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

NCT ID: NCT02729155

Last Updated: 2018-08-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

596 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2020-05-31

Brief Summary

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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

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randomized controlled trial

Conditions

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Ischemic Reperfusion Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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RIPre + RIPost

Intervention: RIPre 200 mmHg + RIPost 200 mmHg

Group Type EXPERIMENTAL

RIPre

Intervention Type PROCEDURE

Preconditioning 200 mmHg x 5 minutes before procedure

RIPost

Intervention Type PROCEDURE

Postconditioning 200 mmHg x 5 minutes after procedure

RIPre + Sham

Intervention: RIPre 200 mmHg + Sham 10 mmHg

Group Type EXPERIMENTAL

RIPre

Intervention Type PROCEDURE

Preconditioning 200 mmHg x 5 minutes before procedure

Sham-Post

Intervention Type PROCEDURE

Sham 10 mmHg x 5 minutes after procedure

Sham + RIPost

Intervention: Sham 10 mmHg + RIPost 200 mmHg

Group Type EXPERIMENTAL

RIPost

Intervention Type PROCEDURE

Postconditioning 200 mmHg x 5 minutes after procedure

Sham-Pre

Intervention Type PROCEDURE

Sham 10 mmHg x 5 minutes before procedure

Sham + Sham

Intervention: Sham 10 mmHg + Sham 10 mmHg

Group Type SHAM_COMPARATOR

Sham-Pre

Intervention Type PROCEDURE

Sham 10 mmHg x 5 minutes before procedure

Sham-Post

Intervention Type PROCEDURE

Sham 10 mmHg x 5 minutes after procedure

Interventions

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RIPre

Preconditioning 200 mmHg x 5 minutes before procedure

Intervention Type PROCEDURE

RIPost

Postconditioning 200 mmHg x 5 minutes after procedure

Intervention Type PROCEDURE

Sham-Pre

Sham 10 mmHg x 5 minutes before procedure

Intervention Type PROCEDURE

Sham-Post

Sham 10 mmHg x 5 minutes after procedure

Intervention Type PROCEDURE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Phramongkutklao College of Medicine and Hospital

OTHER

Sponsor Role lead

Responsible Party

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Col. Suthee Panichkul

Phramongkutklao College of Medicine and Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nakarin Sansanayudh, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Phramongkutklao College of Medicine and Hospital

Locations

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Department of Internal Medicine

Bangkok, , Thailand

Site Status RECRUITING

Countries

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Thailand

Central Contacts

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Nakarin Sansanayudh, MD,PhD

Role: CONTACT

+6627639300 ext. 93807

Pawit Pipatwattanakul, MD

Role: CONTACT

+6613728821

Facility Contacts

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Nakarin Sansanayudh, MD,PhD

Role: primary

+6623547600 ext. 93827

Pawit Pipatwattanakul, MD

Role: backup

+6613728821

Other Identifiers

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PMK-SCRIP-CIN

Identifier Type: -

Identifier Source: org_study_id

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