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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-01

Study Completion Date

2018-10-09

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Contrast-induced Nephropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel assignment

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

Ischemic preconditioning

Intervention Type PROCEDURE

Repeated remote ischemic preconditioning by arterial cuff insufflation.

Endovenous normal saline

Intervention Type DRUG

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

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.

Group Type ACTIVE_COMPARATOR

Endovenous normal saline

Intervention Type DRUG

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

Interventions

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Ischemic preconditioning

Repeated remote ischemic preconditioning by arterial cuff insufflation.

Intervention Type PROCEDURE

Endovenous normal saline

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

Intervention Type DRUG

Other Intervention Names

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remote ischemic preconditioning normal saline 0,9%

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No