Clinical trial NCT03136458: Efficacy of Remote Ischemic Preconditioning as Non Pharmacologic Strategy to Prevent Contrast Induced Nephropathy (PAIR)
Official title: Efficacy of Remote Ischemic Preconditioning as Non Pharmacologic Strategy to Prevent Contrast Induced Nephropathy (PAIR Trial)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Contrast-induced Nephropathy
Keywords: contrast media
nephropathy
ischemic preconditioning
Lead sponsor: Fundacion Clinica Valle del Lili
Sponsor class: OTHER
First posted: 2017-05-02
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel assignment
Primary purpose: PREVENTION

Brief summary: This study evaluates remote ischemic preconditioning as an strategy to avoid contrast induced nephropathy. All of the patients will receive endovenous normal saline to prevent nephropathy, half of the patients will receive remote ischemic preconditioning while the other half will not.

Detailed description: This study evaluates remote ischemic preconditioning as an strategy to avoid contrast induced nephropathy, this preconditioning is administered through repeated insufflation of an arterial pressure cuff in one of the patient arms, which in theory liberates vasoactive mediators that prevents the ischemic damage to the kidneys secondary to contrast media. All of the patients will receive endovenous normal saline to prevent nephropathy, which is a common strategy in our institution. Half of the patients will receive remote ischemic preconditioning while the other half will only receive a dummy preconditioning intended to keep the double blind strategy of the trial.

The main endpoint will be to ascertain the incidence of contrast induced nephropathy in both arms of the study, as a way to evaluate the efficacy of this strategy.

Eligibility criteria: Inclusion Criteria:

* Hospitalized in general wards, emergency room or ambulatory consult.
* 18 years or older.
* Requires computerized tomography with endovenous contrast.
* Glomerular filtration rate between 30 - 60 mL/minute/1,73 m2.
* Patient accepts and signs informed consent.

Exclusion Criteria:

* Allergic to contrast media.
* Unable to accept or sign informed consent.
* Did not received endovenous saline before and/or after the contrast procedure.
* Peripheral arterial disease.
* Bilateral upper extremities lymph node dissection or any situation impending arterial pressure taking.
* Morbid obesity (body mass index 40 or more).
* Arterial systolic pressure greater than 175 mmHg.

Primary outcomes:
measure: Contrast induced nephropathy incidence
timeFrame: 48 to 72 hours
Secondary outcomes:
measure: Adverse effects to preconditioning.
timeFrame: 0 to 72 hours.
Other outcomes:
Locations:
city: Cali
country: Colombia
facility: Grupo Nefrología Fundación Valle del Lili
state: Valle Del Cauca
Study officials:
References:
citation: Rudnick M, Feldman H. Contrast-induced nephropathy: what are the true clinical consequences? Clin J Am Soc Nephrol. 2008 Jan;3(1):263-72. doi: 10.2215/CJN.03690907.
citation: Holscher B, Heitmeyer C, Fobker M, Breithardt G, Schaefer RM, Reinecke H. Predictors for contrast media-induced nephropathy and long-term survival: prospectively assessed data from the randomized controlled Dialysis-Versus-Diuresis (DVD) trial. Can J Cardiol. 2008 Nov;24(11):845-50. doi: 10.1016/s0828-282x(08)70193-4.
citation: Goldenberg I, Matetzky S. Nephropathy induced by contrast media: pathogenesis, risk factors and preventive strategies. CMAJ. 2005 May 24;172(11):1461-71. doi: 10.1503/cmaj.1040847.
citation: Bonventre JV. Limb ischemia protects against contrast-induced nephropathy. Circulation. 2012 Jul 24;126(4):384-7. doi: 10.1161/CIRCULATIONAHA.112.119701. Epub 2012 Jun 26. No abstract available.
citation: Gassanov N, Nia AM, Caglayan E, Er F. Remote ischemic preconditioning and renoprotection: from myth to a novel therapeutic option? J Am Soc Nephrol. 2014 Feb;25(2):216-24. doi: 10.1681/ASN.2013070708. Epub 2013 Dec 5.