Efficacy of Remote Ischemic Preconditioning as Non Pharmacologic Strategy to Prevent Contrast Induced Nephropathy (PAIR)

Overview

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.

Full Title of Study: “Efficacy of Remote Ischemic Preconditioning as Non Pharmacologic Strategy to Prevent Contrast Induced Nephropathy (PAIR Trial)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: October 9, 2018

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.

Interventions

  • Procedure: Ischemic preconditioning
    • Repeated remote ischemic preconditioning by arterial cuff insufflation.
  • Drug: Endovenous normal saline
    • endovenous normal saline 1 mL per Kg per hour before and after contrast media injection.

Arms, Groups and Cohorts

  • Experimental: Real ischemic preconditioning
    • Insufflation of an arterial pressure cuff located in one upper extremity, during 4 cycles, each with a duration of 5 minutes insufflation and 5 minutes of disinflation. The cuff will be insufflated to reach 50 mmHg above the systolic arterial pressure of the patient.
  • Active Comparator: Dummy ischemic preconditioning
    • Insufflation of an arterial pressure cuff located in one upper extremity, during 4 cycles, each with a duration of 5 minutes insufflation and 5 minutes of disinflation. The cuff will be insufflated to reach 10 mmHg above the diastolic arterial pressure of the patient.

Clinical Trial Outcome Measures

Primary Measures

  • Contrast induced nephropathy incidence
    • Time Frame: 48 to 72 hours
    • Increase in serum creatinine by 0,3 mg/dL compared to initial values.

Secondary Measures

  • Adverse effects to preconditioning.
    • Time Frame: 0 to 72 hours.
    • Any of pain in upper extremities, petechiae, bleeding from venopuncture sites, erythema.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Camilo Andrés Páez Angarita
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Camilo Andrés Páez Angarita, Internal Medicine Resident – Fundacion Clinica Valle del Lili

References

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.

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.

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. Erratum In: CMAJ. 2005 Nov 8;173(10):1210.

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.

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.

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