A pilot, unicenter, prospective, aleatorized, with parallel groups, controlled and open to evaluate the efficacy of the Nitric Oxide for Inhalation in the prevention of reperfusion in pulmonary donor
Phase 1
- Conditions
- pulmonary graft dysfunction
- Registration Number
- EUCTR2004-004928-12-ES
- Lead Sponsor
- INO Therapeutics AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 0
Inclusion Criteria
1. To have scheduled a pulmonary graft
2. Males or females, ages 18 years to 65 years, inclusive
3. Signed IRB/IEC 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)
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
1.BacterianInfection
2.Creatinina< 50 ml/min
3.Extrapulmonary severe organic dysfunction
4.To smoke
5.Neoplasia
6.To be pregant
7.Osteoporosis
8.Úlcus pepticus
9.Progresive neuromuscular siknecks
10.Sistemyc sickness. Complicated Diabetes
11.Any contradition that the investigator considers the exclusion
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary end point(s): pulmonary graft dysfunction presence or not;Main Objective: The main objective is to confirm the oxide nitric efficacy in the prevention of Pulmonary graft malfunction due to the isquemia-reperfusion damage because of pulmonary vasodilated and anti-inflamatory characteristics;Secondary Objective: 1.To compare the Hemodinamic results between the group with oxide nitric administration and the group with no administration.<br>2.To study the NO effects in the reduction of the pulmonary hypertension and the pulmonary vascular resistance <br>3.To analyze the anti-inflammatory effects of the NO, Neutrophil adhesion and citoquines production.<br>
- Secondary Outcome Measures
Name Time Method