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ISRCTN
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ISRCTN47279827
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ClinicalTrials.gov identifier
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Public title
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CESAR (conventional ventilatory support versus extracorporeal membrane oxygenation for severe adult respiratory failure)
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Scientific title
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Acronym
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CESAR
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Serial number at source
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HTA 99/01/01
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Study hypothesis
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The objective of this study is to test the hypotheses that, for patients with severe but potentially reversible respiratory failure, extracorporeal membrane oxygenation ECMO:
1. Will increase the rate of survival without severe disability by six months post randomisation.
2. Will be cost effective, compared to conventional ventilatory support.
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Ethics approval
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Not provided at time of registration
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Study design
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Multi-centre randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Respiratory tract diseases: Severe acute respiratory failure
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Participants - inclusion criteria
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1. Adult patients (18-65 years in UK)
2. With severe, but potentially reversible respiratory failure. Severe respiratory failure will be defined as a Murray score >3.0, or uncompensated hypercapnoea with a pH <7.20
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Participants - exclusion criteria
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1. Duration of high pressure and/or high FiO2 ventilation >7 days
2. Intra-cranial bleeding
3. Any other contra-indication to limited heparinisation
4. Patients who are moribund and have any contra-indication to continuation of active treatment
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Anticipated start date
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01/07/2000
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Anticipated end date
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31/12/2007
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Status of trial
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Completed
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Patient information material
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Target number of participants
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180
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Interventions
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Conventional positive pressure ventilation vs. Extracorporeal Membrane Oxygenation (ECMO)
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Primary outcome measure(s)
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Death or severe disability at six months. Severe disability will be defined as requiring full time nursing care at home, or continued residence in hospital.
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Secondary outcome measure(s)
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1. Hospital Indices: duration of ventilation, length of ITU stay, length of hospital stay. Daily APACHE II score. In addition, data will be collected on ventilator settings, arterial blood gases, total intake minus output excluding blood loss and replacement, weight, full nutrition, haemoglobin, white blood cell count, blood products administered, prone position, nitric oxide, creatinine, bilirubin and maximum temperature. For ECMO patients only, data will be collected on mode (VV/VA), blood flow and sweep flow.
2. Follow up: Survivors will be contacted 6 months after randomisation for a detailed domicillary by a chest physician using a structured data collection form. Patients (or their carers, if necessary) will also complete questionnaires, assessment using standard scales to assess their activities of daily living, respiratory symptoms and psychological state.
Economic issues: The trial will assess the cost of treatment to the health and social services and to patients and their families in each treatment group. An incremental cost-effectiveness ratio will be calculated and compared to that for similar life-extending treatments. Information for the costs of inpatient and domicillary care will be collected using methods adapted from the neonatal ECMO Trial.
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Sources of funding
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NIHR Health Technology Assessment Programme - HTA (UK)
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Trial website
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http://www.cesar-trial.org/
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Publications
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Contact name
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Prof
Diana
Elbourne
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Address
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Medical Statistics Unit
London School of Hygiene and Tropical Medicine
Keppel Street
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City/town
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London
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Zip/Postcode
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WC1E 7HT
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Country
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United Kingdom
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Tel
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+44 (0)20 7927 2629
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Fax
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+44 (0)20 7637 2853
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Email
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diana.elbourne@lshtm.ac.uk
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Sponsor
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Department of Health (UK)
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Address
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Quarry House
Quarry Hill
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City/town
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Leeds
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Zip/Postcode
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LS2 7UE
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Country
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United Kingdom
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Email
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Sheila.Greener@doh.gsi.gov.uk
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Sponsor website:
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http://www.dh.gov.uk/en/index.htm
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Date applied
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25/04/2003
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Last edited
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15/01/2008
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Date ISRCTN assigned
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25/04/2003
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