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| Name | Class |
|---|---|
| University Hospital Schleswig-Holstein | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RIPC | Active Comparator | Remote Ischemic Preconditioning |
|
| CONTROL | Placebo Comparator | Control |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| The primary outcome measure is postoperative neurocognitive dysfunction. | Preoperative, 1 week and 3 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| New onset of atrial fibrillation, myocardial and kidney injury, cardiac function (previous NCT00882622 study). | Within 24-48 hours after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patrick Meybohm, MD | University Hospital Schleswig-Holstein | Principal Investigator |
| Berthold Bein, MD | University Hospital Schleswig-Holstein | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Schleswig-Holstein | Kiel | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24712447 | Derived | Zitta K, Meybohm P, Bein B, Gruenewald M, Lauer F, Steinfath M, Cremer J, Zacharowski K, Albrecht M. Activities of cardiac tissue matrix metalloproteinases 2 and 9 are reduced by remote ischemic preconditioning in cardiosurgical patients with cardiopulmonary bypass. J Transl Med. 2014 Apr 8;12:94. doi: 10.1186/1479-5876-12-94. | |
| 23741380 |
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| 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. |
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| Meybohm P, Renner J, Broch O, Caliebe D, Albrecht M, Cremer J, Haake N, Scholz J, Zacharowski K, Bein B. Postoperative neurocognitive dysfunction in patients undergoing cardiac surgery after remote ischemic preconditioning: a double-blind randomized controlled pilot study. PLoS One. 2013 May 31;8(5):e64743. doi: 10.1371/journal.pone.0064743. Print 2013. |