CESAR: Conventional ventilatory support versus extracorporeal membrane oxygenation for severe adult respiratory failure
| ISRCTN | ISRCTN47279827 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN47279827 |
| Secondary identifying numbers | HTA 99/01/01 |
- 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
Scientific
Medical Statistics Unit
London School of Hygiene and Tropical Medicine
Keppel Street
London
WC1E 7HT
United Kingdom
| Phone | +44 (0)20 7927 2629 |
|---|---|
| diana.elbourne@lshtm.ac.uk |
Study information
| Study design | Multi-centre randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| 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 | 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. |
| Secondary outcome measures | 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. |
| Overall study start date | 01/07/2000 |
| 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 number of participants | 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
- England
- United Kingdom
Study participating centre
Medical Statistics Unit
London
WC1E 7HT
United Kingdom
WC1E 7HT
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom
| Phone | +44 (0)1132 545 843 |
|---|---|
| Sheila.Greener@doh.gsi.gov.uk | |
| Website | http://www.dh.gov.uk/en/index.htm |
"ROR" |
https://ror.org/03sbpja79 |
Funders
Funder type
Government
NIHR Health Technology Assessment Programme - HTA (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 23/12/2006 | Yes | No | |
| Protocol article | protocol | 30/04/2008 | Yes | No | |
| Results article | results | 17/10/2009 | Yes | No | |
| Results article | results | 01/07/2010 | Yes | No |
