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Modulation of Lung Injury Complicating Lung Resection

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ClinicalTrials.gov Identifier: NCT00655928
Recruitment Status : Completed
First Posted : April 10, 2008
Last Update Posted : December 23, 2011
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Acute Lung Injury Drug: N-acetylcysteine Drug: 0.9% saline Phase 2

Detailed Description:
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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Modulation of Lung Injury Complicating Lung Resection
Study Start Date : August 2007
Primary Completion Date : July 2009
Study Completion Date : July 2009

Arms and Interventions

Arm Intervention/treatment
Experimental: 1 Drug: N-acetylcysteine
N-acetylcysteine 240mg/kg in 1 litre 0.9% saline intravenous over 12 hours pre-operatively
Placebo Comparator: 2 Drug: 0.9% saline
0.9% saline 1 litre intravenous over 12 hours pre-operatively

Outcome Measures

Primary Outcome Measures :
  1. Post-operative plasma IL-6 [ Time Frame: Post operative ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00655928

United Kingdom
Royal Brompton Hospital
London, United Kingdom, SW3 6NP
Sponsors and Collaborators
Imperial College London
Royal College of Physicians
Royal Brompton & Harefield NHS Foundation Trust
Principal Investigator: Mark J Griffiths Imperial College London
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT00655928     History of Changes
Other Study ID Numbers: cro524
First Posted: April 10, 2008    Key Record Dates
Last Update Posted: December 23, 2011
Last Verified: December 2011

Keywords provided by Imperial College London:
Acute lung injury
Lung resection

Additional relevant MeSH terms:
Wounds and Injuries
Lung Injury
Acute Lung Injury
Respiratory Distress Syndrome, Adult
Lung Diseases
Respiratory Tract Diseases
Thoracic Injuries
Respiration Disorders
Antiviral Agents
Anti-Infective Agents
Respiratory System Agents
Free Radical Scavengers
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs