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

Study Overview
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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.

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.

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

Conditions
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Contrast-induced Nephropathy

Intervention / Treatment
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* Procedure: Ischemic preconditioning
* Drug: Endovenous normal saline


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Real ischemic preconditioning<br>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<br>* Repeated remote ischemic preconditioning by arterial cuff insufflation.<br>* Other names: remote ischemic preconditioning;Drug: Endovenous normal saline<br>* endovenous normal saline 1 mL per Kg per hour before and after contrast media injection.<br>* Other names: normal saline 0,9%;|
| Active Comparator: Dummy ischemic preconditioning<br>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<br>* endovenous normal saline 1 mL per Kg per hour before and after contrast media injection.<br>* Other names: normal saline 0,9%;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Contrast induced nephropathy incidence | 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. | Any of pain in upper extremities, petechiae, bleeding from venopuncture sites, erythema. | 0 to 72 hours. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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contrast media, nephropathy, ischemic preconditioning