Cardiac Surgery
Conditions
Keywords
Ischemic Preconditioning, Cognitive function
Brief summary
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.
Interventions
PROCEDURERemote Ischemic Preconditioning
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).
OTHERControl
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.
Sponsors
University Hospital Schleswig-Holstein
Patrick Meybohm
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measure is postoperative neurocognitive dysfunction. | Preoperative, 1 week and 3 months after surgery |
Secondary
| Measure | Time frame |
|---|---|
| New onset of atrial fibrillation, myocardial and kidney injury, cardiac function (previous NCT00882622 study). | Within 24-48 hours after surgery |
Countries
Germany
Outcome results
None listed