Acute Lung InjuryALIVENCT01901354
Acute Lung Injury Ventilator Evaluation (ALIVE)
A study testing Low-tidal-volume ventilation and Airway Pressure Release Ventilation (APRV) in people with Acute Lung Injury and Adult Respiratory Distress Syndrome, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
This study will compare two ventilator modes in mechanically ventilated patients with acute lung injury. Acute lung injury (ALI) is a condition in which the lungs are badly injured and are not able to absorb oxygen the way healthy lungs do. About 25% of patients who are ventilated get ALI. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Lung Injury, Adult Respiratory Distress Syndrome
- What is being tested?
- Low-tidal-volume ventilation and Airway Pressure Release Ventilation (APRV)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to Oct 2014
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age greater than or equal to 18
- Admitted to intensive care unit
- Has legally authorized representative (LAR) available to provide informed consent in languages allowed by IRB
- Has required mechanical ventilator for less than 14 days
- Meets all of the following American-European Consensus Criteria for Acute Lung Injury or Acute Respiratory Distress Syndrome: a. Acute onset of respiratory compromise, AND b. Bilateral chest radiographic infiltrates, AND c. PaO2/FiO2 ratio less than 300, OR if no arterial blood gas has been drawn by the clinical care team, a saturation O2/FiO2 ratio less than 315 with an O2 saturation less than 97%), AND d. Known pulmonary wedge pressure less than 18 mmHg, OR if pulmonary wedge pressure is not known, left-sided heart failure is not the most likely explanation for the patient's clinical findings of bilateral infiltrates and/or low PaO2/FiO2 ratio
- Has met ALI criteria for less than 7 days prior to enrollment
Show all 9Show fewer
- Approval of intensive care unit attending physician
- Has arterial catheter in place
- Meets Clinical Stability Criteria for at least one hour prior to the start of study procedures. Note: Clinical Stability Criteria must be maintained throughout the duration of the intervention period.
Who cannot join
- Patient has a Do Not Resuscitate Order
- Evidence of increased intracranial pressure (e.g. presence of intraventricular catheter, brain herniation)
- Patient is pregnant (if pregnancy test was not performed as part of routine clinical care, a urine pregnancy test must be performed for women of childbearing potential after informed consent obtained)
- Planned transport out of ICU during study protocol
- Coagulopathy within the past 48 hours (INR greater than 2.0 or PTT greater than 50 seconds)
- Severe thrombocytopenia within the past 48 hours (platelets less than 20,000 per μL)
- History of obstructive lung disease (asthma and/or COPD)
- Patients who are currently prisoners
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin-Madison
Madison, Wisconsin, 53792
About this study
Official title: Acute Lung Injury Ventilator Evaluation (ALIVE) Trial: Biomarkers of Lung Injury With Low Tidal Volume Ventilation Compared With Airway Pressure Release Ventilation in Trauma Patients
This study will compare two ventilator modes in mechanically ventilated patients with acute lung injury.
Acute lung injury (ALI) is a condition in which the lungs are badly injured and are not able to absorb oxygen the way healthy lungs do. About 25% of patients who are ventilated get ALI. ALI causes 75,000 deaths in the US each year.
Ventilators can be set to work in different ways, called modes. One mode, called ARDSNet, pumps a small amount of air into the patient's lungs and then most of the air is released prior to the next breath. Another mode, called Airway pressure release ventilation (APRV), keeps air in the lungs longer between breaths. Both of these modes are currently used at this hospital. The investigators think APRV may help patients with ALI, but we do not know for sure.
Read the detailed description
Acute lung injury (ALI) and the acute respiratory distress syndrome (ARDS) represent a spectrum of clinical syndromes of rapid respiratory system deterioration that are associated with both pulmonary and systemic illness. These syndromes are associated with 30-40% mortality with our current standard of care and are responsible for approximately 75,000 deaths in the US yearly. The current evidence-based care consists of a strategy of mechanical ventilation utilizing low lung volumes (ARDSNet ventilation) intended to limit further lung injury from overstretch of the lung induced by the ventilator. However, this strategy has been shown to be associated with continued lung injury in some studies and still is associated with about a 30% mortality rate. Airway pressure release ventilation (APRV) is a different, nonexperimental strategy of mechanical ventilation currently in routine clinical use. APRV allows a patient a greater degree of autonomy in controlling his/her breathing while achieving a higher mean airway pressure (at similar plateau pressures) than that typically achieved with ARDSNet. APRV has been associated with less ventilator-associated pneumonia, better oxygenation, and less sedative usage in small studies when compared with other methods of ventilation. However, debate exists over net effects of APRV with regard to ventilator-associated lung injury. Additionally, we recently completed a study showing that APRV was associated with lower ventilator associated pneumonia (VAP) rates, but this benefit did not appear to be mediated by sedation differences. We hypothesized that the VAP benefits might be mediated by greater lung recruitment and possibly less ventilator-induced lung injury with APRV. We propose a randomized, crossover study looking at biomarkers of lung injury in patients with acute lung injury ventilated with APRV and ARDSNet. Our hypothesis is that airway pressure release ventilation is associated with lower levels of lung injury biomarkers than ARDSNet ventilation.
