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Effect of Remote Ischemic Preconditioning on the Incidence of Contrast Induced Nephropathy in Patients Undergoing EVAR

NCT05350683 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2022-04-28

No results posted yet for this study

Summary

Introduction: Contrast induced nephropathy (CIN) is a major inconvenience in the use of iodinated contrast media (ICM) and it is associated with a significant increase in morbimortality and cost of hospitalization. Remote ischemic preconditioning (RIPC) is a non-invasive and cost-effective tissular protection technique that has proven beneficial in decreasing renal insult in patients receiving intravascular contrast. Aim: The primary outcome of this study is to evaluate the impact of RIPC on the incidence of CIN in patients undergoing endovascular aneurysm repair.Material and Methods: Patients suffering from aortic aneurysm were recruited prior to the administration of iodinated contrast media. Randomization was used to assign patients into the control/RIPC groups. Biochemical parameters determined renal function before and after surgery in immediate (24-72 hours) and at 30 days' follow-up.

Conditions

  • Aortic Aneurysm
  • Ischemic Preconditioning

Interventions

PROCEDURE

Remote ischemic preconditioning

In the 12 hours prior to surgery, the principal investigator performed the remote ischemic preconditioning (RIPC) following the protocol: 4 cycles of inflation/deflation of a pneumatic arterial tourniquet on the non-dominant upper extremity. Considering inflated a pressure of 50mmHg above systolic blood pressure for 5 minutes, followed by 5 minutes of deflation. Patients included in the preconditioning group were randomized at a rate of 1:1 consecutively.

Sponsors & Collaborators

  • Hospital Clínico Universitario de Valladolid

    collaborator OTHER

  • Vascular Investigation Network Spanish Society for Angiology and Vascular Surgery

    lead NETWORK

Principal Investigators

  • Diana Gutierrez · Member

  • Enrique San Norberto · Member

  • Elena Garcia · Member

  • Liliana Domingos · Member

  • Cintia Flota · Member

  • Carlos Vaquero · Member

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-01
Primary Completion
2019-09-17
Completion
2020-05-20

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05350683 on ClinicalTrials.gov