Safety and Efficacy Study of Nitric Oxide in Patients Going Through Lung Transplantation
Condition: Lung Transplantation
Study type: Interventional
Phase: Phase 2

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.
    

Intervention name(s): Nitric oxide; Nitric oxide
Intervention type(s): Drug; Drug
Intervention description(s): inhalation, 10 ppm, for up to 48 hours; inhalation; 10ppm; 3 hours (donor) up to 48 hours (recipient)
Intervention MeSH terms: Nitric Oxide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Lung transplantation