Efficacy of Remote Ischemic Preconditioning as Non Pharmacologic Strategy to Prevent Contrast Induced Nephropathy (PAIR Trial)
Overview
- Phase
- N/A
- Intervention
- Ischemic preconditioning
- Conditions
- Contrast-induced Nephropathy
- Sponsor
- Camilo Andrés Páez Angarita
- Locations
- 1
- Primary Endpoint
- Contrast induced nephropathy incidence
- Status
- Withdrawn
- Last Updated
- 7 years ago
Overview
Brief Summary
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
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.
Investigators
Camilo Andrés Páez Angarita
Internal Medicine Resident
Fundacion Clinica Valle del Lili
Eligibility Criteria
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 m
- •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.
Arms & Interventions
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.
Intervention: Ischemic preconditioning
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.
Intervention: Endovenous normal saline
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.
Intervention: Endovenous normal saline
Outcomes
Primary Outcomes
Contrast induced nephropathy incidence
Time Frame: 48 to 72 hours
Increase in serum creatinine by 0,3 mg/dL compared to initial values.
Secondary Outcomes
- Adverse effects to preconditioning.(0 to 72 hours.)