Perioperative Measurements of Diastolic Function in Cardiac Surgery

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

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.

Study Overview

• Status: Unknown
• Conditions: Diastolic Dysfunction
• Intervention / Treatment: Procedure: Cardiac Surgery and enoximone

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.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Bonnie Kyle; Phone Number: 02034567898; Email: bonniekyle@doctors.net.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Any cardiac surgery

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cardiac surgery	Procedure: Cardiac Surgery and enoximone; Does diastolic function change with cardiac surgery +/- enoximone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Duration of endotracheal intubation (in hours)	How long patient remains intubated on ICU post operatively	0-30 days
Incidence of post operative atrial fibrillation	As above	0-30 days
Duration of ICU stay	As above	0-30 days
Duration of hospital stay	As above	0-30 days
Cardiac Post Operatie Morbidity Score (C-POMS)	As above	0-30 days
30 day Major Adverse Cardiovascular Events	As above	0-30 days

Collaborators and Investigators

• Sponsor: University College, London

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Anticipated): July 1, 2015

Study Registration Dates

• First Submitted: November 4, 2014
• First Submitted That Met QC Criteria: November 4, 2014
• First Posted (Estimate): November 6, 2014

Study Record Updates

• Last Update Posted (Estimate): November 6, 2014
• Last Update Submitted That Met QC Criteria: November 4, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Keywords: Cardiac Surgery; Diastolic Dysfunction; Enoximone
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Enzyme Inhibitors; Protective Agents; Cardiotonic Agents; Phosphodiesterase Inhibitors; Phosphodiesterase 3 Inhibitors; Enoximone
• Other Study ID Numbers: UCLondon