Predictors of Post Operative Outcome in Peripheral Vascular Surgical Patients

NCT01417910 | Completed

• 1 other identifier: PVD10
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Over 3000 people each year undergo bypass operations to their lower limbs, and these operations carry significant risks with approximately 1 in 20 of these people dying in hospital, and another 1 in 20 having a heart attack. Assessment of these patients in order to stratify their risk of both dying and having significant complications aid in improving their care, enable better utilisation of scarce critical care resources, and allow us to give patients better information on which to base consent. Aims The aims of the project are to assess the feasibility of exercise testing this group of patients both with cycle and arm exercise, and to identify markers of outcome in this group. Methodology This is a prospective observational study designed to test the hypothesis that a combination of cardiopulmonary exercise testing and blood tests provides prognostic value on outcome measures after surgery for lower limb revascularisation Subjects will have 2 exercise tests, one arm and one cycle, prior to surgery at their preoperative assessment appointment. From these tests we will measure how much work patients can do, how much oxygen they are able to use, and when the heart is unable to deliver enough oxygen to the cells. In addition they will have blood samples taken prior to the operation (brain natriuretic peptide), and on days 1 and 3 (troponin I) after the operation to look at cardiac markers of damage. This data will be used to see if we can predict those patients that have both short and long term complications, and also to see whether the different forms of exercise testing are comparable, or if one type is superior. Expected outcomes We expect that through a combination of exercise testing and blood test we will be able to identify patients at increased risk of complications after surgery. We also expect to find that arm exercise will be a more feasible and informative test that cycle exercise.

Conditions

Vascular Diseases

Outcome Measures

Primary Outcomes (1)

• 1 year all cause mortality

  1 year

Secondary Outcomes (7)

• 1 year major adverse cardiac event.

  1 year

• Morbidity as measured by the Post operative morbidity survey

  7 days

• major adverse cardiac event.

  participants will be followed for the duration of hospital stay, an expected median of 10 days

• 30 day all cause mortality.

  30 day

• Surgical post operative complications

  participants will be followed for the duration of hospital stay, an expected median of 10 days

Study Arms (1)

Peripheral vascular disease

Subjects who have peripheral vascular disease

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with peripheral vascular disease in a secondary care setting scheduled to undergo infra inguinal revascularisation.

You may qualify if:

• All patients undergoing elective and expedited infra inguinal peripheral revascularisation. Patients undergoing radiological assessment (angiography) and/or radiological intervention for peripheral vascular disease

You may not qualify if:

• Patients refusing to participate in the study or unable to give informed consent.

Sponsors & Collaborators

• York Teaching Hospitals NHS Foundation Trust: lead

Study Sites (1)

York Teaching Hospitals NHS Foundation Trust

York, North Yorkshire, YO318HE, United Kingdom

Location

MeSH Terms

Conditions

Vascular Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

• Simon J Davies, MBChB

  York Teaching Hospital NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2011
• First Posted: August 16, 2011
• Study Start: September 1, 2011
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: January 27, 2016

Record last verified: 2015-02

Locations

GB (1)