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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02285309
Other study ID # UCLondon
Secondary ID
Status Not yet recruiting
Phase N/A
First received November 4, 2014
Last updated November 4, 2014
Start date November 2014

Study information

Verified date November 2014
Source University College, London
Contact Bonnie Kyle
Phone 02034567898
Email bonniekyle@doctors.net.uk
Is FDA regulated No
Health authority United Kingdom: National Health Service
Study type Observational

Clinical Trial 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.


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 information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date
Est. primary completion date July 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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)

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Procedure:
Cardiac Surgery and enoximone
Does diastolic function change with cardiac surgery +/- enoximone

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University College, London

Outcome

Type Measure Description Time frame Safety issue
Primary Change in diastolic dysfunction -categorised as improved, stable or worse 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 Up to 12 hours No
Secondary Systolic and diastolic data from the post operative transthoracic echocardiogram Compare systolic and diastolic function on transthoracic echocardiography to intraoperative parameters Up to 30 days No
Secondary Duration of endotracheal intubation (in hours) How long patient remains intubated on ICU post operatively 0-30 days No
Secondary Incidence of post operative atrial fibrillation As above 0-30 days No
Secondary Duration of ICU stay As above 0-30 days No
Secondary Duration of hospital stay As above 0-30 days No
Secondary Cardiac Post Operatie Morbidity Score (C-POMS) As above 0-30 days No
Secondary 30 day Major Adverse Cardiovascular Events As above 0-30 days No
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