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The Influence of Remote Ischemic Preconditioning on Acute Kidney Injury After Cardiac Surgery

NCT ID: NCT00821522

Last Updated: 2021-11-17

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

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2010-05-31

Brief Summary

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Acute kidney injury is associated with cardiopulmonary bypass during heart surgery and its pathogenesis is similar to that of ischemia-reperfusion injury. Remote ischemic preconditioning attenuates myocardial ischemia-reperfusion injury in patients undergoing coronary bypass surgery. The investigators hypothesize that such preconditioning reduces the incidence of acute kidney injury associated with cardiopulmonary bypass.

Detailed Description

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Conditions

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Acute Kidney Insufficiency Acute Renal Insufficiency Acute Kidney Injury Ischemic Preconditioning

Keywords

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Acute Kidney Insufficiency Acute Renal Insufficiency Acute Kidney Injury Cardiac Surgical Procedures Ischemic Preconditioning

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Preconditioning

Group Type ACTIVE_COMPARATOR

Remote Ischemic Preconditioning

Intervention Type PROCEDURE

Three 5-minute intervals of leg ischemia induced by tourniquet inflation, prior to initiation of cardiopulmonary bypass.

Control

Standard clinical management during cardiac surgery.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Remote Ischemic Preconditioning

Three 5-minute intervals of leg ischemia induced by tourniquet inflation, prior to initiation of cardiopulmonary bypass.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patient undergoing heart surgery on cardiopulmonary bypass.

Exclusion Criteria

* Known peripheral vascular disease of the lower extremities associated with active skin necrosis or infection.
* End-stage renal disease.
* Inability to give informed consent.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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MaineHealth

OTHER

Sponsor Role collaborator

Robert Kramer, MD

OTHER

Sponsor Role lead

Responsible Party

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Robert Kramer, MD

Thoracic Surgery, MD

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Robert F Zimmerman, MD

Role: PRINCIPAL_INVESTIGATOR

MaineHealth

Locations

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Maine Medical Center

Portland, Maine, United States

Site Status

Countries

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United States

Other Identifiers

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3401

Identifier Type: -

Identifier Source: org_study_id