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Predictors of Post Operative Outcome in Peripheral Vascular Surgical Patients

26. ledna 2016 aktualizováno: 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.

Přehled studie

Postavení

Dokončeno

Detailní popis

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.

Typ studie

Pozorovací

Zápis (Aktuální)

100

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

    • North Yorkshire
      • York, North Yorkshire, Spojené království, YO318HE
        • York Teaching Hospitals NHS Foundation Trust

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let až 99 let (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Metoda odběru vzorků

Vzorek nepravděpodobnosti

Studijní populace

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

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Kohorty a intervence

Skupina / kohorta
Peripheral vascular disease
Subjects who have peripheral vascular disease

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Časové okno
1 year all cause mortality
Časové okno: 1 year
1 year

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
1 year major adverse cardiac event.
Časové okno: 1 year
1 year
Morbidity as measured by the Post operative morbidity survey
Časové okno: 7 days
7 days
major adverse cardiac event.
Časové okno: 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.
Časové okno: 30 day
30 day
Surgical post operative complications
Časové okno: 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
Časové okno: 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.
Časové okno: 0,6 and 12 months
0,6 and 12 months

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Vyšetřovatelé

  • Vrchní vyšetřovatel: Simon J Davies, MBChB, York Teaching Hospital NHS Foundation Trust

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia

1. září 2011

Primární dokončení (Aktuální)

1. října 2014

Dokončení studie (Aktuální)

1. října 2014

Termíny zápisu do studia

První předloženo

1. srpna 2011

První předloženo, které splnilo kritéria kontroly kvality

15. srpna 2011

První zveřejněno (Odhad)

16. srpna 2011

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Odhad)

27. ledna 2016

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

26. ledna 2016

Naposledy ověřeno

1. února 2015

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • PVD10

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