Trial Outcomes & Findings for Modulation of Lung Injury Complicating Lung Resection (NCT NCT00655928)

NCT ID: NCT00655928

Last Updated: 2020-02-05

Results Overview

Plasma IL-6 was measured in duplicate using ELISA.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 52 participants
• Primary outcome timeframe: Post operative, 24 hours
• Results posted on: 2020-02-05

Participant Flow

Participant milestones

Measure	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	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
Overall Study STARTED	26	26
Overall Study COMPLETED	23	24
Overall Study NOT COMPLETED	3	2

Reasons for withdrawal

Measure	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	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
Overall Study Withdrawal by Subject	2	1
Overall Study Physician Decision	1	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	N-acetylcysteine n=23 Participants 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	Placebo n=24 Participants 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	Total n=47 Participants Total of all reporting groups
Age, Continuous	68 years STANDARD_DEVIATION 10.1 • n=23 Participants	63.9 years STANDARD_DEVIATION 11.5 • n=24 Participants	65.95 years STANDARD_DEVIATION 10.8 • n=47 Participants
Sex: Female, Male Female	8 Participants n=23 Participants	9 Participants n=24 Participants	17 Participants n=47 Participants
Sex: Female, Male Male	15 Participants n=23 Participants	15 Participants n=24 Participants	30 Participants n=47 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United Kingdom	23 participants n=23 Participants	24 participants n=24 Participants	47 participants n=47 Participants
Spirometry, FEV1	2.23 litres STANDARD_DEVIATION 0.97 • n=23 Participants	2.56 litres STANDARD_DEVIATION 0.81 • n=24 Participants	2.39 litres STANDARD_DEVIATION 0.89 • n=47 Participants
FVC	3.48 litres STANDARD_DEVIATION 1.17 • n=23 Participants	3.6 litres STANDARD_DEVIATION 1.01 • n=24 Participants	3.54 litres STANDARD_DEVIATION 1.09 • n=47 Participants
Duration of one-lung ventilation	134 minutes STANDARD_DEVIATION 42 • n=23 Participants	137 minutes STANDARD_DEVIATION 59 • n=24 Participants	135.5 minutes STANDARD_DEVIATION 50.5 • n=47 Participants

PRIMARY outcome

Timeframe: Post operative, 24 hours

Plasma IL-6 was measured in duplicate using ELISA.

Outcome measures

Measure	N-acetylcysteine n=23 Participants 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	Placebo n=24 Participants 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
Post-operative Plasma IL-6	126 pg/ml Interval 80.0 to 180.0	111 pg/ml Interval 72.0 to 162.0

Adverse Events

N-acetylcysteine

Serious events: 14 serious events

Other events: 8 other events

Deaths: 0 deaths

Placebo

Serious events: 12 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Measure	N-acetylcysteine n=23 participants at risk 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	Placebo n=24 participants at risk 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
Surgical and medical procedures Postoperative complication	56.5% 13/23 • Number of events 13 • 6 months	41.7% 10/24 • Number of events 10 • 6 months
Injury, poisoning and procedural complications Acut lung injury	4.3% 1/23 • Number of events 1 • 6 months	8.3% 2/24 • Number of events 2 • 6 months

Other adverse events

Measure	N-acetylcysteine n=23 participants at risk 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	Placebo n=24 participants at risk 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
Infections and infestations Respiratory infection	26.1% 6/23 • Number of events 6 • 6 months	12.5% 3/24 • Number of events 3 • 6 months
Infections and infestations Wound infection	8.7% 2/23 • Number of events 2 • 6 months	0.00% 0/24 • 6 months
Infections and infestations Pleural fluid infection	8.7% 2/23 • Number of events 2 • 6 months	8.3% 2/24 • Number of events 2 • 6 months
Infections and infestations Intravascular cannula infection	4.3% 1/23 • Number of events 1 • 6 months	0.00% 0/24 • 6 months

Additional Information

Mark J Griffiths

Imperial College LOndon

Phone: +44 (0) 2073518523

Email: m.griffiths@imperial.ac.uk

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place