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

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

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

Study Overview

• Status: Unknown
• Conditions: Ischemic Reperfusion Injury
• Intervention / Treatment: Procedure: RIPre; Procedure: RIPost; Procedure: Sham-Post; Procedure: Sham-Pre

Detailed Description

randomized controlled trial

• Study Type: Interventional
• Enrollment (Anticipated): 596
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nakarin Sansanayudh, MD,PhD; Phone Number: 93807 +6627639300; Email: dr_nakarin@hotmail.com
• Study Contact Backup: Name: Pawit Pipatwattanakul, MD; Phone Number: +6613728821; Email: pa_wit@hotmail.com

Study Locations

• Thailand
  • Bangkok, Thailand, 10400
    • Recruiting
    • Department of Internal Medicine
    • Contact: Nakarin Sansanayudh, MD,PhD; Phone Number: 93827 +6623547600; Email: dr_nakarin@hotmail.com
    • Contact: Pawit Pipatwattanakul, MD; Phone Number: +6613728821; Email: pa_wit@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RIPre + RIPost; Intervention: RIPre 200 mmHg + RIPost 200 mmHg	Procedure: RIPre; Preconditioning 200 mmHg x 5 minutes before procedure; Procedure: RIPost; Postconditioning 200 mmHg x 5 minutes after procedure
Experimental: RIPre + Sham; Intervention: RIPre 200 mmHg + Sham 10 mmHg	Procedure: RIPre; Preconditioning 200 mmHg x 5 minutes before procedure; Procedure: Sham-Post; Sham 10 mmHg x 5 minutes after procedure
Experimental: Sham + RIPost; Intervention: Sham 10 mmHg + RIPost 200 mmHg	Procedure: RIPost; Postconditioning 200 mmHg x 5 minutes after procedure; Procedure: Sham-Pre; Sham 10 mmHg x 5 minutes before procedure
Sham Comparator: Sham + Sham; Intervention: Sham 10 mmHg + Sham 10 mmHg	Procedure: Sham-Post; Sham 10 mmHg x 5 minutes after procedure; Procedure: Sham-Pre; Sham 10 mmHg x 5 minutes before procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in sCr and eGFR from baseline		Within a period of 24 hours after contrast medium administration
Major adverse cerebrovascular and cardiovascular events (MACCE) in each intervention group	MACCE were composite of death, hospitalization, acute coronary syndrome, congestive heart failure and stroke or transient ischemic attack	Within a period of 6 months after contrast medium administration
Incidence(%) of CI-AKI in differrent subgroups of patient characteristics	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.	Within a period of 24 hours after contrast medium administration
Incidence(%) of CI-AKI in patients with vs without RIPre and RIPost	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
Incidence(%) of MACCE in differrent subgroups of patient characteristics	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	Within a period of 6 months after contrast medium administration
Incidence(%) of MACCE in patients with vs without RIPre and RIPost	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	Within a period of 6 months after contrast medium administration
Incidence(%) of MACCE in patients who have CI-AKI vs patients who have no CI-AKI	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	Within a period of 6 months after contrast medium administration

Collaborators and Investigators

• Sponsor: Phramongkutklao College of Medicine and Hospital
• Investigators: Principal Investigator: Nakarin Sansanayudh, MD,PhD, Phramongkutklao College of Medicine and Hospital

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Anticipated): May 1, 2020
• Study Completion (Anticipated): May 1, 2020

Study Registration Dates

• First Submitted: March 31, 2016
• First Submitted That Met QC Criteria: March 31, 2016
• First Posted (Estimate): April 6, 2016

Study Record Updates

• Last Update Posted (Actual): August 31, 2018
• Last Update Submitted That Met QC Criteria: August 28, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Angioplasty; Angiography; Ischemic Preconditioning; Postconditioning; Contrast-Induced Nephropathy
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Postoperative Complications; Ischemia; Reperfusion Injury
• Other Study ID Numbers: PMK-SCRIP-CIN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES