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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
1. 2005 safety and tolerability results in http://www.ncbi.nlm.nih.gov/pubmed/15821216
Publication citations
-
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.