Perioperative Measurements of Diastolic Function in Cardiac Surgery

Diastolic Dysfunction Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02285309
• Other study ID #: UCLondon
• 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. 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

• Diastolic Dysfunction

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