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

Primary Purpose

Contrast-induced Nephropathy

Status
Withdrawn
Phase
Not Applicable
Locations
Colombia
Study Type
Interventional
Intervention
Ischemic preconditioning
Endovenous normal saline
Sponsored by
Camilo Andrés Páez Angarita
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Contrast-induced Nephropathy focused on measuring contrast media, nephropathy, ischemic preconditioning

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Grupo Nefrología Fundación Valle del Lili

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Real ischemic preconditioning

Dummy ischemic preconditioning

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Adverse effects to preconditioning.
Any of pain in upper extremities, petechiae, bleeding from venopuncture sites, erythema.

Full Information

First Posted
April 24, 2017
Last Updated
October 9, 2018
Sponsor
Camilo Andrés Páez Angarita
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1. Study Identification

Unique Protocol Identification Number
NCT03136458
Brief Title
Efficacy of Remote Ischemic Preconditioning as Non Pharmacologic Strategy to Prevent Contrast Induced Nephropathy (PAIR)
Acronym
PAIR
Official Title
Efficacy of Remote Ischemic Preconditioning as Non Pharmacologic Strategy to Prevent Contrast Induced Nephropathy (PAIR Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Withdrawn
Why Stopped
No resources
Study Start Date
January 1, 2016 (Actual)
Primary Completion Date
October 9, 2018 (Actual)
Study Completion Date
October 9, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Camilo Andrés Páez Angarita

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Contrast-induced Nephropathy
Keywords
contrast media, nephropathy, ischemic preconditioning

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Real ischemic preconditioning
Arm Type
Experimental
Arm Description
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.
Arm Title
Dummy ischemic preconditioning
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Ischemic preconditioning
Other Intervention Name(s)
remote ischemic preconditioning
Intervention Description
Repeated remote ischemic preconditioning by arterial cuff insufflation.
Intervention Type
Drug
Intervention Name(s)
Endovenous normal saline
Other Intervention Name(s)
normal saline 0,9%
Intervention Description
endovenous normal saline 1 mL per Kg per hour before and after contrast media injection.
Primary Outcome Measure Information:
Title
Contrast induced nephropathy incidence
Description
Increase in serum creatinine by 0,3 mg/dL compared to initial values.
Time Frame
48 to 72 hours
Secondary Outcome Measure Information:
Title
Adverse effects to preconditioning.
Description
Any of pain in upper extremities, petechiae, bleeding from venopuncture sites, erythema.
Time Frame
0 to 72 hours.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Grupo Nefrología Fundación Valle del Lili
City
Cali
State/Province
Valle Del Cauca
Country
Colombia

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
18178787
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.
Results Reference
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PubMed Identifier
18987758
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.
Results Reference
background
PubMed Identifier
15911862
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. Erratum In: CMAJ. 2005 Nov 8;173(10):1210.
Results Reference
background
PubMed Identifier
22735307
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.
Results Reference
background
PubMed Identifier
24309187
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.
Results Reference
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Efficacy of Remote Ischemic Preconditioning as Non Pharmacologic Strategy to Prevent Contrast Induced Nephropathy (PAIR)

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