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

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

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03136458
Acronym
PAIR
Enrollment
0
Registered
2017-05-02
Start date
2016-01-01
Completion date
2018-10-09
Last updated
2018-10-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Contrast-induced Nephropathy

Keywords

contrast media, nephropathy, ischemic preconditioning

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.

Interventions

PROCEDUREIschemic preconditioning

Repeated remote ischemic preconditioning by arterial cuff insufflation.

DRUGEndovenous normal saline

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

Sponsors

Camilo Andrés Páez Angarita
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)

Intervention model description

Parallel assignment

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Contrast induced nephropathy incidence48 to 72 hoursIncrease in serum creatinine by 0,3 mg/dL compared to initial values.

Secondary

MeasureTime frameDescription
Adverse effects to preconditioning.0 to 72 hours.Any of pain in upper extremities, petechiae, bleeding from venopuncture sites, erythema.

Countries

Colombia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026