Clinical Observational Study Investigating the Role of Diastolic Dysfunction in Determining Abnormal Cardiorespiratory Exercise Testing Parameters in Patients Undergoing Major Surgery
Recruitment status was Recruiting
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Purpose
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
- 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
- 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
- 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.
| Condition |
|---|
|
Diastolic Dysfunction |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Estimated Enrollment: | 30 |
| Study Start Date: | May 2008 |
| Groups/Cohorts |
|---|
| All patients undergoing major surgery |
Eligibility| Ages Eligible for Study: | 65 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Patients undergoing major elective surgery
Inclusion Criteria:
- Patients undergoing major surgery
- Low functional capacity
Exclusion Criteria:
- Unable to give consent
Contacts and Locations| Contact: james prentis, mbbs | 0191 4602958 | jamesprentis@btinternet.com |
| Contact: chris snowden, mbbs | 01912336161 ext 31306 | chris.snowden@nuth.nhs.uk |
| United Kingdom | |
| Freeman Hospital | Recruiting |
| Newcastle Upon Tyne, Tyne and Wear, United Kingdom, NE7 7DN | |
| Contact: James ` Prentis, MBBS 01914602958 jamesprentis@btinternet.com | |
| Principal Investigator: James Prentis, MBBS | |
More Information
No publications provided
| Responsible Party: | Research and development department, Newcastle Hospitals NHS Trust |
| ClinicalTrials.gov Identifier: | NCT00765349 History of Changes |
| Other Study ID Numbers: | 08/H0902/11 |
| Study First Received: | October 1, 2008 |
| Last Updated: | October 1, 2008 |
| Health Authority: | United Kingdom: Research Ethics Committee United Kingdom: National Health Service |
ClinicalTrials.gov processed this record on May 16, 2013