Perioperative Measurements of Diastolic Function in Cardiac Surgery
- Conditions
- Diastolic Dysfunction
- Interventions
- Procedure: Cardiac Surgery and enoximone
- Registration Number
- NCT02285309
- Lead Sponsor
- University College, London
- Brief Summary
This observational clinical trial will investigate the following perioperative indices relating to cardiac surgery:
1. The significance of measurements involving left heart relaxation (LV diastolic function) and its relation to outcome measures.
2. The significance of measurements involving right heart relaxation function and itrs relation to outcome measures.
3. The influence of drugs such as enoximone on these outcome measures.
- Detailed Description
Over the past two decades, perioperative TOE has become routine part of monitoring in the setting of cardiac surgery. In many centres around the world nearly 100% of pateints undergoing cardiac surgery are monitored using this modality. There are several studies and observational reviews suggesting intraoperative TOE can change management and thus indirectly influence outcome in patients undergoing valve, aortic or bypass graft surgery. Certainly in our centre at The Heart Hospital, it is routine practce to perform an intraoperative TOE in all patients undergoing cardiac surgery in order to guide surgical and anaesthetic management of the patient. Despite this use of TOE there is very little evidence of how TOE influences patient related outcomes, both morbidity and mortality.
Several advances have occurred over the years involving both better technology to image the heart with TOE along with the development of novel measurements of heart function. As technology has evolved, many modalities and measurement have not been validated in the setting of cardiac surgery. In our observational clincal trial we aim to investigate the following:
1. The significance of measurements involving left heart relaxation (LV diastolic function) and its relation to outcome measures.
2. The significance of measurements involving the right heart relaxation function and itrs relation to outcome measures.
3. The influence of drugs such as enoximone on these outcome measures.
While many of these measurements have been validated in the care of medical patients, they have not been examined in the surgical setting. In addition, its ability to predict outcome has never been tested. We believe this study will help us answer these important questions.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 100
- Systolic dysfunction (EF <50%) or diastolic dysfunction grade 1-3 as determined through preoperative TTE or intraoperative TOE
- Able to give informed consent
- Contraindication to transoesphageal echocardiography (such as previous oesophagectomy)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Cardiac surgery Cardiac Surgery and enoximone -
- Primary Outcome Measures
Name Time Method Change in diastolic dysfunction -categorised as improved, stable or worse Up to 12 hours Compare diastolic dysfunction before and after surgery in those that receive enoximone. Compare diastolic function before and after surgery in those that do not receive enoximone
- Secondary Outcome Measures
Name Time Method Duration of endotracheal intubation (in hours) 0-30 days How long patient remains intubated on ICU post operatively
Duration of ICU stay 0-30 days As above
Cardiac Post Operatie Morbidity Score (C-POMS) 0-30 days As above
Incidence of post operative atrial fibrillation 0-30 days As above
Systolic and diastolic data from the post operative transthoracic echocardiogram Up to 30 days Compare systolic and diastolic function on transthoracic echocardiography to intraoperative parameters
30 day Major Adverse Cardiovascular Events 0-30 days As above
Duration of hospital stay 0-30 days As above