Modulation of Lung Injury Complicating Lung Resection

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: July 2009

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.

Interventions

  • 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

Arms, Groups and Cohorts

  • Experimental: N-acetylcysteine
    • Participant received N-acetylcysteine 240mg/kg in 1 litre 0.9% saline intravenous over 12 hours pre-operatively
  • Placebo Comparator: Placebo
    • Participant received 0.9% saline 1 litre intravenous over 12 hours pre-operatively

Clinical Trial Outcome Measures

Primary Measures

  • Post-operative Plasma IL-6
    • Time Frame: Post operative, 24 hours
    • Plasma IL-6 was measured in duplicate using ELISA.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Imperial College London
  • Collaborator
    • Royal College of Physicians
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Mark J Griffiths, Principal Investigator, Imperial College London

Citations Reporting on Results

Bastin AJ, Davies N, Lim E, Quinlan GJ, Griffiths MJ. Systemic inflammation and oxidative stress post-lung resection: Effect of pretreatment with N-acetylcysteine. Respirology. 2016 Jan;21(1):180-7. doi: 10.1111/resp.12662. Epub 2015 Oct 27.

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