Safety and Efficacy Study of Nitric Oxide in Patients Going Through Lung Transplantation
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|ClinicalTrials.gov Identifier: NCT00570245|
Recruitment Status : Completed
First Posted : December 10, 2007
Last Update Posted : October 19, 2016
|Condition or disease||Intervention/treatment||Phase|
|Lung Transplantation||Drug: Nitric oxide||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||49 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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.|
|Study Start Date :||April 2005|
|Actual Primary Completion Date :||June 2008|
|Actual Study Completion Date :||June 2008|
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)
- Edema and mPAP [ Time Frame: 4 - 48 hours ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00570245
|Hospital General La Fe|
|Valencia, Spain, 46009|
|Principal Investigator:||Rosario Vicente, MD||Hospital General La Fe|