Modulation of Lung Injury Complicating Lung Resection
2 other identifiers
interventional
52
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Aug 2007
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2007
CompletedFirst Submitted
Initial submission to the registry
April 4, 2008
CompletedFirst Posted
Study publicly available on registry
April 10, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2009
CompletedResults Posted
Study results publicly available
September 23, 2019
CompletedFebruary 5, 2020
February 1, 2020
1.9 years
April 4, 2008
August 22, 2019
February 3, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Post-operative Plasma IL-6
Plasma IL-6 was measured in duplicate using ELISA.
Post operative, 24 hours
Study Arms (2)
N-acetylcysteine
EXPERIMENTALParticipant received N-acetylcysteine 240mg/kg in 1 litre 0.9% saline intravenous over 12 hours pre-operatively
Placebo
PLACEBO COMPARATORParticipant received 0.9% saline 1 litre intravenous over 12 hours pre-operatively
Interventions
N-acetylcysteine 240mg/kg in 1 litre 0.9% saline intravenous over 12 hours pre-operatively
0.9% saline 1 litre intravenous over 12 hours pre-operatively
Eligibility Criteria
You may qualify if:
- Elective lung resection for cancer
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Imperial College Londonlead
- Royal College of Physicianscollaborator
- Royal Brompton & Harefield NHS Foundation Trustcollaborator
Study Sites (1)
Royal Brompton Hospital
London, SW3 6NP, United Kingdom
Related Publications (1)
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.
PMID: 26503312RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
The investigator did not sample the pulmonary compartment for markers of inflammation or oxidative damage due to reliance on OLV during surgery, may have led to underestimation of pulmonary inflammation and effect of antioxidant supplementation.
Results Point of Contact
- Title
- Mark J Griffiths
- Organization
- Imperial College LOndon
Study Officials
- PRINCIPAL INVESTIGATOR
Mark J Griffiths
Imperial College London
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 4, 2008
First Posted
April 10, 2008
Study Start
August 1, 2007
Primary Completion
July 1, 2009
Study Completion
July 1, 2009
Last Updated
February 5, 2020
Results First Posted
September 23, 2019
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will not share