Efficacy of Remote Ischemic Preconditioning as Non Pharmacologic Strategy to Prevent Contrast Induced Nephropathy (PAIR)
- Conditions
- Contrast-induced Nephropathy
- Interventions
- Procedure: Ischemic preconditioningDrug: Endovenous normal saline
- Registration Number
- NCT03136458
- Lead Sponsor
- Camilo Andrés Páez Angarita
- 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Real ischemic preconditioning 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. Real ischemic preconditioning Endovenous normal saline 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. Dummy ischemic preconditioning Endovenous normal saline 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.
- Primary Outcome Measures
Name Time Method Contrast induced nephropathy incidence 48 to 72 hours Increase in serum creatinine by 0,3 mg/dL compared to initial values.
- Secondary Outcome Measures
Name Time Method Adverse effects to preconditioning. 0 to 72 hours. Any of pain in upper extremities, petechiae, bleeding from venopuncture sites, erythema.
Trial Locations
- Locations (1)
Grupo Nefrología Fundación Valle del Lili
🇨🇴Cali, Valle Del Cauca, Colombia