Clinical Observational Study Investigating the Role of Diastolic Dysfunction in Determining Abnormal Cardiorespiratory Exercise Testing Parameters in Patients Undergoing Major Surgery

Diastolic Dysfunction Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00765349
• Other study ID #: 08/H0902/11
• Status: Recruiting
• Phase: N/A
• First received: October 1, 2008
• Last updated: October 7, 2015
• Start date: May 2008

Study information

• Verified date: October 2015
• Source: Newcastle-upon-Tyne Hospitals NHS Trust
• Contact: james prentis, mbbs
• Phone: 0191 4602958
• Email: jamesprentis[@]btinternet.com
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics CommitteeUnited Kingdom: National Health Service
• Study type: Observational

Clinical Trial Summary

REASON FOR STUDY

Major non-cardiac surgery has a high degree of morbidity and mortality. Recently, suitable measurements of a patient's preoperative cardiorespiratory reserve, performed non-invasively by cardiopulmonary exercise testing, have been shown to be predictive of outcome following non-cardiac surgery. Although the exact mechanisms behind poor reserve in this population are unknown, poor cardiac function and particularly diastolic dysfunction are likely to be important.

AIMS

The aim of the present study is to investigate the role of diastolic dysfunction in determining poor cardiorespiratory reserve in elderly patients undergoing major non-cardiac surgery. This will provide suitable information to inform a further therapeutic preoperative interventional study.

OBJECTIVES AND METHODS

1. To determine the presence and severity of diastolic dysfunction, measured by preoperative transthoracic echocardiogram, in a series of elderly surgical patients undergoing major elective non-cardiac surgery

2. To investigate the relationship between diastolic dysfunction and poor cardiorespiratory function during and following exercise measured by non-invasive testing including cardiopulmonary exercise testing, non-invasive blood pressure measurements and biochemical analysis

3. To determine whether patients with poor diastolic dysfunction are likely to have worse outcomes following major surgery compared with those who show no evidence of diastolic dysfunction. Outcomes will be measured in terms of length of hospital stay and early postoperative morbidity (validated scoring system) and mortality.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Patients undergoing major surgery

• Low functional capacity

Exclusion Criteria:

• Unable to give consent

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diastolic Dysfunction

Locations

Country	Name	City	State
United Kingdom	Freeman Hospital	Newcastle Upon Tyne	Tyne and Wear

Sponsors (1)

Lead Sponsor	Collaborator
Newcastle-upon-Tyne Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom,