A Phase 2 interventional study of N-acetylcysteine and 0.9% saline in Acute Lung Injury, sponsored by Imperial College London. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-02-05.
Sponsored by Imperial College London · Phase 2, Interventional, and Prevention
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.
399 studies on the registry are indexed under Lung Injury; 50 are open to participants now.
This study's enrollment of 52 is close to the median of 53 across 239 interventional studies indexed under Lung Injury.
Browse Lung Injury studies →Imperial College London is the lead sponsor of 824 studies on the registry; 178 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participant received N-acetylcysteine 240mg/kg in 1 litre 0.9% saline intravenous over 12 hours pre-operatively
Drug: N-acetylcysteine
Participant received 0.9% saline 1 litre intravenous over 12 hours pre-operatively
Drug: 0.9% saline
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
Also known as: placebo
Post-operative Plasma IL-6
Plasma IL-6 was measured in duplicate using ELISA.
Time frame: Post operative, 24 hours
| Milestone | N-acetylcysteine | Placebo |
|---|---|---|
| Started | 26 | 26 |
| Completed | 23 | 24 |
| Not completed | 3 | 2 |
| Withdrew: Withdrawal by subject | 2 | 1 |
| Withdrew: Physician decision | 1 | 1 |
Plasma IL-6 was measured in duplicate using ELISA.
| pg/ml | N-acetylcysteine | Placebo |
|---|---|---|
| Post-operative Plasma IL-6 | 126 (80 to 180) | 111 (72 to 162) |
Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| N-acetylcysteine | 0/23 (0%) | 14/23 (60.9%) | 8/23 (34.8%) |
| Placebo | 0/24 (0%) | 12/24 (50%) | 5/24 (20.8%) |
| Event | N-acetylcysteine | Placebo |
|---|---|---|
| Postoperative complicationSurgical and medical procedures | 13/23 | 10/24 |
| Acut lung injuryInjury, poisoning and procedural complications | 1/23 | 2/24 |
| Event | N-acetylcysteine | Placebo |
|---|---|---|
| Respiratory infectionInfections and infestations | 6/23 | 3/24 |
| Wound infectionInfections and infestations | 2/23 | 0/24 |
| Pleural fluid infectionInfections and infestations | 2/23 | 2/24 |
| Intravascular cannula infectionInfections and infestations | 1/23 | 0/24 |
| Age, Continuous(years) | N-acetylcysteine | Placebo | Total |
|---|---|---|---|
| Mean | 68 ± 10.1 | 63.9 ± 11.5 | 65.95 ± 10.8 |
| Sex: Female, Male(Participants) | N-acetylcysteine | Placebo | Total |
|---|---|---|---|
| Female | 8 | 9 | 17 |
| Male | 15 | 15 | 30 |
| Race and Ethnicity Not Collected(Participants) | N-acetylcysteine | Placebo | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | N-acetylcysteine | Placebo | Total |
|---|---|---|---|
| United Kingdom | 23 | 24 | 47 |
| Spirometry, FEV1(litres) | N-acetylcysteine | Placebo | Total |
|---|---|---|---|
| Mean | 2.23 ± 0.97 | 2.56 ± 0.81 | 2.39 ± 0.89 |
| FVC(litres) | N-acetylcysteine | Placebo | Total |
|---|---|---|---|
| Mean | 3.48 ± 1.17 | 3.6 ± 1.01 | 3.54 ± 1.09 |
| Duration of one-lung ventilation(minutes) | N-acetylcysteine | Placebo | Total |
|---|---|---|---|
| Mean | 134 ± 42 | 137 ± 59 | 135.5 ± 50.5 |
Plan to share: No
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Imperial College London