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| ID | Type | Description | Link |
|---|---|---|---|
| 2006-004442-16 | EudraCT Number |
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| Name | Class |
|---|---|
| Royal College of Physicians | OTHER |
| Royal Brompton & Harefield NHS Foundation Trust | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| N-acetylcysteine | Experimental | Participant received N-acetylcysteine 240mg/kg in 1 litre 0.9% saline intravenous over 12 hours pre-operatively |
|
| Placebo | Placebo Comparator | Participant received 0.9% saline 1 litre intravenous over 12 hours pre-operatively |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| N-acetylcysteine | Drug | N-acetylcysteine 240mg/kg in 1 litre 0.9% saline intravenous over 12 hours pre-operatively |
|
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative Plasma IL-6 | Plasma IL-6 was measured in duplicate using ELISA. | Post operative, 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark J Griffiths | Imperial College London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Brompton Hospital | London | SW3 6NP | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26503312 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | N-acetylcysteine | Participant received N-acetylcysteine 240mg/kg in 1 litre 0.9% saline intravenous over 12 hours pre-operatively N-acetylcysteine: N-acetylcysteine 240mg/kg in 1 litre 0.9% saline intravenous over 12 hours pre-operatively |
| FG001 | Placebo | Participant received 0.9% saline 1 litre intravenous over 12 hours pre-operatively 0.9% saline: 0.9% saline 1 litre intravenous over 12 hours pre-operatively |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | N-acetylcysteine | Participant received N-acetylcysteine 240mg/kg in 1 litre 0.9% saline intravenous over 12 hours pre-operatively N-acetylcysteine: N-acetylcysteine 240mg/kg in 1 litre 0.9% saline intravenous over 12 hours pre-operatively |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Post-operative Plasma IL-6 | Plasma IL-6 was measured in duplicate using ELISA. | Posted | Mean | Inter-Quartile Range | pg/ml | Post operative, 24 hours |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | N-acetylcysteine | Participant received N-acetylcysteine 240mg/kg in 1 litre 0.9% saline intravenous over 12 hours pre-operatively N-acetylcysteine: N-acetylcysteine 240mg/kg in 1 litre 0.9% saline intravenous over 12 hours pre-operatively |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Postoperative complication | Surgical and medical procedures | MedDRA (10.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Respiratory infection | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mark J Griffiths | Imperial College LOndon | +44 (0) 2073518523 | m.griffiths@imperial.ac.uk |
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| ID | Term |
|---|---|
| D055371 | Acute Lung Injury |
| ID | Term |
|---|---|
| D055370 | Lung Injury |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000111 | Acetylcysteine |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D003545 | Cysteine |
| D000603 | Amino Acids, Sulfur |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| 0.9% saline | Drug | 0.9% saline 1 litre intravenous over 12 hours pre-operatively |
|
|
Participant received 0.9% saline 1 litre intravenous over 12 hours pre-operatively 0.9% saline: 0.9% saline 1 litre intravenous over 12 hours pre-operatively |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Spirometry, FEV1 | Mean | Standard Deviation | litres |
|
| FVC | Mean | Standard Deviation | litres |
|
| Duration of one-lung ventilation | One lung ventilation is a process that refers to mechanical separation of the two lungs to allow ventilation of only one lung, while the other lung is compressed by the surgeon or allowed to passively deflate. | Mean | Standard Deviation | minutes |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| 0 |
| 23 |
| 14 |
| 23 |
| 8 |
| 23 |
| EG001 | Placebo | Participant received 0.9% saline 1 litre intravenous over 12 hours pre-operatively 0.9% saline: 0.9% saline 1 litre intravenous over 12 hours pre-operatively | 0 | 24 | 12 | 24 | 5 | 24 |
| Acut lung injury | Injury, poisoning and procedural complications | med | Non-systematic Assessment |
|
| Wound infection | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
|
| Pleural fluid infection | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
|
| Intravascular cannula infection | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
|
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| D000596 |
| Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |