Condition category
Urological and Genital Diseases
Date applied
13/02/2013
Date assigned
27/02/2013
Last edited
03/11/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Contact information

Type

Scientific

Primary contact

Dr Michiel Warle

ORCID ID

Contact details

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

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 measures

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

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

http://www.ru.nl/

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

Results - basic reporting

Publication summary

2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24721127
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26015372

Publication citations

  1. 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.

  2. 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.

Additional files

Editorial Notes