ISRCTN - ISRCTN65770930: Shortening cardioplegic arrest time during combined coronary and valvular surgery

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Raimondo Ascione

ORCID ID

Contact details

Bristol Heart Institute
University of Bristol
Level 7
Bristol Royal Infirmary
Marlborough Street
Bristol
BS2 8HW
United Kingdom
+44 (0)117 928 3145
r.ascione@bristol.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

CS/2006/2267 (Sponsor's reference number)

Study information

Scientific title

Shortening Cardioplegic Arrest Time during combined coronary and valvular surgery

Acronym

SCAT

Study hypothesis

Our primary hypothesis is that by modifying the way in which combined coronary artery bypass grafting (CABG) and valve replacement surgery is carried out cardioplegic arrest time can be shortened, reperfusion injury will be reduced and functional and clinical outcome improved compared to using the conventional method of surgery.

Conventionally the heart is arrested throughout both the valvular and coronary phases of the procedure using cold blood cardioplegia. With the modified hybrid approach the coronary surgery is carried out first on the beating heart with cardiopulmonary bypass, but without cardioplegic arrest. The heart is then arrested and the valve replacement surgery is carried out in the usual way.

Ethics approval

NHS Southmead Research Ethics Committee, 21/06/2006, ref: 06/Q2002/52

Study design

Parallel-group randomised controlled trial with equal allocation

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Coronary artery and valve disease

Intervention

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, following establishment of CPB, left ventricular venting will be conventionally achieved through the right superior pulmonary vein. CPB mean arterial pressure will be maintained at 75 mmHg to optimise myocardial perfusion of the empty beating heart during coronary surgery. Coronary grafting will be according to our reported method for beating heart coronary surgery.

For both groups cardioplegic arrest will be achieved with cold (4 - 6°C) intermittent antegrade and retrograde blood cardioplegia. In the conventional surgery group the heart will be arrested throughout the operation. For the hybrid group cardioplegic arrest will be instituted after completion of the coronary surgery.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measure

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

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

Overall trial start date

01/10/2007

Overall trial end date

01/10/2010

Reason abandoned (if study stopped)

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

160

Participant 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

Recruitment start date

01/10/2007

Recruitment end date

01/10/2010

Locations

Countries of recruitment

India, United Kingdom

Trial participating centre

Bristol Heart Institute
Bristol
BS2 8HW
United Kingdom

Sponsor information

Organisation

United Bristol NHS Healthcare Trust (UK)

Sponsor type

Government

Website

http://www.ubht.nhs.uk

Funders

Funder type