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Modulation of Lung Injury Complicating Lung Resection

Primary Purpose

Acute Lung Injury

Status
Completed
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
N-acetylcysteine
0.9% saline
Sponsored by
Imperial College London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute Lung Injury focused on measuring Acute lung injury, Lung resection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Royal Brompton Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

N-acetylcysteine

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Post-operative Plasma IL-6
Plasma IL-6 was measured in duplicate using ELISA.

Secondary Outcome Measures

Full Information

First Posted
April 4, 2008
Last Updated
February 3, 2020
Sponsor
Imperial College London
Collaborators
Royal College of Physicians, Royal Brompton & Harefield NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT00655928
Brief Title
Modulation of Lung Injury Complicating Lung Resection
Official Title
Modulation of Lung Injury Complicating Lung Resection
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Imperial College London
Collaborators
Royal College of Physicians, Royal Brompton & Harefield NHS Foundation Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Lung Injury
Keywords
Acute lung injury, Lung resection

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
N-acetylcysteine
Arm Type
Experimental
Arm Description
Participant received N-acetylcysteine 240mg/kg in 1 litre 0.9% saline intravenous over 12 hours pre-operatively
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participant received 0.9% saline 1 litre intravenous over 12 hours pre-operatively
Intervention Type
Drug
Intervention Name(s)
N-acetylcysteine
Intervention Description
N-acetylcysteine 240mg/kg in 1 litre 0.9% saline intravenous over 12 hours pre-operatively
Intervention Type
Drug
Intervention Name(s)
0.9% saline
Other Intervention Name(s)
placebo
Intervention Description
0.9% saline 1 litre intravenous over 12 hours pre-operatively
Primary Outcome Measure Information:
Title
Post-operative Plasma IL-6
Description
Plasma IL-6 was measured in duplicate using ELISA.
Time Frame
Post operative, 24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark J Griffiths
Organizational Affiliation
Imperial College London
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Brompton Hospital
City
London
ZIP/Postal Code
SW3 6NP
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26503312
Citation
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.
Results Reference
result

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Modulation of Lung Injury Complicating Lung Resection

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