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| Sponsors and Collaborators: |
Imperial College London Royal College of Physicians Royal Brompton Hospital NHS Trust |
| Information provided by: | Imperial College London |
| ClinicalTrials.gov Identifier: | NCT00655928 |
Purpose
The purpose of this study is to determine whether N-acetylcysteine given intravenously 1 day pre-operatively is effective in preventing inflammation in the lungs, as measured by tests on blood, breath and lung specimens, in patients undergoing surgery to remove a portion of lung.
| Condition | Intervention | Phase |
|
Acute Lung Injury |
Drug: N-acetylcysteine Drug: 0.9% saline |
Phase II |
| ChemIDplus related topics: | Sodium chloride Acetylcysteine |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study |
| Official Title: | Modulation of Lung Injury Complicating Lung Resection |
| Estimated Enrollment: | 108 |
| Study Start Date: | August 2007 |
| Estimated Study Completion Date: | July 2009 |
| Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
| 1: Experimental |
Drug: N-acetylcysteine
N-acetylcysteine 240mg/kg in 1 litre 0.9% saline intravenous over 12 hours pre-operatively
|
| 2: Placebo Comparator |
Drug: 0.9% saline
0.9% saline 1 litre intravenous over 12 hours pre-operatively
|
Acute lung injury occurs following lung resection in about 5% cases, and has a high mortality of around 50%. Management of these patients is largely supportive. Even in patients who do not develop clinical evidence of acute lung injury, markers of inflammation and oxidative stress are present in blood and exhaled breath condensate after lung resection. The purpose of this randomised double-blind placebo-controlled study is to determine whether lung injury can be prevented by pre-administration of N-acetylcysteine.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Mark J Griffiths | +44 (0)20 7351 8523 | m.griffiths@imperial.ac.uk |
| Contact: Anthony J Bastin | +44 (0)20 7351 8523 | a.bastin@imperial.ac.uk |
| United Kingdom | |||||
| Royal Brompton Hospital | Recruiting | ||||
| London, United Kingdom, SW3 6NP | |||||
| Contact: Mark J Griffiths +44 (0)20 7351 8523 m.griffiths@imperial.ac.uk | |||||
| Contact: Anthony J Bastin +44 (0)20 7351 8523 a.bastin@imperial.ac.uk | |||||
| Principal Investigator: Mark J Griffiths | |||||
| Sub-Investigator: Anthony J Bastin | |||||
| Imperial College London |
| Royal College of Physicians |
| Royal Brompton Hospital NHS Trust |
| Principal Investigator: | Mark J Griffiths | Imperial College London |
More Information
| Responsible Party: | Imperial College London ( Dr Mark Griffiths ) |
| Study ID Numbers: | cro524 |
| First Received: | April 4, 2008 |
| Last Updated: | April 4, 2008 |
| ClinicalTrials.gov Identifier: | NCT00655928 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency; United Kingdom: National Health Service; United Kingdom: Research Ethics Committee |
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