Safety and Efficacy Study of Nitric Oxide in Patients Going Through Lung Transplantation
This study has been completed.
Information provided by:
First received: December 6, 2007
Last updated: January 23, 2013
Last verified: January 2013
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
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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.|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by INO Therapeutics:
Primary Outcome Measures:
- Edema and mPAP [ Time Frame: 4 - 48 hours ] [ Designated as safety issue: Yes ]
|Study Start Date:||April 2005|
|Study Completion Date:||June 2008|
|Primary Completion Date:||June 2008 (Final data collection date for primary outcome measure)|
No Intervention: A
Neither donors or recipients will receive NO
Active Comparator: B
Donor will not receive NO, recipient will receive up to 48 hours of NO
Drug: Nitric oxide
inhalation, 10 ppm, for up to 48 hours
Active Comparator: C
The donor will receive NO for 3 hours and the recipient will receive NO for up to 48 hours
Drug: Nitric oxide
inhalation; 10ppm; 3 hours (donor) up to 48 hours (recipient)
- 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.
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