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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2008 by Newcastle-upon-Tyne Hospitals NHS Trust.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Newcastle-upon-Tyne Hospitals NHS Trust
ClinicalTrials.gov Identifier:
NCT00765349
First received: October 1, 2008
Last updated: NA
Last verified: September 2008
History: No changes posted
  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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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

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 August 19, 2014