Stránka klinických studií Nct

Clinical Trial Results:
Modulation of lung injury complicating lung resection

Summary
EudraCT number
 2006-004442-16
Trial protocol
 GB  
Global end of trial date
01 Jul 2009

Results information
Results version number
 v1(current)
This version publication date
19 Feb 2020
First version publication date
19 Feb 2020
Other versions

Trial information

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Trial identification
Sponsor protocol code
cro524
Additional study identifiers
ISRCTN number
 -
US NCT number
 NCT00655928
WHO universal trial number (UTN)
 -
Sponsors
Sponsor organisation name
Imperial College London
Sponsor organisation address
South Kensingston Campus, London, United Kingdom, SW7 2AZ
Public contact
Mark J Griffiths, Imperial College London, +44 020 7351 8523, m.griffiths@imperial.ac.uk
Scientific contact
Mark J Griffiths, Imperial College London, +44 020 7351 8523, m.griffiths@imperial.ac.uk
Paediatric regulatory details
Is trial part of an agreed paediatric investigation plan (PIP)
No
Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
No
Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
No
Results analysis stage
Analysis stage
Final
Date of interim/final analysis
01 Jul 2010
Is this the analysis of the primary completion data?
Yes
Primary completion date
01 Jul 2009
Global end of trial reached?
Yes
Global end of trial date
01 Jul 2009
Was the trial ended prematurely?
No
General information about the trial
Main objective of the trial
The aim of this study is to investigate whether it is possible to reduce the amount of lung injury/inflammation caused by one-lung ventilation during lung surgery by giving an antioxidant, acetylcysteine, prior to surgery.
Protection of trial subjects
None
Background therapy
 -
Evidence for comparator
 -
Actual start date of recruitment
01 Aug 2007
Long term follow-up planned
No
Independent data monitoring committee (IDMC) involvement?
No
Population of trial subjects
Number of subjects enrolled per country
Country: Number of subjects enrolled
United Kingdom: 52
Worldwide total number of subjects
52
EEA total number of subjects
52
Number of subjects enrolled per age group
In utero
0
Preterm newborn - gestational age
0
Newborns (0-27 days)
0
Infants and toddlers (28 days-23 months)
0
Children (2-11 years)
0
Adolescents (12-17 years)
0
Adults (18-64 years)
40
From 65 to 84 years
12
85 years and over
0

Subject disposition

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Recruitment
Recruitment details
 Adults undergoing elective lung resection for cancer at the Royal Brompton Hospital, London, UK were eligible. Recruitment was between Aug 2008 and July 2009.

Pre-assignment
Screening details
 90 participants were assessed for eligibility, excluded 38 participants and randomised 52.

Period 1
Period 1 title
Randomization
Is this the baseline period?
 No
Allocation method
Randomised - controlled
Blinding used
 Double blind
Roles blinded
 Subject, Investigator

Arms
Are arms mutually exclusive
Yes

Arm title
 Placebo
Arm description
 Randomization period
Arm type
 No intervention

Investigational medicinal product name
No investigational medicinal product assigned in this arm
Arm title
 N-acetylcysteine (NAC)
Arm description
 Randomization period
Arm type
 No intervention

Investigational medicinal product name
No investigational medicinal product assigned in this arm
Number of subjects in period 1
Placebo N-acetylcysteine (NAC)
Started
26
26
Completed
24
23
Not completed
2
3
     Physician decision
1
2
     Consent withdrawn by subject
1
1
Period 2
Period 2 title
Treatment
Is this the baseline period?
 Yes [1]
Allocation method
Randomised - controlled
Blinding used
 Double blind
Roles blinded
 Subject, Investigator

Arms
Are arms mutually exclusive
Yes

Arm title
 N-acetylcysteine (NAC)
Arm description
 Eligible adults were randomized to receive preoperative infusion of N-acetylcysteine (240 mg/kg over 12 h)
Arm type
 Experimental

Investigational medicinal product name
N-acetylcysteine
Investigational medicinal product code
Other name
Pharmaceutical forms
Concentrate for concentrate for solution for infusion
Routes of administration
Intravenous use
Dosage and administration details
Preoperative infusion of N-acetylcysteine, 240 mg/kg in 1000 mL 0.9% saline over 12 h.

Arm title
 Placebo
Arm description
 Eligible adults were randomized to receive preoperative infusion of placebo.
Arm type
 Placebo

Investigational medicinal product name
Saline
Investigational medicinal product code
Other name
Pharmaceutical forms
Concentrate for concentrate for solution for infusion
Routes of administration
Intravenous use
Dosage and administration details
Preoperative infusion of 1000 mL 0.9% saline over 12 h.

Notes
[1] - Period 1 is not the baseline period. It is expected that period 1 will be the baseline period.
Justification: The group of participants who actually received the allocated treatment.
Number of subjects in period 2 [2]
N-acetylcysteine (NAC) Placebo
Started
23
24
Completed
23
24
Notes
[2] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
Justification: The group of participants who actually received the allocated treatment.

