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

October 9, 2018 updated by: Camilo Andrés Páez Angarita

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Colombia
    • Valle Del Cauca
      • Cali, Valle Del Cauca, Colombia
        • Grupo Nefrología Fundación Valle del Lili

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Procedure: Ischemic preconditioning
Repeated remote ischemic preconditioning by arterial cuff insufflation.
Other Names:
  • remote ischemic preconditioning
Drug: Endovenous normal saline
endovenous normal saline 1 mL per Kg per hour before and after contrast media injection.
Other Names:
  • normal saline 0,9%
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.
Drug: Endovenous normal saline
endovenous normal saline 1 mL per Kg per hour before and after contrast media injection.
Other Names:
  • normal saline 0,9%

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Camilo Andrés Páez Angarita

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Actual)

October 9, 2018

Study Completion (Actual)

October 9, 2018

Study Registration Dates

First Submitted

April 24, 2017

First Submitted That Met QC Criteria

April 27, 2017

First Posted (Actual)

May 2, 2017

Study Record Updates

Last Update Posted (Actual)

October 11, 2018

Last Update Submitted That Met QC Criteria

October 9, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ValledelLili

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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