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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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02285309
Enrollment
100
Registered
2014-11-06
Start date
2014-11-30
Completion date
Unknown
Last updated
2014-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diastolic Dysfunction

Keywords

Cardiac Surgery, Diastolic Dysfunction, Enoximone

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.

Interventions

PROCEDURECardiac Surgery and enoximone

Does diastolic function change with cardiac surgery +/- enoximone

Sponsors

University College, London
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Change in diastolic dysfunction -categorised as improved, stable or worseUp to 12 hoursCompare 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

MeasureTime frameDescription
Duration of endotracheal intubation (in hours)0-30 daysHow long patient remains intubated on ICU post operatively
Incidence of post operative atrial fibrillation0-30 daysAs above
Duration of ICU stay0-30 daysAs above
Systolic and diastolic data from the post operative transthoracic echocardiogramUp to 30 daysCompare systolic and diastolic function on transthoracic echocardiography to intraoperative parameters
Cardiac Post Operatie Morbidity Score (C-POMS)0-30 daysAs above
30 day Major Adverse Cardiovascular Events0-30 daysAs above
Duration of hospital stay0-30 daysAs above

Contacts

Primary ContactBonnie Kyle
bonniekyle@doctors.net.uk02034567898

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026