Shortening cardioplegic arrest time during combined coronary and valvular surgery

Completed

Conditions: Circulatory System
Coronary artery and valve disease

Registration Number: ISRCTN65770930

Lead Sponsor: nited Bristol NHS Healthcare Trust (UK)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 160

Inclusion Criteria

1. Adults with multiple vessel coronary disease and any aortic valve disease and/or any mitral valve disease
2. Surgeons willing to carry out operation via either method

Exclusion Criteria

1. Single vessel coronary disease
2. Marked calcific degeneration of the mitral annulus
3. Reoperation
4. Malignancy
5. Debilitating neurological disease
6. Ongoing sepsis or endocarditis
7. Carotid artery stenosis greater than 75%
8. Critical limb ischaemia
9. Emergency operation for unstable angina
10. Salvage procedures

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Composite endpoint of death, postoperative myocardial infarction, arrhythmia, requirement for pacing for more than 12 hours and/or inotropic support for more than 12 hours.

Secondary Outcome Measures

Name	Time	Method
1. Clinical measures: <br>1.1. Duration of cardiopulmonary bypass <br>1.2. Duration of aortic cross clamp <br>1.3. Low cardiac output (LCO) <br>1.4. Blood loss <br>1.5. Transfusion requirement <br>1.6. Intubation time <br>1.7. Chest or wound infection <br>1.8. Any subsystem organ complication <br>1.9. Intensive Care Unit (ICU) and hospital stay<br>2. Metabolic stress: metabolites extracted from myocardial biopsies from the apex of the left ventricle will include adenine nucleotides and related compounds as well as amino acids (alanine/glutamate ratio) and lactate<br>3. Reperfusion injury: serum concentrations of troponin I will be determined prior to surgery, and at 1, 4, 12, 24, 48 and 72 hours post-operatively