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Remote Ischemic Preconditioning to Prevent Contrast-Induced Kidney Injury in Diabetic Patients (PRINCES)

NCT07179874 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 71

Last updated 2025-09-22

No results posted yet for this study

Summary

This study investigates whether remote ischemic preconditioning (RIPC)-a non-invasive technique involving brief cycles of blood flow restriction to the arm-can prevent contrast-induced nephropathy (CIN) in diabetic patients undergoing coronary angiography. Diabetes mellitus increases the risk of CIN due to heightened oxidative stress and disrupted protective cellular signaling.

While previous research suggests that RIPC may activate renal protective mechanisms, its efficacy in diabetic individuals remains controversial, as metabolic and neurovascular alterations may compromise its effect. This randomized trial aims to determine whether RIPC reduces oxidative kidney damage and improves renal outcomes in this high-risk population. The study will also explore the biological basis for potential variability in response, focusing on oxidative stress biomarkers and early kidney injury indicators.

Conditions

  • Contrast-induced Acute Kidney Injury

Interventions

PROCEDURE

Remote Ischemic Preconditioning

This intervention involves a non-invasive, mechanical stimulus applied to an upper limb with the goal of activating systemic protective pathways against contrast-induced nephropathy in diabetic patients. Unlike pharmacologic or device-based interventions, RIPC: * Does not involve any drugs, biologics, or implants * Is performed using a standard blood pressure cuff, inflated to 50 mmHg above systolic pressure, specifically designed to induce repetitive transient limb ischemia * Consists of four alternating cycles of 5 minutes inflation followed by 5 minutes reperfusion * Is applied 45 minutes before coronary catheterization, timed to optimize systemic renal protection prior to exposure to contrast media * Targets activation of the heme oxygenase-1 (HO-1) enzymatic pathway, linking limb ischemia with antioxidant renal defense mechanisms Unlike interventions that rely solely on hydration or pharmacological antioxidants, this approach seeks to prime endogenous protective systems through is

Sponsors & Collaborators

  • Hospital General Universitario Santa Lucía

    collaborator OTHER

  • Universidad de Murcia

    lead OTHER

Principal Investigators

  • FRANCISCA RODRIGUEZ, Ph.D · University of Murcia-MURCIA

  • MARIA DOLORES RODRIGUEZ, M.D. Ph.D. · Hospital Santa Lucía-CARTAGENA, MURCIA

  • MARIA GALINDO MARTINEZ, M.D. Ph.D. · Hospital Santa Lucía-CARTAGENA, MURCIA

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-25
Primary Completion
2017-01-09
Completion
2017-01-09

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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 NCT07179874 on ClinicalTrials.gov