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
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
Scientific
Geert Grooteplein zuid 10
Department of Surgery, route 690
Nijmegen
6525 GA
Netherlands
Study information
| Study design | Multi-center blinded randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Remote Ischemic Preconditioning to reduce Contrast-Induced Nephropathy: a blinded randomized controlled trial |
| Study acronym | RIPCIN |
| Study objectives | Remote 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) studied | 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 |
| 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 study start date | 01/10/2012 |
| Completion date | 01/10/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 76 |
| Key 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) |
| Key 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 |
| Date of first enrolment | 01/10/2012 |
| Date of final enrolment | 01/10/2013 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
6525 GA
Netherlands
Sponsor information
Hospital/treatment centre
Geert Grooteplein zuid 10
Department of Surgery, route 690
Nijmegen
6525 GA
Netherlands
| Website | http://www.ru.nl/ |
|---|---|
"ROR" |
https://ror.org/05wg1m734 |
Funders
Funder type
University/education
No information available
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not 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 |
