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

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 9, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 9, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 24, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 27, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 2, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 11, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 9, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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