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

NCT03136458 | Withdrawn DMC

• 1 other identifier: ValledelLili
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Contrast-induced Nephropathy

Keywords

contrast media; nephropathy; ischemic preconditioning

Outcome Measures

Primary Outcomes (1)

• Contrast induced nephropathy incidence

  Increase in serum creatinine by 0,3 mg/dL compared to initial values.

  48 to 72 hours

Secondary Outcomes (1)

• Adverse effects to preconditioning.

  0 to 72 hours.

Study Arms (2)

Real ischemic preconditioning

EXPERIMENTAL

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.

Procedure: Ischemic preconditioning; Drug: Endovenous normal saline

Dummy ischemic preconditioning

ACTIVE COMPARATOR

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.

Drug: Endovenous normal saline

Interventions

Ischemic preconditioning PROCEDURE

Repeated remote ischemic preconditioning by arterial cuff insufflation.

Also known as: remote ischemic preconditioning

Real ischemic preconditioning

Endovenous normal saline DRUG

endovenous normal saline 1 mL per Kg per hour before and after contrast media injection.

Also known as: normal saline 0,9%

Dummy ischemic preconditioning; Real ischemic preconditioning

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hospitalized in general wards, emergency room or ambulatory consult.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Camilo Andrés Páez Angarita: lead

Study Sites (1)

Grupo Nefrología Fundación Valle del Lili

Cali, Valle del Cauca Department, Colombia

Location

Related Publications (5)

• 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.

  PMID: 18178787 BACKGROUND

• 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.

  PMID: 18987758 BACKGROUND

• 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.

  PMID: 15911862 BACKGROUND

• 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.

  PMID: 22735307 BACKGROUND

• 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.

  PMID: 24309187 BACKGROUND

MeSH Terms

Conditions

Kidney Diseases

Interventions

Ischemic Preconditioning

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Internal Medicine Resident

Model Details: Parallel assignment

Study Record Dates

• First Submitted: April 24, 2017
• First Posted: May 2, 2017
• Study Start: January 1, 2016
• Primary Completion: October 9, 2018
• Study Completion: October 9, 2018
• Last Updated: October 11, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)