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Modulation of Lung Injury Complicating Lung Resection

This study has been completed.
Sponsor:
Collaborators:
Royal College of Physicians
Royal Brompton & Harefield NHS Foundation Trust
Information provided by (Responsible Party):
Imperial College London
ClinicalTrials.gov Identifier:
NCT00655928
First received: April 4, 2008
Last updated: December 22, 2011
Last verified: December 2011
History of Changes

April 4, 2008
December 22, 2011
August 2007
July 2009   (final data collection date for primary outcome measure)
Post-operative plasma IL-6 [ Time Frame: Post operative ] [ Designated as safety issue: No ]
Leukotriene B4 level in exhaled breath condensate [ Time Frame: Post operative ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00655928 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Modulation of Lung Injury Complicating Lung Resection
Modulation of Lung Injury Complicating Lung Resection

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.

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.
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Acute Lung Injury
  • Drug: N-acetylcysteine
    N-acetylcysteine 240mg/kg in 1 litre 0.9% saline intravenous over 12 hours pre-operatively
  • Drug: 0.9% saline
    0.9% saline 1 litre intravenous over 12 hours pre-operatively
  • Experimental: 1
    Intervention: Drug: N-acetylcysteine
  • Placebo Comparator: 2
    Intervention: Drug: 0.9% saline
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
47
July 2009
July 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Elective lung resection for cancer

Exclusion Criteria:

  • Age less than 18 years
  • Women of child-bearing age or potential
  • Known allergy to N-acetylcysteine
  • Oral steroid in the preceding 1 month
  • N-acetylcysteine in the preceding 1 month
  • Unable to receive standardised anaesthetic approach
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00655928
cro524
No
Imperial College London
Imperial College London
  • Royal College of Physicians
  • Royal Brompton & Harefield NHS Foundation Trust
Principal Investigator: Mark J Griffiths Imperial College London
Imperial College London
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP