Condition category
Respiratory
Date applied
25/04/2003
Date assigned
25/04/2003
Last edited
07/12/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.cesar-trial.org/

Contact information

Type

Scientific

Primary contact

Prof Diana Elbourne

ORCID ID

Contact details

Medical Statistics Unit
London School of Hygiene and Tropical Medicine
Keppel Street
London
WC1E 7HT
United Kingdom
+44 (0)20 7927 2629
diana.elbourne@lshtm.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 99/01/01

Study information

Scientific title

Acronym

CESAR

Study hypothesis

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

Not provided at time of registration

Study design

Multi-centre randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Respiratory tract diseases: Severe acute respiratory failure

Intervention

Conventional positive pressure ventilation vs. Extracorporeal Membrane Oxygenation (ECMO)

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/07/2000

Overall trial end date

31/12/2007

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

180

Participant 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

Recruitment start date

01/07/2000

Recruitment end date

31/12/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Medical Statistics Unit
London
WC1E 7HT
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom
+44 (0)1132 545 843
Sheila.Greener@doh.gsi.gov.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/en/index.htm

Funders

Funder type

Government

Funder name

NIHR Health Technology Assessment Programme - HTA (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2006 protocol in http://www.ncbi.nlm.nih.gov/pubmed/17187683
2. 2008 protocol in http://www.ncbi.nlm.nih.gov/pubmed/18447931
3. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19762075
4. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20642916

Publication citations

  1. Results

    Peek GJ, Elbourne D, Mugford M, Tiruvoipati R, Wilson A, Allen E, Clemens F, Firmin R, Hardy P, Hibbert C, Jones N, Killer H, Thalanany M, Truesdale A, Randomised controlled trial and parallel economic evaluation of conventional ventilatory support versus extracorporeal membrane oxygenation for severe adult respiratory failure (CESAR)., Health Technol Assess, 2010, 14, 35, 1-46, doi: 10.3310/hta14350.

  2. Peek GJ, Clemens F, Elbourne D, Firmin R, Hardy P, Hibbert C, Killer H, Mugford M, Thalanany M, Tiruvoipati R, Truesdale A, Wilson A, CESAR: conventional ventilatory support vs extracorporeal membrane oxygenation for severe adult respiratory failure., BMC Health Serv Res, 2006, 6, 163, doi: 10.1186/1472-6963-6-163.

  3. Thalanany MM, Mugford M, Hibbert C, Cooper NJ, Truesdale A, Robinson S, Tiruvoipati R, Elbourne DR, Peek GJ, Clemens F, Hardy P, Wilson A, , Methods of data collection and analysis for the economic evaluation alongside a national, multi-centre trial in the UK: conventional ventilation or ECMO for Severe Adult Respiratory Failure (CESAR)., BMC Health Serv Res, 2008, 8, 94, doi: 10.1186/1472-6963-8-94.

  4. Peek GJ, Mugford M, Tiruvoipati R, Wilson A, Allen E, Thalanany MM, Hibbert CL, Truesdale A, Clemens F, Cooper N, Firmin RK, Elbourne D, , Efficacy and economic assessment of conventional ventilatory support versus extracorporeal membrane oxygenation for severe adult respiratory failure (CESAR): a multicentre randomised controlled trial., Lancet, 2009, 374, 9698, 1351-1363, doi: 10.1016/S0140-6736(09)61069-2.

Additional files

Editorial Notes