Clinical trial NCT02285309: Perioperative Measurements of Diastolic Function in Cardiac Surgery
Official title: The Utility of Novel Measurements of Diastolic Function Involving Transoesophageal and Transthoracic Echocardiography in the Peri-operative Period in Patients Undergoing Cardiac Surgery -an Exploratory Trial
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diastolic Dysfunction
Keywords: Cardiac Surgery
Diastolic Dysfunction
Enoximone
Lead sponsor: University College, London
Sponsor class: OTHER
First posted: 2014-11-06
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any cardiac surgery

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.

Eligibility criteria: Inclusion Criteria:

* Systolic dysfunction (EF \<50%) or diastolic dysfunction grade 1-3 as determined through preoperative TTE or intraoperative TOE
* Able to give informed consent

Exclusion Criteria:

* Contraindication to transoesphageal echocardiography (such as previous oesophagectomy)

Primary outcomes:
measure: Change in diastolic dysfunction -categorised as improved, stable or worse
timeFrame: Up to 12 hours
Secondary outcomes:
measure: Systolic and diastolic data from the post operative transthoracic echocardiogram
timeFrame: Up to 30 days
measure: Duration of endotracheal intubation (in hours)
timeFrame: 0-30 days
measure: Incidence of post operative atrial fibrillation
timeFrame: 0-30 days
measure: Duration of ICU stay
timeFrame: 0-30 days
measure: Duration of hospital stay
timeFrame: 0-30 days
measure: Cardiac Post Operatie Morbidity Score (C-POMS)
timeFrame: 0-30 days
measure: 30 day Major Adverse Cardiovascular Events
timeFrame: 0-30 days
Other outcomes:
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