Modulation of Lung Injury Complicating Lung Resection

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2009-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Acute Lung Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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N-acetylcysteine

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

Group Type EXPERIMENTAL

N-acetylcysteine

Intervention Type DRUG

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

Placebo

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

Group Type PLACEBO_COMPARATOR

0.9% saline

Intervention Type DRUG

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

Interventions

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N-acetylcysteine

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

Intervention Type DRUG

0.9% saline

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

Intervention Type DRUG

Other Intervention Names

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placebo

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No