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

Phramongkutklao College of Medicine and Hospital596 enrolled

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

randomized controlled trial

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

596

Conditions

Ischemic Reperfusion Injury

Interventions

RIPrePROCEDURE

Preconditioning 200 mmHg x 5 minutes before procedure

RIPostPROCEDURE

Postconditioning 200 mmHg x 5 minutes after procedure

Sham-PrePROCEDURE

Sham 10 mmHg x 5 minutes before procedure

Sham-Post

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (1)

Department of Internal Medicine

Bangkok, Thailand

RECRUITING

Outcomes

Primary Outcomes

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 Outcomes

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

MACCE were composite of death, hospitalization, acute coronary syndrome, congestive heart failure and stroke or transient ischemic attack

Time frame: 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.

Time frame: 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

Time frame: 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

Central Contacts

Nakarin Sansanayudh, MD,PhD

CONTACT

+6627639300 dr_nakarin@hotmail.com

Pawit Pipatwattanakul, MD

CONTACT

+6613728821 pa_wit@hotmail.com

Data from ClinicalTrials.gov

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