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Predictors of Post Operative Outcome in Peripheral Vascular Surgical Patients

26 de janeiro de 2016 atualizado por: York Teaching Hospitals NHS Foundation Trust

Prognostic Markers of Outcome in Patients Undergoing Infra-inguinal Revascularisation. A Prospective Observational Study.

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.

Visão geral do estudo

Status

Concluído

Condições

Descrição detalhada

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.

Tipo de estudo

Observacional

Inscrição (Real)

100

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

    • North Yorkshire
      • York, North Yorkshire, Reino Unido, YO318HE
        • York Teaching Hospitals NHS Foundation Trust

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos a 99 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Método de amostragem

Amostra Não Probabilística

População do estudo

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

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Coortes e Intervenções

Grupo / Coorte
Peripheral vascular disease
Subjects who have peripheral vascular disease

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Prazo
1 year all cause mortality
Prazo: 1 year
1 year

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
1 year major adverse cardiac event.
Prazo: 1 year
1 year
Morbidity as measured by the Post operative morbidity survey
Prazo: 7 days
7 days
major adverse cardiac event.
Prazo: participants will be followed for the duration of hospital stay, an expected median of 10 days
participants will be followed for the duration of hospital stay, an expected median of 10 days
30 day all cause mortality.
Prazo: 30 day
30 day
Surgical post operative complications
Prazo: participants will be followed for the duration of hospital stay, an expected median of 10 days
participants will be followed for the duration of hospital stay, an expected median of 10 days
participants will be followed for the duration of hospital stay, an expected median of 10 days
Medical post operative complications
Prazo: participants will be followed for the duration of hospital stay, an expected median of 10 days
participants will be followed for the duration of hospital stay, an expected median of 10 days
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.
Prazo: 0,6 and 12 months
0,6 and 12 months

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Investigadores

  • Investigador principal: Simon J Davies, MBChB, York Teaching Hospital NHS Foundation Trust

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo

1 de setembro de 2011

Conclusão Primária (Real)

1 de outubro de 2014

Conclusão do estudo (Real)

1 de outubro de 2014

Datas de inscrição no estudo

Enviado pela primeira vez

1 de agosto de 2011

Enviado pela primeira vez que atendeu aos critérios de CQ

15 de agosto de 2011

Primeira postagem (Estimativa)

16 de agosto de 2011

Atualizações de registro de estudo

Última Atualização Postada (Estimativa)

27 de janeiro de 2016

Última atualização enviada que atendeu aos critérios de controle de qualidade

26 de janeiro de 2016

Última verificação

1 de fevereiro de 2015

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • PVD10

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