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

Phramongkutklao College of Medicine and Hospital

Status: Unknown

Conditions: Ischemic Reperfusion Injury

Treatments: Procedure: RIPost; Procedure: Sham-Post; Procedure: RIPre; Procedure: Sham-Pre

Study type: Interventional

Funder types: Other

Identifiers

NCT02729155

PMK-SCRIP-CIN

Details and patient eligibility

About

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 description

randomized controlled trial

Enrollment: 596 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Triple Blind

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596 participants in 4 patient groups

RIPre + RIPost

Experimental group

Description:

Intervention: RIPre 200 mmHg + RIPost 200 mmHg

Treatment:

Procedure: RIPost

Procedure: RIPre

RIPre + Sham

Experimental group

Description:

Intervention: RIPre 200 mmHg + Sham 10 mmHg

Treatment:

Procedure: RIPre

Procedure: Sham-Post

Sham + RIPost

Experimental group

Description:

Intervention: Sham 10 mmHg + RIPost 200 mmHg

Treatment:

Procedure: Sham-Pre

Procedure: RIPost

Sham + Sham

Sham Comparator group

Description:

Intervention: Sham 10 mmHg + Sham 10 mmHg

Treatment:

Procedure: Sham-Pre

Procedure: Sham-Post