Lung TransplantationPhase 2NCT00570245
Safety and Efficacy Study of Nitric Oxide in Patients Going Through Lung Transplantation
A Phase 2 study testing Nitric oxide in people with Lung Transplantation, run by Mallinckrodt at 1 site in Spain.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lung Transplantation
- What is being tested?
- Nitric oxide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteSpain
- Study dates
- Apr 2005to Jun 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have a lung graft scheduled
- Males and females aged 18 to 65
- Signed informed consent approved by the IRB/EC
Who cannot join
- 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
Show all 11Show fewer
- Severe osteoporosis
- Active peptic ulcer
- Progressive neuromuscular disease
- Active limiting systemic disease. Complicated diabetes.
- Any contraindication based on the judgement of the investigator
Trial locations and contacts
1 site in 1 country.
About this study
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.
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
Read the 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.
- Conditions
- Lung Transplantation
- Being tested
- Nitric oxide
- Keywords
- Lung transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nitric oxideDrug
inhalation, 10 ppm, for up to 48 hours
Nitric oxideDrug
inhalation; 10ppm; 3 hours (donor) up to 48 hours (recipient)
| Study group | Role | What they receive |
|---|---|---|
| A | No intervention | Neither donors or recipients will receive NO |
| B | Active comparator | Donor will not receive NO, recipient will receive up to 48 hours of NO Receives: Drug: Nitric oxide |
| C | Active comparator | The donor will receive NO for 3 hours and the recipient will receive NO for up to 48 hours Receives: Drug: Nitric oxide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Edema and mPAP
Measured: 4 - 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2007 (estimated)
- Study startApr 2005
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Lung TransplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mallinckrodt
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rosario Vicente, MD, Principal investigator, Hospital General La Fe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00570245
- Sponsor's protocol ID
- VICER1
- Status last verified
- Oct 2016
- First submitted
- 6 Dec 2007
- Last updated
- 19 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 17889209Moreno 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.
PubMed 19010201Moreno 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.
PubMed 19715875
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00570245
- Acronym / sponsor ID
- VICER1
- Conditions
- Lung Transplantation
- Keywords
- Lung transplantation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- MallinckrodtIndustry (pharma, biotech, devices)
- Study start
- Apr 2005
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 10 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | No intervention | –Neither donors or recipients will receive NO |
| B | Active comparator | Drug: Nitric oxideDonor will not receive NO, recipient will receive up to 48 hours of NO |
| C | Active comparator | Drug: Nitric oxideThe donor will receive NO for 3 hours and the recipient will receive NO for up to 48 hours |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Have a lung graft scheduled
- Males and females aged 18 to 65
- Signed informed consent approved by the IRB/EC
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nitric oxideinhalation, 10 ppm, for up to 48 hours | Drug | B |
| Nitric oxideinhalation; 10ppm; 3 hours (donor) up to 48 hours (recipient) | Drug | C |
Primary outcome
Edema and mPAP
Time frame: 4 - 48 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2016.
- Background: PubMed 17889209Moreno 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.
- Background: PubMed 19010201Moreno 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.
- Background: PubMed 19715875Moreno 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rosario Vicente, MD principal investigator
Hospital General La Fe
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nitric oxide in people with Lung Transplantation, run by Mallinckrodt at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Edema and mPAP (time frame: 4 - 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00570245, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2016.