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Safety and Efficacy Study of Nitric Oxide in Patients Going Through Lung Transplantation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00570245
Recruitment Status : Completed
First Posted : December 10, 2007
Last Update Posted : October 19, 2016
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Lung Transplantation Drug: Nitric oxide Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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.
Study Start Date : April 2005
Actual Primary Completion Date : June 2008
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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)

Primary Outcome Measures :
  1. Edema and mPAP [ Time Frame: 4 - 48 hours ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00570245

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Hospital General La Fe
Valencia, Spain, 46009
Sponsors and Collaborators
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Principal Investigator: Rosario Vicente, MD Hospital General La Fe
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Responsible Party: Mallinckrodt Identifier: NCT00570245    
Other Study ID Numbers: VICER1
First Posted: December 10, 2007    Key Record Dates
Last Update Posted: October 19, 2016
Last Verified: October 2016
Keywords provided by Mallinckrodt:
Lung transplantation
Additional relevant MeSH terms:
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Nitric Oxide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Free Radical Scavengers
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Protective Agents