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NCT00655928 Clinical Trial

Modulation of Lung Injury Complicating Lung Resection

Acute Lung Injury Clinical Trial

Official title:
Modulation of Lung Injury Complicating Lung Resection

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00655928
Other study ID # cro524
Secondary ID 2006-004442-16
Status Completed
Phase Phase 2
First received
Last updated
Start date August 2007
Est. completion date July 2009

Study information
Verified date February 2020
Source Imperial College London
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 52
Est. completion date July 2009
Est. primary completion date July 2009
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United Kingdom Royal Brompton Hospital London

Sponsors (3)
Lead Sponsor Collaborator
Imperial College London Royal Brompton & Harefield NHS Foundation Trust, Royal College of Physicians

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Post-operative Plasma IL-6 Plasma IL-6 was measured in duplicate using ELISA. Post operative, 24 hours
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