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Completed

NCT Number: NCT00877305

Effect of Remote Ischemic Preconditioning on Cognitive Function After Cardiac Surgery

The purpose of this study is to evaluate the effects of Remote Ischemic Preconditioning on cognitive function in patients undergoing cardiac surgery compared to control intervention.

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Key information

Conditions

Cardiac Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University Hospital Schleswig-Holstein

Kiel, Germany

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

  • Emergency cases
  • Myocardial infarction up to 7 days prior to enrollment
  • Stroke up to 2 months prior to enrollment
  • Ejection fraction less than 30%
  • Previous psychiatric and neurological illness
  • Inability to give informed consent

Treatment and study plan

Remote ischemic preconditioning

Procedure

RIPC will be induced during anesthesia by four 5-min cycles of upper limb ischemia and 5-min reperfusion using a blood-pressure cuff inflated to 200 mmHg (at least a pressure 15 mm Hg greater than the systolic arterial pressure measured via the arterial line).

Control

Other

Sham intervention with four 5-min cycles of inflation of the blood pressure cuff at 20 mmHg and 5 min deflation without any upper leg ischaemia.

Primary outcomes

  1. The primary outcome measure is postoperative neurocognitive dysfunction.

    Time frame: Preoperative, 1 week and 3 months after surgery

Secondary outcomes

  1. New onset of atrial fibrillation, myocardial and kidney injury, cardiac function (previous NCT00882622 study).

    Time frame: Within 24-48 hours after surgery

Sponsors and collaborators

Lead sponsor

Patrick Meybohm

Other

Collaborators

  • University Hospital Schleswig-Holstein

Registry information

Important dates

Study start
2008
Primary completion
2010
First posted
Apr 7, 2009
Registry last updated
Jan 18, 2012

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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