Topic: Respiratory, Generic Health Relevance and Cross Cutting Themes
Conditions
Interventions
We shall identify patients with suspected VAP, all of whom will have a lung sample - half of the patients will receive 'usual care' for suspected VAP, the other half will have the new biomarker-based
Sponsors
Newcastle Upon Tyne Hospitals NHS Trust and University of Newcastle Upon Tyne (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 27/11/2013: 1. Age 18 years or over 2. Mechanically ventilated for 48hrs 3. New or worsening changes on chest x-ray or CT scan of the lungs 4. Two or more from: 4.1. Temperature 38ºC 4.2. Blood white cell count 11x10*9/L 4.3. Purulent tracheal secretions 5. The patient is considered suitable for early discontinuation of antibiotics Target Gender: Male & Female ; Lower Age Limit 18 years Previous inclusion criteria: 1. Age 18 years or over 2. Intubated and mechanically ventilated for 48 hrs 3. New or worsening changes on chest x-ray or CT scan of the lungs 4. Two or more from: 4.1. Temperature 38ºC 4.2. Blood white cell count 11x10*9/L 4.3. Purulent tracheal secretions Target Gender: Male & Female ; Lower Age Limit 18 years
Exclusion criteria
Exclusion criteria: 1. PaO2 0.7 2. Positive end-expiratory pressure >15 cmH2O 3. Peak airway pressure >35 cmH2O 4. Heart rate >140 bpm 5. Mean arterial pressure 3) 7. Poorly controlled intracranial pressure (>20 mmHg) 8. ICU consultant deems procedure not to be safe 9. Previous BAL as part of this study 10. Consent declined * Patients who are enrolled in observational studies will be eligible for co-enrolment. Co-enrolment with interventional studies will be possible following consideration of any scientific or statistical interaction, in accordance with current UK Critical Care Research Forum (UKCCRF) recommendations (see appendix). Until coenrolment is considered appropriate for a particular study, patients enrolled in an interventional trial will not be included.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Antibiotic-free days (AFD); Timepoint(s): The frequency distribution of antibiotic-free days (AFD) in the 7 days following BAL | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 27/11/2013: 1. Antibiotic associated infections; Timepoint(s): upto day 56 post-BAL follow up 2. Antibiotic days in the 28 days following BAL; Timepoint(s): number of days on antibiotics compared with both interventions on both randomised groups 3. Antibiotic resistant pathogens; Timepoint(s): collected up to day 56 post-BAL follow up 4. Antibiotics days in 28 days following BAL; Timepoint(s): Comparison of AFD in 28 days between both randomised arms 5. Duration of ICU and hospital stay; Timepoint(s): up to 56 day post-BAL follow up 6. Length of ICU sty and level 3 or level 2 patient; Timepoint(s): up to day 56 post-BAL follow up 7. Mortality; Timepoint(s): 28 day mortality and ICU mortality 8. Sequential organ failure (SOFA) score; Timepoint(s): SOFA score at day 3, day 7, day 14 after enrollment on the study 9. Ventilator Free days; Timepoint(s): Total number of ventilator free days up to day 28 post-BAL follow-up Previous secondary outcome measures: 1. Antibiotic associated infections; Timepoint(s): upto day 56 post-BAL follow up 2. Antibiotic days in the 28 days following BAL; Timepoint(s): number of days on antibiotics compared with both interventions on both randomised groups 3. Antibiotic resistant pathogens; Timepoint(s): collected up to day 56 post-BAL follow up 4. Antibiotics days in 28 days following BAL; Timepoint(s): Comparison of AFD in 28 days between both randomised arms 5. Duration of ICU and hospital stay; Timepoint(s): up to 56 day post-BAL follow up 6. Length of ICU sty and level 3 or level 2 patient; Timepoint(s): up to day 56 post-BAL follow up 7. Mortality; Timepoint(s): 28 day mortality and ICU mortality 8. Sequential | — |
Countries
United Kingdom
Outcome results
None listed