropathy: a blinded randomized controlled trial
Acronym
RIPCIN
Study hypothesis
Remote ischemic preconditioning reduces contrast-induced nephropathy in high-risk patients.
Ethics approval
Ethical Committee 'CMO Arnhem/Nijmegen' (Netherlands), 16/10/2012 , ABR Number: 41890, CMO File number: NL41890.091.12
Study design
Multi-center blinded randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Contrast-induced nephropathy
Intervention
The 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 type
Procedure/Surgery
Phase
Drug names
Primary outcome measure
Current 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 measures
Current 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 trial start date
01/10/2012
Overall trial end date
01/10/2013
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. 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)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
76
Participant exclusion criteria
1. Age < 18 years
2. Hemo- and peritoneal dialysis
3. Concomitant inclusion in another interventional study
4. Percutaneous coiling/embolisation procedures of the kidney
Recruitment start date
01/10/2012
Recruitment end date
01/10/2013
Locations
Countries of recruitment
Netherlands
Trial participating centre
Geert Grooteplein zuid 10
Nijmegen
6525 GA
Netherlands
Sponsor information
Organisation
Radboud University Nijmegen Medical Centre (Netherlands)
Sponsor details
Geert Grooteplein zuid 10
Department of Surgery
route 690
Nijmegen
6525 GA
Netherlands
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
University/education
Funder name
Radboud University Nijmegen Medical Centre (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Cook Medical
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24721127
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26015372
Publication citations
-
Protocol
Sterenborg TB, Menting TP, de Waal Y, Donders R, Wever KE, Lemson MS, van der Vliet DJ, Wetzels JF, SchultzeKool LJ, Warlé MC, Remote ischemic preconditioning to reduce contrast-induced nephropathy: study protocol for a randomized controlled trial., Trials, 2014, 15, 119, doi: 10.1186/1745-6215-15-119.
-
Results
Menting TP, Sterenborg TB, de Waal Y, Donders R, Wever KE, Lemson MS, van der Vliet JA, Wetzels JF, SchultzeKool LJ, Warlé MC, Remote Ischemic Preconditioning To Reduce Contrast-Induced Nephropathy: A Randomized Controlled Trial, Eur J Vasc Endovasc Surg, 2015 , doi: 10.1016/j.ejvs.2015.04.002.