Routine quantitative microbiological screening in ventilated patients with, or at risk of, ALI/ARDS: effects on survival and long-term morbidity
| ISRCTN | ISRCTN84441248 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN84441248 |
| Secondary identifying numbers | N0265109355 |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 08/02/2012
- 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
Dr D Thickett
Scientific
Scientific
Respiratory Medicine
Queen Elizabeth Hospital
Birmingham
B15 2TH
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Screening |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 24/04/2002 |
| Completion date | 24/04/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target number of participants | Not provided at time of registration |
| Key inclusion criteria | 1. Aged over 16 years 2. Patient receiving mechanical ventilation 3. Existence of, or risk factors for, ALI/ARDS |
| Key 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 |
| Date of first enrolment | 24/04/2002 |
| Date of final enrolment | 24/04/2008 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Respiratory Medicine
Birmingham
B15 2TH
United Kingdom
B15 2TH
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.doh.gov.uk |
|---|
Funders
Funder type
Government
University Hospital Birmingham NHS Trust (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? |
|---|---|---|---|---|---|
| Results article | safety and tolerability results | 01/04/2005 | Yes | No |
