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ISRCTN
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ISRCTN76496973
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DOI
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10.1186/ISRCTN76496973
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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RIPCIN study: Remote Ischemic Preconditioning to reduce Contrast-Induced Nephropathy
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Scientific title
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Remote Ischemic Preconditioning to reduce Contrast-Induced Nephropathy: a blinded randomized controlled trial
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Acronym
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RIPCIN
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Serial number at source
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N/A
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Study hypothesis
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Remote ischemic preconditioning reduces contrast-induced nephropathy in high-risk patients.
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Lay summary
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Lay summary under review 2
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Ethics approval
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Ethical Committee 'CMO Arnhem/Nijmegen' (Netherlands), 16-10-2012 , ABR Number: 41890, CMO File number: NL41890.091.12
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Study design
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Multi-center blinded randomized controlled trial
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Countries of recruitment
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Netherlands
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Disease/condition/study domain
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Contrast-induced nephropathy
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Participants - inclusion criteria
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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)
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Participants - exclusion criteria
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1. Age < 18 years
2. Hemo- and peritoneal dialysis
3. Concomitant inclusion in another interventional study
4. Percutaneous coiling/embolisation procedures of the kidney
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Anticipated start date
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01/10/2012
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Anticipated end date
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01/10/2013
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Status of trial
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Ongoing |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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76
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Interventions
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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 10mmHg.
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Primary outcome measure(s)
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Change in serum creatinine levels from baseline (day prior to contrast administration) to 48 hours after contrast administration
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Secondary outcome measure(s)
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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
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Sources of funding
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Radboud University Nijmegen Medical Centre (Netherlands)
Cook Medical
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Trial website
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Publications
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Contact name
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Dr
Michiel
Warle
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Address
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Geert Grooteplein zuid 10
Department of Surgery, route 690
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City/town
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Nijmegen
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Zip/Postcode
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6525 GA
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Country
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Netherlands
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Sponsor
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Radboud University Nijmegen Medical Centre (Netherlands)
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Address
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Geert Grooteplein zuid 10
Department of Surgery, route 690
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City/town
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Nijmegen
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Zip/Postcode
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6525 GA
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Country
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Netherlands
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Sponsor website:
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http://www.ru.nl/
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Date applied
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13/02/2013
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Last edited
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27/02/2013
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Date ISRCTN assigned
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27/02/2013
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