Baseline characteristics

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Baseline characteristics reporting groups
Reporting group title
N-acetylcysteine (NAC)
Reporting group description
 Eligible adults were randomized to receive preoperative infusion of N-acetylcysteine (240 mg/kg over 12 h)

Reporting group title
Placebo
Reporting group description
 Eligible adults were randomized to receive preoperative infusion of placebo.

Reporting group values
 N-acetylcysteine (NAC) Placebo Total
Number of subjects
 23 24 47
Age categorical
Units: Subjects
    In utero
 0
    Preterm newborn infants (gestational age < 37 wks)
 0
    Newborns (0-27 days)
 0
    Infants and toddlers (28 days-23 months)
 0
    Children (2-11 years)
 0
    Adolescents (12-17 years)
 0
    Adults (18-64 years)
 0
    From 65-84 years
 0
    85 years and over
 0
Age continuous
Units: years
    geometric mean (standard deviation)
 68 ± 10.1 63.8 ± 11.5 -
Gender categorical
Units: Subjects
    Female
 8 9 17
    Male
 15 15 30
Spirometry, FEV1
Units: litres
    arithmetic mean (standard deviation)
 2.23 ± 0.97 2.56 ± 0.81 -
Duration of one-lung ventilation
Measure Description: 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.
Units: minutes
    geometric mean (standard deviation)
 134 ± 42 137 ± 59 -

End points

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End points reporting groups
Reporting group title
Placebo
Reporting group description
 Randomization period

Reporting group title
N-acetylcysteine (NAC)
Reporting group description
 Randomization period
Reporting group title
N-acetylcysteine (NAC)
Reporting group description
 Eligible adults were randomized to receive preoperative infusion of N-acetylcysteine (240 mg/kg over 12 h)

Reporting group title
Placebo
Reporting group description
 Eligible adults were randomized to receive preoperative infusion of placebo.

Primary: Post-operative Plasma IL-6

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End point title
 Post-operative Plasma IL-6
End point description
Plasma IL-6 was measured in duplicate using ELISA
End point type
Primary
End point timeframe
Post operative, 24 hours
End point values
 N-acetylcysteine (NAC) Placebo
Number of subjects analysed
23
24
Units: pg/ml
    geometric mean (inter-quartile range (Q1-Q3))
126 (80 to 180)
111 (72 to 162)
Statistical analysis title
 IL 6
Comparison groups
N-acetylcysteine (NAC) v Placebo
Number of subjects included in analysis
47
Analysis specification
Pre-specified
Analysis type
 superiority
P-value
 = 0.09
Method
 t-test, 2-sided
Confidence interval

Adverse events

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Adverse events information
Timeframe for reporting adverse events
6 months
Assessment type
 Non-systematic
Dictionary used for adverse event reporting
Dictionary name
 MedDRA
Dictionary version
10
Reporting groups
Reporting group title
N-acetylcysteine (NAC)
Reporting group description
 Eligible adults were randomized to receive preoperative infusion of N-acetylcysteine (240 mg/kg over 12 h)

Reporting group title
Placebo
Reporting group description
 Eligible adults were randomized to receive preoperative infusion of placebo.

Serious adverse events
 N-acetylcysteine (NAC) Placebo
Total subjects affected by serious adverse events
     subjects affected / exposed
14 / 23 (60.87%)
12 / 24 (50.00%)
     number of deaths (all causes)
0
0
     number of deaths resulting from adverse events
0
0
Injury, poisoning and procedural complications
Acut lung injury
     subjects affected / exposed
1 / 23 (4.35%)
2 / 24 (8.33%)
     occurrences causally related to treatment / all
0 / 1
0 / 2
     deaths causally related to treatment / all
0 / 0
0 / 0
Surgical and medical procedures
Postoperative complication
     subjects affected / exposed
13 / 23 (56.52%)
10 / 24 (41.67%)
     occurrences causally related to treatment / all
0 / 13
0 / 10
     deaths causally related to treatment / all
0 / 0
0 / 0
Frequency threshold for reporting non-serious adverse events: 0%
Non-serious adverse events
 N-acetylcysteine (NAC) Placebo
Total subjects affected by non serious adverse events
     subjects affected / exposed
8 / 23 (34.78%)
5 / 24 (20.83%)
Infections and infestations
Respiratory infection
     subjects affected / exposed
6 / 23 (26.09%)
3 / 24 (12.50%)
     occurrences all number
6
3
Wound infection
     subjects affected / exposed
2 / 23 (8.70%)
0 / 24 (0.00%)
     occurrences all number
2
0
Pleural fluid infection
     subjects affected / exposed
2 / 23 (8.70%)
2 / 24 (8.33%)
     occurrences all number
2
2
Intravascular cannula infection
     subjects affected / exposed
1 / 23 (4.35%)
0 / 24 (0.00%)
     occurrences all number
1
0

More information

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Substantial protocol amendments (globally)
Were there any global substantial amendments to the protocol? No

Interruptions (globally)
Were there any global interruptions to the trial? No

Limitations and caveats
Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
None reported

Online references
http://www.ncbi.nlm.nih.gov/pubmed/26503312

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