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

Contrast-induced Nephropathy Clinical Trial

— PAIR  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03136458
• Other study ID #: ValledelLili
• Status: Withdrawn
• Phase: N/A
• Start date: January 1, 2016
• Est. completion date: October 9, 2018

Study information

• Verified date: October 2018
• Source: Fundacion Clinica Valle del Lili
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 9, 2018
• Est. primary completion date: October 9, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Contrast-induced Nephropathy
• Kidney Diseases

Intervention

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.

Locations

Country	Name	City	State
Colombia	Grupo Nefrología Fundación Valle del Lili	Cali	Valle Del Cauca

Sponsors (1)

Lead Sponsor	Collaborator
Camilo Andrés Páez Angarita

Country where clinical trial is conducted

Colombia, 

References & Publications (5)

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. — View 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. Review. — View Citation

Goldenberg I, Matetzky S. Nephropathy induced by contrast media: pathogenesis, risk factors and preventive strategies. CMAJ. 2005 May 24;172(11):1461-71. Review. Erratum in: CMAJ. 2005 Nov 8;173(10):1210. — View Citation

Hölscher 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Contrast induced nephropathy incidence	Increase in serum creatinine by 0,3 mg/dL compared to initial values.	48 to 72 hours
Secondary	Adverse effects to preconditioning.	Any of pain in upper extremities, petechiae, bleeding from venopuncture sites, erythema.	0 to 72 hours.