Skip to main content
OpenTrials
Completed

NCT Number: NCT00655928

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Acute Lung Injury Lung Diseases Lung Injury Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Royal Brompton Hospital

London, SW3 6NP, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

N-acetylcysteine

Drug

N-acetylcysteine 240mg/kg in 1 litre 0.9% saline intravenous over 12 hours pre-operatively

0.9% saline

Drug

0.9% saline 1 litre intravenous over 12 hours pre-operatively

Other names: placebo

Primary outcomes

  1. Post-operative Plasma IL-6

    Time frame: Post operative, 24 hours

    Plasma IL-6 was measured in duplicate using ELISA.

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Collaborators

  • Royal Brompton & Harefield NHS Foundation Trust
  • Royal College of Physicians

Registry information

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Apr 10, 2008
Registry last updated
Feb 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.