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

Phase 1

• Conditions: heart-lung transplantation

• Registration Number: EUCTR2005-001525-28-GB
• Lead Sponsor: Imperial College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-02-14
• Study Completion: 2007-01-01
• Last Update Posted: 13 October 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 43

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified