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Phase 2 N=52 Randomized Quadruple-blind Prevention

Modulation of Lung Injury Complicating Lung Resection

Acute Lung Injury

Enrolled (actual)
52
Serious AEs
55.3%
Results posted
Sep 2019
Primary outcome: Primary: Post-operative Plasma IL-6 — 126; 111 pg/ml — p=0.09

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
N-acetylcysteine (Drug); 0.9% saline (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Imperial College London
Primary completion
Jul 2009

Outcome Measures

OutcomeResultp-value
PRIMARY
Post-operative Plasma IL-6
126; 111 0.09

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.

Eligibility 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00655928). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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