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Shortening cardioplegic arrest time during combined coronary and valvular surgery

Shortening Cardioplegic Arrest Time during combined coronary and valvular surgery

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN65770930
Enrollment
160
Registered
2007-06-13
Start date
2007-10-01
Completion date
Unknown
Last updated
2017-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary artery and valve disease Circulatory System Coronary artery and valve disease

Interventions

Patients will be prepared for surgery and anaesthetised according to standard protocols. Moderate hypothermic cardiopulmonary bypass (CPB) (32°C) will be used in all patients. For the ?hybrid? group

Sponsors

United Bristol NHS Healthcare Trust (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
1. Clinical measures: 1.1. Duration of cardiopulmonary bypass 1.2. Duration of aortic cross clamp 1.3. Low cardiac output (LCO) 1.4. Blood loss 1.5. Transfusion requirement 1.6. Intubation time 1.7. Chest or wound infection 1.8. Any subsystem organ complication 1.9. Intensive Care Unit (ICU) and hospital stay 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 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

Countries

India, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 27, 2026