Modulation of Lung Injury Complicating Lung Resection

Imperial College London

Status and phase: Completed; Phase 2

Conditions: Acute Lung Injury

Treatments: Drug: N-acetylcysteine; Drug: 0.9% saline

Study type: Interventional

Funder types: Other

Identifiers

NCT00655928

cro524

2006-004442-16 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 52 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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52 participants in 2 patient groups, including a placebo group

N-acetylcysteine

Experimental group

Description:

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

Treatment:

Drug: N-acetylcysteine

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: 0.9% saline