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

NCT07179874 | Completed

• 1 other identifier: Tl14-13 MGM
• Study Type: interventional
• Target: 71
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Remote Ischemic Preconditioning; Diabetes Mellitus; Heme Oxygenase-1

Outcome Measures

Primary Outcomes (1)

• Incidence of Contrast-Induced Nephropathy (CIN), defined as an increase in serum creatinine ≥25% or ≥0.5 mg/dL from baseline within 72 hours after contrast exposure

  * Metric: Absolute change in serum creatinine level (mg/dL) * Time Frame: 24, 48, and 72 hours post-contrast administration * Purpose: Evaluates the incidence and severity of contrast-induced nephropathy (CIN) * Rationale: Creatinine is a key biomarker for acute kidney injury, particularly relevant in diabetic populations receiving iodinated contrast agents

  Time Frame: 24, 48, and 72 hours post-contrast administration

Secondary Outcomes (6)

• - Changes in Heme Oxygenase-1 (HO-1) concentration in plasma .

  24, 48, and 72 hours after contrast administration

• Duration of ICU/Hospital Stay.

  Up to 30 days post-ICU admission

• Survival .

  6 weeks post-hospital discharge

• Hospital Readmission Rate

  6 weeks post-hospital discharge

• Clinical Status

  6 weeks post-hospital discharge

Other Outcomes (4)

• Neutrophil and Lymphocyte Counts and Neutrophil-to-Lymphocyte Ratio (NLR)

  From baseline to 72 hours after coronary catheterization

• NT-proBNP Levels (Cardiac Stress Marker)

  From baseline to 72 hours after coronary catheterization

• Ferritin (Ft) Levels

  From baseline to 72 hours after coronary catheterization

Study Arms (2)

Remote ischemyc preconditioning.

EXPERIMENTAL

Participants assigned to this arm received: * Standard hydration therapy: intravenous infusion of 0.9% saline at 1 ml/kg/h for 12 hours before and after coronary catheterization * Plus the RIPC procedure: four alternating cycles of upper-arm ischemia (inflating a blood pressure cuff 50 mmHg above systolic pressure for 5 minutes, followed by 5 minutes of reperfusion) performed approximately 45 minutes before catheterization This group was intended to assess the protective renal effects of RIPC in diabetic patients undergoing exposure to intravenous contrast media.

Procedure: Remote Ischemic Preconditioning

Control Arm-NO RIPC

NO INTERVENTION

Participants in the control arm receive standard care without remote ischemic preconditioning (RIPC). All patients undergo intravenous hydration as part of standard preventive measures prior to coronary catheterization. * Intervention: 0.9% saline solution administered intravenously at a rate of 1 ml/kg/hour * Timing: Initiated 12 hours before the procedure and maintained for 12 hours afterward * Additional Notes: No cuff inflation or ischemic maneuvers are performed. Patients do not receive sham stimulation or any form of simulated ischemia. This arm reflects usual clinical practice in patients undergoing catheterization who meet inclusion criteria.

Interventions

Remote Ischemic Preconditioning PROCEDURE

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

Remote ischemyc preconditioning.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient diagnosed with diabetes mellitus.
• Age above 18 years.
• Admission to the ICU due to acute coronary syndrome.
• Indication for undergoing a coronary arteriography (either urgent or scheduled)
• Patients who received a coronary arteriography within the last 72 hours (if previously recruited, counted as new for randomization).
• Possibility to perform the RIPC maneuver without delaying the catheterization

You may not qualify if:

• Absence of diabetes mellitus.
• Pregnant women.
• Renal transplant recipients.
• Patients who underwent urological procedures or received intravenous contrast within the last 72 hours.
• Diagnosis of end-stage renal disease requiring hemodialysis.
• Participation in another clinical trial.

Sponsors & Collaborators

• Universidad de Murcia: lead
• Hospital General Universitario Santa Lucía: collaborator

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• FRANCISCA RODRIGUEZ, Ph.D

  University of Murcia-MURCIA

  PRINCIPAL INVESTIGATOR

• MARIA DOLORES RODRIGUEZ, M.D. Ph.D.

  Hospital Santa Lucía-CARTAGENA, MURCIA

  PRINCIPAL INVESTIGATOR

• MARIA GALINDO MARTINEZ, M.D. Ph.D.

  Hospital Santa Lucía-CARTAGENA, MURCIA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Participants were randomized using block randomization with sealed opaque envelopes.

Study Record Dates

• First Submitted: August 15, 2025
• First Posted: September 18, 2025
• Study Start: February 25, 2015
• Primary Completion: January 9, 2017
• Study Completion: January 9, 2017
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: Beginning 6 months after publication of the primary results; data available for up to 2 years.
• Access Criteria: Researchers must submit a detailed, methodologically sound proposal and sign a data use agreement that protects participant confidentiality