Trials / Completed
CompletedNCT01406678
Remote Ischemic Preconditioning in Coronary Artery Bypass Grafting With Cold Crystalloid Cardioplegic Arrest
Effect of Remote Ischemic Preconditioning in Patients Undergoing On-pump Coronary Artery Bypass Graft Surgery With Crystalloid Cardioplegic Arrest
- Status
- Completed
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 1,204 (actual)
- Sponsor
- University Hospital, Essen · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Remote ischemic preconditioning (RIPC) with transient upper limb ischemia/reperfusion reduces myocardial injury in patients undergoing on-pump coronary artery bypass (CABG) surgery with cross-clamp fibrillation or blood cardioplegia for myocardial protection. The present study assesses protection of heart, brain and kidney by RIPC under crystalloid cardioplegic arrest. The study also addresses safety and clinical outcome.
Detailed description
Remote ischemic preconditioning (RIPC) protocol after induction of anesthesia and before skin incision consists of 3 cycles of 5 minutes left upper arm ischemia by inflation of a blood pressure cuff to 200 mmHg and 5 minutes of reperfusion. For myocardial molecular analyses, left ventricular biopsies are taken before induction of cardioplegic cardiac arrest and at 10 minutes after aortic unclamping during reperfusion of the myocardium.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | RIPC | 3 cycles of 5 min left upper arm ischemia by inflation of a blood pressure cuff to 200 mmHg and 5 min reperfusion |
| PROCEDURE | Control | Coronary artery bypass surgery without remote ischemic preconditioning protocol |
| DRUG | isoflurane+sufentanil anesthesia | Anaesthesia is maintained by inhaled isoflurane in concentrations 0.7-0.8 % end-tidal with additional sufentanil injected during surgery, as required. During extracorporal circulation patients receive isoflurane via a vaporizer incorporated in the extracorporeal gas supply in the same concentrations. |
Timeline
- Start date
- 2008-07-01
- Primary completion
- 2018-03-01
- Completion
- 2020-04-01
- First posted
- 2011-08-01
- Last updated
- 2023-05-10
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT01406678. Inclusion in this directory is not an endorsement.