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

Camilo Andrés Páez Angarita

Status: Withdrawn

Conditions: Contrast-induced Nephropathy

Treatments: Procedure: Ischemic preconditioning; Drug: Endovenous normal saline

Study type: Interventional

Funder types: Other

Identifiers

NCT03136458

ValledelLili

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups

Real ischemic preconditioning

Experimental group

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.

Treatment:

Drug: Endovenous normal saline

Procedure: Ischemic preconditioning

Dummy ischemic preconditioning

Active Comparator group

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.

Treatment:

Drug: Endovenous normal saline