Modulation of lung injury complicating lung resection

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-004442-16-GB

Enrollment

Unknown

Registered

2009-07-24

Start date

2006-11-29

Completion date

Unknown

Last updated

2017-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute respiratory distress syndrome, Acute Lung Injury, Ventilator-Induced Lung Injury MedDRA version: 8.1 Level: LLT Classification code 10001052 Term: Acute respiratory distress syndrome

Interventions

Trade Name: Parvolex Product Name: Acetylcysteine Pharmaceutical Form: Solution for infusion INN or Proposed INN: Acetylcysteine CAS Number: 000616911 Concentration unit: mg/kg milligram(s)/kilogram C

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Adult patients undergoing elective pulmonary resection (at the Royal Brompton Hospital, the study site) involving the need for one-lung ventilation. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Age < 18 Already taking acetylcysteine Allergy or sensitivity to acetylcysteine Pregnancy or breastfeeding Women of childbearing potential (whether or not taking contraception) Inability to give informed consent for the study (including if this is due to language barrier where no interpreter is available)

Design outcomes

Primary

Measure	Time frame
Main Objective: 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. ;Secondary Objective: Secondary objectives include difference in the concentration of other inflammatory markers in blood and EBC (see table in protocol) following lung resection and one-lung ventilation between the acetylcysteine -treated and placebo groups; difference in clinical markers of lung injury following lung surgery and one-lung ventilation between acetylcysteine -treated and placebo groups.;Primary end point(s): Difference in the change in concentration of an inflammatory marker in plasma (IL-6) following lung surgery and one-lung ventilation between acetylcysteine-treated and placebo groups	—

Measure

Time frame

Main Objective: 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. ;Secondary Objective: Secondary objectives include difference in the concentration of other inflammatory markers in blood and EBC (see table in protocol) following lung resection and one-lung ventilation between the acetylcysteine -treated and placebo groups; difference in clinical markers of lung injury following lung surgery and one-lung ventilation between acetylcysteine -treated and placebo groups.;Primary end point(s): Difference in the change in concentration of an inflammatory marker in plasma (IL-6) following lung surgery and one-lung ventilation between acetylcysteine-treated and placebo groups

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026