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
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Modulation of Lung Injury Complicating Lung Resection

Resource links provided by NLM:


Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • Post-operative plasma IL-6 [ Time Frame: Post operative ] [ Designated as safety issue: No ]

Enrollment: 47
Study Start Date: August 2007
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00655928

Locations
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
Investigators
Principal Investigator: Mark J Griffiths Imperial College London
  More Information

No publications provided

Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT00655928     History of Changes
Other Study ID Numbers: cro524
Study First Received: April 4, 2008
Last Updated: December 22, 2011
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: National Health Service
United Kingdom: Research Ethics Committee

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

Additional relevant MeSH terms:
Lung Injury
Acute Lung Injury
Respiratory Distress Syndrome, Adult
Lung Diseases
Respiratory Tract Diseases
Thoracic Injuries
Wounds and Injuries
Respiration Disorders
Acetylcysteine
N-monoacetylcystine
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes

ClinicalTrials.gov processed this record on September 18, 2014