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Predictors of Post Operative Outcome in Peripheral Vascular Surgical Patients

26 janvier 2016 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Description détaillée

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.

Type d'étude

Observationnel

Inscription (Réel)

100

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

    • North Yorkshire
      • York, North Yorkshire, Royaume-Uni, YO318HE
        • York Teaching Hospitals NHS Foundation Trust

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 99 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

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

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Cohortes et interventions

Groupe / Cohorte
Peripheral vascular disease
Subjects who have peripheral vascular disease

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Délai
1 year all cause mortality
Délai: 1 year
1 year

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
1 year major adverse cardiac event.
Délai: 1 year
1 year
Morbidity as measured by the Post operative morbidity survey
Délai: 7 days
7 days
major adverse cardiac event.
Délai: 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.
Délai: 30 day
30 day
Surgical post operative complications
Délai: 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
Délai: 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.
Délai: 0,6 and 12 months
0,6 and 12 months

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Les enquêteurs

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

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 septembre 2011

Achèvement primaire (Réel)

1 octobre 2014

Achèvement de l'étude (Réel)

1 octobre 2014

Dates d'inscription aux études

Première soumission

1 août 2011

Première soumission répondant aux critères de contrôle qualité

15 août 2011

Première publication (Estimation)

16 août 2011

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

27 janvier 2016

Dernière mise à jour soumise répondant aux critères de contrôle qualité

26 janvier 2016

Dernière vérification

1 février 2015

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • PVD10

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