Safety and Efficacy Study of Nitric Oxide in Patients Going Through Lung Transplantation
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.
1 other identifier
interventional
49
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Apr 2005
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2005
CompletedFirst Submitted
Initial submission to the registry
December 6, 2007
CompletedFirst Posted
Study publicly available on registry
December 10, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2008
CompletedOctober 19, 2016
October 1, 2016
3.2 years
December 6, 2007
October 18, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Edema and mPAP
4 - 48 hours
Study Arms (3)
A
NO INTERVENTIONNeither donors or recipients will receive NO
B
ACTIVE COMPARATORDonor will not receive NO, recipient will receive up to 48 hours of NO
C
ACTIVE COMPARATORThe donor will receive NO for 3 hours and the recipient will receive NO for up to 48 hours
Interventions
Eligibility Criteria
You may qualify if:
- Have a lung graft scheduled
- Males and females aged 18 to 65
- Signed informed consent approved by the IRB/EC
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mallinckrodtlead
Study Sites (1)
Hospital General La Fe
Valencia, 46009, Spain
Related Publications (3)
Moreno I, Vicente R, Ramos F, Vicente JL, Barbera M. Determination of interleukin-6 in lung transplantation: association with primary graft dysfunction. Transplant Proc. 2007 Sep;39(7):2425-6. doi: 10.1016/j.transproceed.2007.07.056.
PMID: 17889209BACKGROUNDMoreno I, Mir A, Vicente R, Pajares A, Ramos F, Vicente JL, Barbera M. Analysis of interleukin-6 and interleukin-8 in lung transplantation: correlation with nitric oxide administration. Transplant Proc. 2008 Nov;40(9):3082-4. doi: 10.1016/j.transproceed.2008.08.124.
PMID: 19010201BACKGROUNDMoreno I, Vicente R, Mir A, Leon I, Ramos F, Vicente JL, Barbera M. Effects of inhaled nitric oxide on primary graft dysfunction in lung transplantation. Transplant Proc. 2009 Jul-Aug;41(6):2210-2. doi: 10.1016/j.transproceed.2009.05.019.
PMID: 19715875BACKGROUND
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rosario Vicente, MD
Hospital General La Fe
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 6, 2007
First Posted
December 10, 2007
Study Start
April 1, 2005
Primary Completion
June 1, 2008
Study Completion
June 1, 2008
Last Updated
October 19, 2016
Record last verified: 2016-10