Modulation of lung injury complicating lung resectio
Phase 1
- Conditions
- Acute respiratory distress syndrome, Acute Lung Injury, Ventilator-Induced Lung InjuryMedDRA version: 8.1Level: LLTClassification code 10001052Term: Acute respiratory distress syndrome
- Registration Number
- EUCTR2006-004442-16-GB
- Lead Sponsor
- Imperial College London
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Adult patients undergoing elective pulmonary resection (at the Royal Brompton Hospital, the study site) involving the need for one-lung ventilation.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Age < 18
Already taking acetylcysteine
Allergy or sensitivity to acetylcysteine
Pregnancy or breastfeeding
Women of childbearing potential (whether or not taking contraception)
Inability to give informed consent for the study (including if this is due to language barrier where no interpreter is available)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The aim of this study is to investigate whether it is possible to reduce the amount of lung injury/inflammation caused by one-lung ventilation during lung surgery by giving an antioxidant, acetylcysteine, prior to surgery. ;Secondary Objective: Secondary objectives include difference in the concentration of other inflammatory markers in blood and EBC (see table in protocol) following lung resection and one-lung ventilation between the acetylcysteine -treated and placebo groups; difference in clinical markers of lung injury following lung surgery and one-lung ventilation between acetylcysteine -treated and placebo groups.;Primary end point(s): Difference in the change in concentration of an inflammatory marker in plasma (IL-6) following lung surgery and one-lung ventilation between acetylcysteine-treated and placebo groups
- Secondary Outcome Measures
Name Time Method