Single-cycle Remote Ischemic Preconditioning and Postconditioning for Prevention of Contrast-Induced Nephropathy

Overview

This trial is a 2 x 2 factorial design, double-blinded, randomized controlled trial to evaluate efficacy and safety of remote ischemic preconditioning and postconditioning for prevention of contrast-induced acute kidney injury in patient undergoing coronary angiography and angioplasty

Full Title of Study: “Efficacy of Single-cycle Remote Ischemic Pre/Post-conditioning, for Prevention of Contrast-induced Acute Kidney Injury in Patients With Chronic Kidney Disease Undergoing Coronary Angiography or Coronary Angioplasty”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Factorial Assignment
    • Primary Purpose: Prevention
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: May 2020

Detailed Description

randomized controlled trial

Interventions

  • Procedure: RIPre
    • Preconditioning 200 mmHg x 5 minutes before procedure
  • Procedure: RIPost
    • Postconditioning 200 mmHg x 5 minutes after procedure
  • Procedure: Sham-Pre
    • Sham 10 mmHg x 5 minutes before procedure
  • Procedure: Sham-Post
    • Sham 10 mmHg x 5 minutes after procedure

Arms, Groups and Cohorts

  • Experimental: RIPre + RIPost
    • Intervention: RIPre 200 mmHg + RIPost 200 mmHg
  • Experimental: RIPre + Sham
    • Intervention: RIPre 200 mmHg + Sham 10 mmHg
  • Experimental: Sham + RIPost
    • Intervention: Sham 10 mmHg + RIPost 200 mmHg
  • Sham Comparator: Sham + Sham
    • Intervention: Sham 10 mmHg + Sham 10 mmHg

Clinical Trial Outcome Measures

Primary Measures

  • Incidence of CI-AKI, which was defined as an increment of serum creatinine 0.5 mg/dL or a relative increase of 25% over the baseline value
    • Time Frame: Within a period of 24 hours after contrast medium administration

Secondary Measures

  • Change in sCr and eGFR from baseline
    • Time Frame: Within a period of 24 hours after contrast medium administration
  • Major adverse cerebrovascular and cardiovascular events (MACCE) in each intervention group
    • Time Frame: Within a period of 6 months after contrast medium administration
    • MACCE were composite of death, hospitalization, acute coronary syndrome, congestive heart failure and stroke or transient ischemic attack
  • Incidence(%) of CI-AKI in differrent subgroups of patient characteristics
    • Time Frame: Within a period of 24 hours after contrast medium administration
    • Patient characteristics include eGFR, global CIAKI risk score, contrast media volume and DM. Incidence of CI-AKI, which was defined as an increment of serum creatinine 0.5 mg/dL or a relative increase of 25% over the baseline value.
  • Incidence(%) of CI-AKI in patients with vs without RIPre and RIPost
    • Time Frame: Within a period of 24 hours after contrast medium administration
    • Incidence of CI-AKI, which was defined as an increment of serum creatinine 0.5 mg/dL or a relative increase of 25% over the baseline value
  • Incidence(%) of MACCE in differrent subgroups of patient characteristics
    • Time Frame: Within a period of 6 months after contrast medium administration
    • Patient characteristics include eGFR, global CIAKI risk score, contrast media volume and DM. MACCE were composite of death, hospitalization, acute coronary syndrome, congestive heart failure and stroke or transient ischemic attack
  • Incidence(%) of MACCE in patients with vs without RIPre and RIPost
    • Time Frame: Within a period of 6 months after contrast medium administration
    • Patient characteristics include eGFR, global CIAKI risk score, contrast media volume and DM. MACCE were composite of death, hospitalization, acute coronary syndrome, congestive heart failure and stroke or transient ischemic attack
  • Incidence(%) of MACCE in patients who have CI-AKI vs patients who have no CI-AKI
    • Time Frame: Within a period of 6 months after contrast medium administration
    • Incidence of CI-AKI, which was defined as an increment of serum creatinine 0.5 mg/dL or a relative increase of 25% over the baseline value within a period of 24 hours after contrast medium administration

Participating in This Clinical Trial

Inclusion Criteria

  • The patient have indication for coronary angiography or angioplasty.
  • Impaired renal function with reduced eGFR < 60 ml/min/1.73 m2 by CKD-EPI equation.
  • Written informed consent.

Exclusion Criteria

  • History of contrast allergy.
  • The patient had end-stage renal failure with the need for hemodialysis.
  • The patient take medications that affect the kidneys function within 48 hours before study.
  • The patient had acute kidney injury from any cause.
  • The patient was received contrast media within 2 weeks before study.
  • The patient had cardiac arrest or shock.
  • The patient had peripheral arterial disease (PAD)
  • Pregnancy
  • Refused to study

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Phramongkutklao College of Medicine and Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Col. Suthee Panichkul, Phramongkutklao College of Medicine and Hospital – Phramongkutklao College of Medicine and Hospital
  • Overall Official(s)
    • Nakarin Sansanayudh, MD,PhD, Principal Investigator, Phramongkutklao College of Medicine and Hospital
  • Overall Contact(s)
    • Nakarin Sansanayudh, MD,PhD, +6627639300, dr_nakarin@hotmail.com

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