Efficacy of glyceryl trinitrate to facilitate the rewarming process during cardiopulmonary bypass

• Register: ISRCTN
• Last refreshed on: 24 August 2020
• Main ID: ISRCTN10480871
• Date of registration: 16/08/2017
• Prospective Registration: No
• Primary sponsor: Mater Misercordiae University Hospital
• Public title: Efficacy of glyceryl trinitrate to facilitate the rewarming process during cardiopulmonary bypass
• Scientific title: Efficacy of glyceryl trinitrate to facilitate the rewarming process during cardiopulmonary bypass: a prospective randomised trial
• Date of first enrolment: 30/01/2017
• Target sample size: 100
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN10480871
• Study type: Interventional
• Study design: Prospective randomised trial (Treatment)
• Phase: Not Applicable

Countries of recruitment

Ireland

Contacts

• Name: Darren Mullane

Key inclusion & exclusion criteria

Inclusion criteria:
1. Adult patients (aged over 18)
2. Capacity to consent
3. Undergoing cardiac surgery necessitating CPB

Exclusion criteria:
1. Age < 18 years old
2. Allergy to GTN
3. Cardiac surgery necessitation deep hypothermic circulatory arrest (DHCA)
4. Cardiac surgery not involving CPB (eg. off-pump cardiopulmonary bypass grafting)
5. Lack of capacity to consent
6. Use of TIVA propofol whilst on CPB


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Cardiac surgery necessitating CPB
Surgery

Intervention(s)

All patients scheduled to undergo cardiac surgery will be reviewed as per usual by the one of the cardiothoracic anaesthesia fellows, both of whom are part of the study team.

Patients, if eligible for the study, will be given a PIL and informed about the study. Following a cool off period to allow the patient time to consider their participation in the study if the patient wishes to participate in the study they will sign a consent form. At this point baseline patient details will be recorded.

Each study subject will be randomized via a computer randomization programme to either the low or high dose GTN infusion rate during rewarming prior to separation from cardiopulmonary bypass (approximately 30-minute duration).

Standard pre-operative assessment will be performed with recording of the following baseline demographics:
1. Patient age at surgery
2. Patient gender
3. Patient height, weight, BMI and body surface area
4. Planned surgery
5. Use of vasodilator therapy pre-operatively
6. Co-morbidities including presence of peripheral vascular disease and renal impairment
7. Left ventricular ejection fraction
8. EuroScore II

Patient induction and anaesthetic care will be as standard (as per the individual anaesthetizing consultant’s preference). Doses of all drugs administered during the surgical procedure will be recorded, as per standard practice. Invasive arterial pressure monitoring and central venous pressure monitoring lines will be placed as normal standard practice prior to knife to skin. All haemodynamic and temperature indices will be monitored continuousl

Primary Outcome(s)

1. Time to completion of rewarming prior to separation from CPB circuit
2. Early post-op patient peripheral – core temperature gradient
3. Time to maintenance of normothermia (core temperature > 36.5°C) for minimum of 2 hours in the initial post-op period and including skin temperature reaching a plateau
4. Plasma lactate concentrations initially post-CPB

Nasopharyngeal, skin and bladder temperature are recorded at baseline post induction of anaesthesia, rewarming from CPB, separation from CPB, application of surgical dressing (end of surgery) and arrival in ICU.

Secondary Outcome(s)

Time to extubation, measured from application of surgical dressing (end of surgery) to actual time of removal of endotracheal tube (extubation)

Secondary ID(s)

N/A

2017-002785-44

Source(s) of Monetary Support

Mater Misercordiae University Hospital

Ethics review

Status:
Approval date:
Contact:

Mater Misercordiae University Hospital Institutional Review Board, 18/01/2017, ref: 1/378/1869

Results

• Results available: Yes
• Date Completed: 14/08/2019