Condition category
Respiratory
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
08/02/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr D Thickett

ORCID ID

Contact details

Respiratory Medicine
Queen Elizabeth Hospital
Birmingham
B15 2TH
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0265109355

Study information

Scientific title

Acronym

Study hypothesis

Does routine quantitative culture of BronchoAlveolar Lavage (BAL) improve delivery of care and functionally important outcomes in Acute Lung Injury (ALI)/Acute Respiratory Distress Syndrome (ARDS)?

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Respiratory: Acute Respiratory Distress Syndrome (ARDS) + Acute Lung Injury (ALI)

Intervention

1. Identify patients suitable for inclusion into study
2. Seek consultant assent (not one of the investigators) to enter patient into study
3. Randomise to quantitative or non-quantitative culture
4. Day one to two BronchoAlveolar Lavage (BAL) and peripheral blood sample (50 ml arterial blood, 5 ml venous blood)
5. Day four to six BAL and blood (l0 ml)
6. Day seven to nine BAL and blood (l0 ml)
7. Day 12 to 14 BAL and blood (l0 ml)
8. Weekly BAL and blood sampling thereafter. Sampling protocol based on evidence which shows that approximately 80% of episodes of Ventilator-Associated Pneumonia (VAP) occur in the first two weeks of invasive ventilation (Markowicz P, Wolff M, Djedaini K, et al: Multicenter prospective study of ventilator-associated pneumonia during ARDS. Am J Respir Crit Care Med 2000, 161:1942-1948).
9. Retrospective consent to take part in study, and to use retained specimens for research. Several models of consent have been applied to patients receiving intensive care. All, however, contain difficult issues regarding the competency of these patients to give informed consent at the proposed point of enrolment into the study. Following discussion with Dr C Counsell (R&D Support), we propose that Bronchoscopy/BAL is in the best interests of patients as it provides the best method of obtaining samples for microbiological analysis from the lungs of ventilated patients. Furthermore, BAL would form part of the routine investigative work-up for patients suspected of having VAP. In addition, BAL is recommended in severe ALI/ARDS to exclude sepsis prior to the commencement of systemic corticosteroids (Meduri GU, Chinn AJ, Leeper KV et al: Corticosteroid rescue treatment of progressive fibroproliferation in late ARDS: patterns of response and predictors of outcome. Chest 1994, 105:1516-1527). Therefore, informed consent for inclusion into the study, storage of patient data and storage of biological specimens for subsequent analysis will be sought retrospectively from patients after recruitment. Patients will also be asked to provide consent to attend a three month post-Intensive Care Unit (ICU) follow up clinic for assessment of functional outcomes and health status
10. Survivors: Follow-up research clinic at three months at Wellcome Clinical Research Facility (CRF)
a. Health questionnaires
b. Full Pulmonary Function Tests
c. Shuttle walk
d. Bronchoscopy and BAL
11. Further follow-up at 12 months for quantitative density mask analysis of High Resolution Computed Tomography (CT) Thorax if suspected residual pulmonary fibrosis or bronchiectasis from 9., above. This would be my standard clinical management if I saw these patients in Out-Patients Department (OPD) at follow up

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

24/04/2002

Overall trial end date

24/04/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged over 16 years
2. Patient receiving mechanical ventilation
3. Existence of, or risk factors for, ALI/ARDS

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

Not provided at time of registration

Participant exclusion criteria

1. Pregnancy
2. Patient already enrolled in another interventional study
3. Little chance of survival, defined by Simplified Acute Physiologic Score II (SAPS II), over 65 points corresponds to predicted mortality in excess of 77%
4. Contraindication to bronchoscopy at enrolment

Recruitment start date

24/04/2002

Recruitment end date

24/04/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Respiratory Medicine
Birmingham
B15 2TH
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

University Hospital Birmingham NHS Trust (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. 2005 safety and tolerability results in http://www.ncbi.nlm.nih.gov/pubmed/15821216

Publication citations

  1. Safety and tolerability results

    Perkins GD, Chatterjee S, Giles S, McAuley DF, Quinton S, Thickett DR, Gao F, Safety and tolerability of nonbronchoscopic lavage in ARDS., Chest, 2005, 127, 4, 1358-1363, doi: 10.1378/chest.127.4.1358.

Additional files

Editorial Notes