Predictors of Post Operative Outcome in Peripheral Vascular Surgical Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by York Teaching Hospitals NHS Foundation Trust
Sponsor:
Information provided by (Responsible Party):
York Teaching Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01417910
First received: August 1, 2011
Last updated: May 15, 2014
Last verified: May 2014
  Purpose

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.


Condition
Vascular Diseases

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prognostic Markers of Outcome in Patients Undergoing Infra-inguinal Revascularisation. A Prospective Observational Study.

Resource links provided by NLM:


Further study details as provided by York Teaching Hospitals NHS Foundation Trust:

Primary Outcome Measures:
  • 1 year all cause mortality [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 1 year major adverse cardiac event. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Morbidity as measured by the Post operative morbidity survey [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • major adverse cardiac event. [ Time Frame: participants will be followed for the duration of hospital stay, an expected median of 10 days ] [ Designated as safety issue: No ]
  • 30 day all cause mortality. [ Time Frame: 30 day ] [ Designated as safety issue: No ]
  • Surgical post operative complications [ Time Frame: participants will be followed for the duration of hospital stay, an expected median of 10 days ] [ Designated as safety issue: No ]
    participants will be followed for the duration of hospital stay, an expected median of 10 days

  • Medical post operative complications [ Time Frame: participants will be followed for the duration of hospital stay, an expected median of 10 days ] [ Designated as safety issue: No ]
    participants will be followed for the duration of hospital stay, an expected median of 10 days

  • Quality of life measured at 6 and 12 months postoperatively by the EQ-5D-5L questionnaire. [ Time Frame: 0,6 and 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: September 2011
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Peripheral vascular disease
Subjects who have peripheral vascular disease

Detailed Description:

Background 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. The number of people having this type of procedure has grown over recent years and the trend is predicted to continue. Due to this significant increase in the volume of these patients, and the associated complications that occur with this surgery, utilisation of more resources such as critical care is often needed.

Assessment of these patients in order to stratify their risk of both dying and having significant complications aid in improving their care, allow better utilisation of scarce critical care resources, and also allow us to provide patients with better information as part of the informed consent process.

A high risk group in major abdominal surgery can be identified through a simple exercise test (cardiopulmonary exercise test) that looks at how the body uses oxygen, and also through a blood test that look at a hormone secreted by the heart. Vascular surgical patients are at risk for the development of major cardiac complications in the postoperative period but a system for appropriate preoperative risk stratifications has yet to be achieved.

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. Identification of markers that can predict how patients will fare after surgery will allow us to improve the informed consent process, utilise resources more effectively and efficiently and identify opportunities to attempt to modify outcomes.

Methodology This is a prospective observational study designed to test the hypothesis that a combination of cardiopulmonary exercise testing and blood tests provide prognostic value on outcome measures after surgery for lower limb revascularisation.

Participants 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 a 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.

Implications Identification of a high risk group would allow appropriate strategies to be implemented to reduce risk, and allow better post-operative resource utilisation. This study will also allow a larger multicentre study to be adequately powered and constructed.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients refusing to participate in the study or unable to give informed 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: NCT01417910

Contacts
Contact: Simon J Davies, MBChB 01904631313 simon.davies@york.nhs.uk

Locations
United Kingdom
York Teaching Hospitals NHS Foundation Trust Recruiting
York, North Yorkshire, United Kingdom, YO318HE
Principal Investigator: Simon J Davies, MBChB         
Sponsors and Collaborators
York Teaching Hospitals NHS Foundation Trust
Investigators
Principal Investigator: Simon J Davies, MBChB York Teaching Hospital NHS Foundation Trust
  More Information

No publications provided

Responsible Party: York Teaching Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01417910     History of Changes
Other Study ID Numbers: PVD10
Study First Received: August 1, 2011
Last Updated: May 15, 2014
Health Authority: United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 16, 2014