Shortening cardioplegic arrest time during combined coronary and valvular surgery

ISRCTN	ISRCTN65770930
DOI	https://doi.org/10.1186/ISRCTN65770930
Secondary identifying numbers	CS/2006/2267 (Sponsor's reference number)

Submission date: 20/04/2007
Registration date: 13/06/2007
Last edited: 27/04/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Raimondo Ascione
Scientific

Bristol Heart Institute
University of Bristol
Level 7, Bristol Royal Infirmary
Marlborough Street
Bristol
BS2 8HW
United Kingdom

Phone	+44 (0)117 928 3145
Email	r.ascione@bristol.ac.uk

Study information

Study design	Parallel-group randomised controlled trial with equal allocation
Primary study design	Interventional
Secondary study design	Randomised parallel trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use contact details to request a participant information sheet
Scientific title	Shortening Cardioplegic Arrest Time during combined coronary and valvular surgery
Study acronym	SCAT
Study objectives	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(s)	NHS Southmead Research Ethics Committee, 21/06/2006, ref: 06/Q2002/52
Health condition(s) or problem(s) studied	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
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 study start date	01/10/2007
Completion date	01/10/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	160
Key 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
Key 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
Date of first enrolment	01/10/2007
Date of final enrolment	01/10/2010

Locations

Countries of recruitment

England
India
United Kingdom

Study participating centre

Bristol Heart Institute

Bristol
BS2 8HW
United Kingdom

Sponsor information

United Bristol NHS Healthcare Trust (UK)
Hospital/treatment centre

UBHT Research and Effectiveness Department
Bristol Royal Infirmary
Marlborough Street
Bristol
BS2 8HW
England
United Kingdom

Phone	+44 (0)117 928 3473
Email	debbie.mcphee@ubht.nhs.uk
Website	http://www.ubht.nhs.uk
"ROR"	https://ror.org/04nm1cv11

Funders

Funder type

Government

National Institute for Health Research (NIHR) (UK) - Biomedical Research Centre Programme
Government organisation / National government

Alternative name(s): National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/08/2017		Yes	No

Editorial Notes

27/04/2017: Publication reference added.