Perioperative Measurements of Diastolic Function in Cardi... | NCT02285309

Studies
Perioperative Measurements of Diastolic Function in Cardiac Surgery

NCT02285309

Sponsor

University College, London

Status

Unknown status

Last Update Posted

Nov 6, 2014Estimated

Enrollment

100Estimated

Phase

Not provided

Conditions

Diastolic Dysfunction

Interventions

Cardiac Surgery and enoximone

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2014

Primary Completion Date

Jul 2015Estimated

Completion Date

Not provided

First Submitted Date

Nov 4, 2014

First Submission Date that Met QC Criteria

Nov 4, 2014

First Posted Date

Nov 6, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 4, 2014

Last Update Posted Date

Nov 6, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This observational clinical trial will investigate the following perioperative indices relating to cardiac surgery:

The significance of measurements involving left heart relaxation (LV diastolic function) and its relation to outcome measures.
The significance of measurements involving right heart relaxation function and itrs relation to outcome measures.
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:

The significance of measurements involving left heart relaxation (LV diastolic function) and its relation to outcome measures.
The significance of measurements involving the right heart relaxation function and itrs relation to outcome measures.
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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cardiac surgery			Procedure: Cardiac Surgery and enoximone

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cardiac Surgery and enoximone	Procedure	Does diastolic function change with cardiac surgery +/- enoximone	Cardiac surgery

Outcomes Module

Primary Outcomes

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 Outcomes

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)

Other Outcomes

Not provided

Eligibility Module

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Any cardiac surgery

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Bonnie Kyle	Contact	02034567898		bonniekyle@doctors.net.uk

Overall Officials

Not provided

Locations

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D006348	Cardiac Surgical Procedures
D017335	Enoximone

Ancestor Terms

ID	Term
D013504	Cardiovascular Surgical Procedures
D013514	Surgical Procedures, Operative
D019616	Thoracic Surgical Procedures
D007093	Imidazoles

Browse Leaves

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Browse Branches

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