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OpenTrials
Completed

NCT Number: NCT00821522

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

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.

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Key information

Conditions

Acute Kidney Insufficiency Acute Kidney Injury Acute Renal Insufficiency Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Ischemic Preconditioning Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Maine Medical Center

Portland, Maine, 04102, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Remote ischemic preconditioning

Procedure

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Oliguria.

    Time frame: 12 hours after surgery.

  2. Incidence of acute kidney injury as defined by post-operative elevation in NGAL.

    Time frame: 3 hours after cardiopulmonary bypass.

Sponsors and collaborators

Lead sponsor

Robert Kramer, MD

Other

Collaborators

  • MaineHealth

Registry information

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Jan 13, 2009
Registry last updated
Nov 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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