NCT00570245

Safety and Efficacy Study of Nitric Oxide in Patients Going Through Lung Transplantation

A Pilot, Single Center Prospective, With Parallel Groups, Controlled and Open to Evaluate the Efficacy of Nitric Oxide for Inhalation in Lung Donors and in the Prevention of Reperfusion Injury.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Mallinckrodt · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the safety and efficacy of inhaled nitric oxide in prevention of lung graft dysfunction due to ischemia-reperfusion

Detailed description

* Pilot, single-center, prospective, randomized, parallel-group, controlled, open-label trial. * Sixty lung donors will be analyzed, making a comparative study between donors receiving NO for 3 hours prior to removal of the organ versus a control group to which NO will not be administered. * A Swan-Ganz catheter will be placed to determine PVR, PAP, MV, and PCP; and blood gases will be done after arterial cannulation to determine FiO2/PaO2 hourly. Also, standard blood chemistry, hematology, coagulation parameters, and arterial blood gas. * Prior to NO administration and before procurement, a BAL (bronchoalveolar lavage) will be done to determine the presence of leukocytes, predominantly neutrophils, IL-1, IL-6, IL-8, IL-10, TNF, and proteins as well as obtaining secretions for culture. * The dosage of NO will be 10ppm, with NO2 and methemoglobinemia being monitored exhaustively. * In the operating room and prior to lung removal, a new BAL will be done and the anti-inflammatory agents described above will be determined. * Organ removal and the preservation fluid used will be standard, according to the established surgical protocol. * Anesthesia: methylprednisolone 1 g will be administered before organ extraction; hemodynamic determinations of mAP, PAP, CVP, MV, and hourly urinary output and arterial blood gas. * Hemodynamic and respiratory determinations will be made in the lung receptors: mAP, mPAP, PVR, MV, PCP, DO2, Qs/Qt, and CVP as well as gas determinations every 30 minutes, blood chemistry, hematology, and coagulation immediately after reperfusion. A BAL will also be done after anesthesia induction. * Incidents during surgery will be recorded, especially the need for extracorporeal circulation as well as transfusion requirements and ischemia times. * After surgery, another BAL will be done both 24 hours and 48 hours after return to the Recovery Unit. Hemodynamic and respiratory parameters will be monitored every 4 hours for the first 48 hours after surgery, as well as arterial blood gases. * Blood chemistry will be done every 12 hours along with coagulation and hematology tests. * Chest x-ray on admission and daily to determine the degree of the patient's edema over the first 48 hours. * Drug administration: the NO will be administered in the respirator intake at a dose of 10ppm for 48 hours. A monitor will be used showing the gas dosage continuously, as well as NO2 and methemoglobinemia. * The inflammatory agents (TNF, IL-1, IL-2, IL-6, IL-8, and IL-10) will be determined with the ELISA technique.

Conditions

• Lung Transplantation

Interventions

Type	Name	Description
DRUG	Nitric oxide	inhalation, 10 ppm, for up to 48 hours
DRUG	Nitric oxide	inhalation; 10ppm; 3 hours (donor) up to 48 hours (recipient)

Timeline

• Start date: 2005-04-01
• Primary completion: 2008-06-01
• Completion: 2008-06-01
• First posted: 2007-12-10
• Last updated: 2016-10-19

Locations

1 site across 1 country: Spain