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Modulation of Lung Injury Complicating Lung Resection

Phase 2
Completed
Conditions
Acute Lung Injury
Interventions
Drug: 0.9% saline
Registration Number
NCT00655928
Lead Sponsor
Imperial College London
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.

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
52
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

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Placebo0.9% salineParticipant received 0.9% saline 1 litre intravenous over 12 hours pre-operatively
N-acetylcysteineN-acetylcysteineParticipant received N-acetylcysteine 240mg/kg in 1 litre 0.9% saline intravenous over 12 hours pre-operatively
Primary Outcome Measures
NameTimeMethod
Post-operative Plasma IL-6Post operative, 24 hours

Plasma IL-6 was measured in duplicate using ELISA.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Royal Brompton Hospital

🇬🇧

London, United Kingdom

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