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

Not Applicable

• Conditions: Ischemic Reperfusion Injury
• Interventions: Procedure: RIPre; Procedure: RIPost; Procedure: Sham-Post; Procedure: Sham-Pre

• Registration Number: NCT02729155
• Lead Sponsor: Phramongkutklao College of Medicine and Hospital

Brief Summary

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

Detailed Description

randomized controlled trial

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2016-03-31
• Study First Submitted QC: 2016-03-31
• Study First Posted: 2016-04-06
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-28
• Last Update Posted: 2018-08-31
• Primary Completion: 2020-05
• Study Completion: 2020-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 596

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
RIPre + RIPost	RIPost	Intervention: RIPre 200 mmHg + RIPost 200 mmHg
RIPre + Sham	RIPre	Intervention: RIPre 200 mmHg + Sham 10 mmHg
RIPre + Sham	Sham-Post	Intervention: RIPre 200 mmHg + Sham 10 mmHg
Sham + RIPost	RIPost	Intervention: Sham 10 mmHg + RIPost 200 mmHg
Sham + RIPost	Sham-Pre	Intervention: Sham 10 mmHg + RIPost 200 mmHg
Sham + Sham	Sham-Post	Intervention: Sham 10 mmHg + Sham 10 mmHg
RIPre + RIPost	RIPre	Intervention: RIPre 200 mmHg + RIPost 200 mmHg
Sham + Sham	Sham-Pre	Intervention: Sham 10 mmHg + Sham 10 mmHg

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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	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	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	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 patients with vs without RIPre and RIPost	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 differrent subgroups of patient characteristics	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	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

Trial Locations

Locations (1)

Department of Internal Medicine; 🇹🇭 Bangkok, Thailand