Clinical trial
Effect of Remote Ischemic Preconditioning in Patients Undergoing On-pump Coronary Artery Bypass Graft Surgery With Crystalloid Cardioplegic Arrest
Name
WDHZ-TC-0801
Description
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.
Trial arms
Trial start
2008-07-01
Estimated PCD
2018-03-01
Trial end
2020-04-01
Status
Completed
Phase
Early phase I
Treatment
RIPC
3 cycles of 5 min left upper arm ischemia by inflation of a blood pressure cuff to 200 mmHg and 5 min reperfusion
Arms:
RIPC
Other names:
RIPC: Remote ischemic preconditioning, CABG: Coronary artery bypass grafting
Control
Coronary artery bypass surgery without remote ischemic preconditioning protocol
Arms:
Control
Other names:
Coronary artery bypass surgery
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.
Arms:
Control, RIPC
Other names:
Isoflurane, (2-chloro-2-(difluoromethoxy)-1,1,1-trifluoro-ethane), Forane, Sufentanil, Sufenta, (R-30730)
Size
1204
Primary endpoint
Perioperative extent of myocardial injury as measured by cardiac troponin I serum release over 72 hours after CABG surgery and its area under the curve (AUC).
72 hours postoperatively after CABG surgery
Eligibility criteria
Inclusion Criteria:
* Consecutive patients \>18 years of age
* Double- or triple-vessel coronary artery disease
* Elective isolated first-time CABG
* Combined valve surgery + CABG
* Written informed consent
Exclusion Criteria:
* Renal failure (creatinine ≥ 200 µmol/L)
* Peripheral vascular disease affecting upper limbs
* Preoperative inotropic support
* Any kind of mechanical assist device
* Acute or recent (\<4 weeks) acute coronary syndromes
* Any PCI (\<6 weeks)
* Any reasons for preoperative cTnI elevation
* Emergency surgery
* Redo surgery
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 1204, 'type': 'ACTUAL'}}
Updated at
2023-05-10
1 organization
1 product
1 indication
Organization
University Hospital EssenIndication
Myocardial Injury