CESAR: Conventional ventilatory support versus extracorporeal membrane oxygenation for severe adult respiratory failure

ISRCTN	ISRCTN47279827
DOI	https://doi.org/10.1186/ISRCTN47279827
Protocol serial number	HTA 99/01/01
Sponsor	Department of Health (UK)
Funder	NIHR Health Technology Assessment Programme - HTA (UK)

Submission date: 25/04/2003
Registration date: 25/04/2003
Last edited: 07/12/2010

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Respiratory

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Diana Elbourne
Scientific

Medical Statistics Unit
London School of Hygiene and Tropical Medicine
Keppel Street
London
WC1E 7HT
United Kingdom

Phone	+44 (0)20 7927 2629
Email	diana.elbourne@lshtm.ac.uk

Study information

Primary study design	Interventional
Study design	Multi-centre randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	CESAR
Study objectives	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.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Respiratory tract diseases: Severe acute respiratory failure
Intervention	Conventional positive pressure ventilation vs. Extracorporeal Membrane Oxygenation (ECMO)
Intervention type	Other
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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.
Completion date	31/12/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	65 Years
Sex	All
Target sample size at registration	180
Key inclusion criteria	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
Key exclusion criteria	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
Date of first enrolment	01/07/2000
Date of final enrolment	31/12/2007

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Medical Statistics Unit

London
WC1E 7HT
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	17/10/2009		Yes	No
Results article	results	01/07/2010		Yes	No
Protocol article	protocol	23/12/2006		Yes	No
Protocol article	protocol	30/04/2008		Yes	No
Study website	Study website	11/11/2025	11/11/2025	No	Yes