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Clinical Observational Study Investigating the Role of Diastolic Dysfunction in Determining Abnormal Cardiorespiratory Exercise Testing Parameters in Patients Undergoing Major Surgery
This study is currently recruiting participants.
Verified by Newcastle-upon-Tyne Hospitals NHS Trust, September 2008
Sponsored by: Newcastle-upon-Tyne Hospitals NHS Trust
Information provided by: Newcastle-upon-Tyne Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT00765349
  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

  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.

Condition
Diastolic Dysfunction

MedlinePlus related topics: Exercise and Physical Fitness
U.S. FDA Resources
Study Type: Observational
Study Design: Cohort, Prospective

Further study details as provided by Newcastle-upon-Tyne Hospitals NHS Trust:

Biospecimen Retention:   None Retained

Biospecimen Description:

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
Study Population

Patients undergoing major elective surgery

Criteria

Inclusion Criteria:

  • Patients undergoing major surgery
  • Low functional capacity

Exclusion Criteria:

  • Unable to give consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00765349

Contacts
Contact: james prentis, mbbs 0191 4602958 jamesprentis@btinternet.com
Contact: chris snowden, mbbs 01912336161 ext 31306 chris.snowden@nuth.nhs.uk

Locations
United Kingdom, Tyne and Wear
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            
Sponsors and Collaborators
Newcastle-upon-Tyne Hospitals NHS Trust
  More Information

Responsible Party: Newcastle Hospitals NHS Trust ( Research and development department )
Study ID Numbers: 08/H0902/11
Study First Received: October 1, 2008
Last Updated: October 1, 2008
ClinicalTrials.gov Identifier: NCT00765349  
Health Authority: United Kingdom: Research Ethics Committee;   United Kingdom: National Health Service

ClinicalTrials.gov processed this record on January 13, 2009