safety and efficacy study of nitric oxide in patients going through lung transplantation

Conditions: Lung Transplantation

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

* 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.

Eligibility criteria:
inclusion criteria: * have a lung graft scheduled * males and females aged 18 to 65 * signed informed consent approved by the irb/ec exclusion criteria: * uncontrolled bacterial infection * creatinine clearance \<50 ml/min * severe extrapulmonary organic dysfunction * continuing smoking habit * neoplastic disease (2-5 years free of tumor, depending on type) * pregnancy or nursing * severe osteoporosis * active peptic ulcer * progressive neuromuscular disease * active limiting systemic disease. complicated diabetes. * any contraindication based on the judgement of the investigator

Keywords: lung transplantation