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

November 9, 2021 updated by: Robert Kramer, MD
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maine
      • Portland, Maine, United States, 04102
        • Maine Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Preconditioning
Procedure: Remote Ischemic Preconditioning
Three 5-minute intervals of leg ischemia induced by tourniquet inflation, prior to initiation of cardiopulmonary bypass.
No Intervention: Control
Standard clinical management during cardiac surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of acute kidney injury, after surgery, as defined by elevation in serum creatinine greater than or equal to 0.3 mg/dl.
Time Frame: 48 hours after surgery.
48 hours after surgery.

Secondary Outcome Measures

Outcome Measure
Time Frame
Oliguria.
Time Frame: 12 hours after surgery.
12 hours after surgery.
Incidence of acute kidney injury as defined by post-operative elevation in NGAL.
Time Frame: 3 hours after cardiopulmonary bypass.
3 hours after cardiopulmonary bypass.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Robert Kramer, MD

Collaborators

MaineHealth

Investigators

  • Principal Investigator: Robert F Zimmerman, MD, MaineHealth

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

May 1, 2010

Study Registration Dates

First Submitted

January 9, 2009

First Submitted That Met QC Criteria

January 9, 2009

First Posted (Estimate)

January 13, 2009

Study Record Updates

Last Update Posted (Actual)

November 17, 2021

Last Update Submitted That Met QC Criteria

November 9, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3401

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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