INFLUENCE OF THE ANTIOXIDANT N-ACETYLCYSTEINE ON INHALED NITRIC OXIDE INDUCED PULMONARY RESPONSES FOLLOWING HUMAN LUNG ISCHAEMIA-REPERFUSION INJURY

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-001525-28-GB

Enrollment

Registered

2006-02-14

Start date

2006-03-24

Completion date

Unknown

Last updated

2020-10-13

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

Conditions

heart-lung transplantation

Interventions

Product Name: INOmax® (nitric oxide) Pharmaceutical Form: Inhalation gas INN or Proposed INN: nitric oxide Concentration unit: % percent Concentration type: equal Concentration number: 0.08- Product

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: The expected study population will include patients undergoing lung, heart-lung and heart transplantation who meet the following inclusion criteria 1. The patients exhibit a moderate degree of impaired gas exchange (PaO2/FiO2 ratios within the range of 150-300 mmHg) or pulmonary hypertension (mean PAP > 25 mmHg) and increased pulmonary vascular resistance (PVR > 250 dynes x sec/cm-5) in the postoperative period 2. Greater than 18 years of age 3. signed IRB approved informed consent 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) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Severe lung injury with PaO2/FiO2 ratios < 150 mmHg in patients who are potential candidates for rescue therapy with iNO on clinical grounds 2. Received intravenous nitrate therapy or other investigational drug within the 24 hours preceding surgery 3. Pregnancy 4. Patients with asthma. This group will be excluded in view of potential bronchospasm as an adverse effect of N-acetylcysteine

Design outcomes

Primary

Measure	Time frame
Secondary Objective: The secondary study objective is to explore at a biochemical level the potential interaction of N-acetylcysteine and inhaled NO in reducing intrapulmonary oxidative stress and augmenting the NO-soluble guanylate cyclase-cGMP pathway. ;Main Objective: The primary objective of the trial is to assess the influence of increasing concentrations of inhaled NO on pulmonary gas exchange and pulmonary arterial pressures and vascular resistance prior to and following administration of the antioxidant N-acetylcysteine in a cardiothoracic transplant population exhibiting a moderate degree of lung injury.;Primary end point(s): 1. Index of oxygenation (PaO2/FiO2 ratio) 2. Pulmonary and systemic hemodynamics (pulmonary artery pressure: PAP, central venous pressure: CVP, pulmonary artery occlusion pressure: PAOP, pulmonary vascular resistance: PVR, pulmonary vascular resistance index: PVRI, mean arterial pressure: MAP, cardiac output: CO, cardiac index: CI, systemic vascular resistance: SVR, systemic vascular resistance index: SVRI, right ventricular ejection fraction RVEF)	—

Measure

Time frame

Secondary Objective: The secondary study objective is to explore at a biochemical level the potential interaction of N-acetylcysteine and inhaled NO in reducing intrapulmonary oxidative stress and augmenting the NO-soluble guanylate cyclase-cGMP pathway. ;Main Objective: The primary objective of the trial is to assess the influence of increasing concentrations of inhaled NO on pulmonary gas exchange and pulmonary arterial pressures and vascular resistance prior to and following administration of the antioxidant N-acetylcysteine in a cardiothoracic transplant population exhibiting a moderate degree of lung injury.;Primary end point(s): 1. Index of oxygenation (PaO2/FiO2 ratio) 2. Pulmonary and systemic hemodynamics (pulmonary artery pressure: PAP, central venous pressure: CVP, pulmonary artery occlusion pressure: PAOP, pulmonary vascular resistance: PVR, pulmonary vascular resistance index: PVRI, mean arterial pressure: MAP, cardiac output: CO, cardiac index: CI, systemic vascular resistance: SVR, systemic vascular resistance index: SVRI, right ventricular ejection fraction RVEF)

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Countries

United Kingdom

Outcome results

None listed

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