Safety and Efficacy Study of Nitric Oxide in Patients Going Through Lung Transplantation
- Registration Number
- NCT00570245
- Lead Sponsor
- Mallinckrodt
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 49
- Have a lung graft scheduled
- Males and females aged 18 to 65
- Signed informed consent approved by the IRB/EC
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description C Nitric oxide The donor will receive NO for 3 hours and the recipient will receive NO for up to 48 hours B Nitric oxide Donor will not receive NO, recipient will receive up to 48 hours of NO
- Primary Outcome Measures
Name Time Method Edema and mPAP 4 - 48 hours
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Hospital General La Fe
🇪🇸Valencia, Spain