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Predictors of Post Operative Outcome in Peripheral Vascular Surgical Patients

26. januar 2016 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

100

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • North Yorkshire
      • York, North Yorkshire, Det Forenede Kongerige, YO318HE
        • York Teaching Hospitals NHS Foundation Trust

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 99 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Peripheral vascular disease
Subjects who have peripheral vascular disease

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
1 year all cause mortality
Tidsramme: 1 year
1 year

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
1 year major adverse cardiac event.
Tidsramme: 1 year
1 year
Morbidity as measured by the Post operative morbidity survey
Tidsramme: 7 days
7 days
major adverse cardiac event.
Tidsramme: 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.
Tidsramme: 30 day
30 day
Surgical post operative complications
Tidsramme: 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
Tidsramme: 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.
Tidsramme: 0,6 and 12 months
0,6 and 12 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Simon J Davies, MBChB, York Teaching Hospital NHS Foundation Trust

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. september 2011

Primær færdiggørelse (Faktiske)

1. oktober 2014

Studieafslutning (Faktiske)

1. oktober 2014

Datoer for studieregistrering

Først indsendt

1. august 2011

Først indsendt, der opfyldte QC-kriterier

15. august 2011

Først opslået (Skøn)

16. august 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

27. januar 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

26. januar 2016

Sidst verificeret

1. februar 2015

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • PVD10

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