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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-004928-12-ES

Enrollment

Registered

2005-11-04

Start date

2005-03-03

Completion date

Unknown

Last updated

2022-04-19

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

Conditions

pulmonary graft dysfunction

Interventions

Trade Name: INOmax Product Name: INOmax Pharmaceutical Form: Endotracheopulmonary instillation* Concentration type: equal Concentration number: 400-ppm

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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. 2. To study the NO effects in the reduction of the pulmonary hypertension and the pulmonary vascular resistance 3. To analyze the anti-inflammatory effects of the NO, Neutrophil adhesion and citoquines production.	—

Measure

Time frame

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. 2. To study the NO effects in the reduction of the pulmonary hypertension and the pulmonary vascular resistance 3. To analyze the anti-inflammatory effects of the NO, Neutrophil adhesion and citoquines production.

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Countries

Spain

Outcome results

None listed

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