- Being tested
- Low-tidal-volume ventilation, Airway Pressure Release Ventilation (APRV)
- Keywords
- Acute lung injury (ALI), Adult respiratory distress syndrome (ARDS), Low-tidal-volume strategy, ARDSNet, airway pressure release ventilation (APRV), biomarkers of lung injury
- Medical subject headings
- Acute Lung Injury, Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-tidal-volume ventilationOther
Goal tidal volume is 6 cc/kg ideal body weight.
Airway Pressure Release Ventilation (APRV)Other
APRV is a time cycled, inverse-ratio, pressure controlled strategy that allows spontaneous breathing through the respiratory cycle.
| Study group | Role | What they receive |
|---|---|---|
| Low-tidal-volume ventilation | Active comparator | Subjects will be ventilated with a goal tidal volume of 6 cc/kg predicted body weight (PBW), a goal plateau pressure of <30 cm H2O, and a goal respiratory rate of 6-35 bpm to achieve a goal arterial pH of 7.30 to 7.45. Positive end-expiratory pressure is set as per the ARDSNet Positive end-expiratory pressure table Receives: Other: Low-tidal-volume ventilation |
| Airway pressure release ventilation (APRV) | Active comparator | Airway Pressure Release Ventilation (APRV) is a time cycled, inverse-ratio, pressure controlled strategy that allows spontaneous breathing throughout the respiratory cycle.
Initial settings: Pressure high will be set initially to equal the plateau pressure on baseline ARDSNet settings. Time low will be set to 0.5-0.8 seconds to achieve an end expiratory flow 25-50% of peak expiratory flow, and Time high will be set to obtain a set respiratory rate 60%-70% that of baseline settings. Time high will be adjusted to achieve similar continuous exhaled carbon dioxide levels as baseline ARDSNet settings. Low pressure will be set at <5 cm H20. Receives: Other: Airway Pressure Release Ventilation (APRV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of APRV and ARDSNet ventilator modes upon plasma expression of Interleukin-6 (IL-6)
We will assess the impact of APRV and ARDSNet ventilator modes upon plasma expression of Interleukin-6(IL-6), a biomarker that has been shown to correlate with degree of lung inflammation. The study will be powered to detect a decrease in plasma IL-6 levels (pg/mL) from ARDSNet to APRV.
Measured: Baseline, Hour 6, Hour 12
Secondary outcomes (12)
Impact of APRV and ARDSNet ventilator modes upon plasma expression of Soluble receptors of tumor necrosis factor alpha (sTNFa-R1)
We will assess the impact of APRV and ARDSNet ventilator modes upon plasma expression of Soluble receptors of tumor necrosis factor alpha (sTNFa-R1) that we speculate will correlate with degree of lung inflammation.
Measured: Baseline, Hour 6, Hour 12
Impact of APRV and ARDSNet ventilator modes upon static lung compliance (L/cmH2O).
Static lung compliance in L/cmH2O will be recorded for each subject at baseline, Hour 6 and Hour 12. We will assess the impact of APRV and ARDSNet ventilator modes upon static lung compliance by comparing change from baseline measurement to Hour 6 measurement with change from baseline measurement to Hour 12 measurement.
Measured: Baseline, Hour 6, Hour 12
Impact of APRV and ARDSNet ventilator modes upon plasma expression of Interleukin-8 (IL-8)
We will assess the impact of APRV and ARDSNet ventilator modes upon plasma expression of Interleukin-8 (IL-8) that we speculate will correlate with degree of lung inflammation.
Measured: Baseline, Hour 6, Hour 12
Impact of APRV and ARDSNet ventilator modes upon plasma expression of Interleukin-1 receptor antagonist (IL1-r-a)
We will assess the impact of APRV and ARDSNet ventilator modes upon plasma expression of Interleukin-1 receptor antagonist (IL1-r-a) that we speculate will correlate with degree of lung inflammation.
Measured: Baseline, Hour 6, Hour 12
Impact of APRV and ARDSNet ventilator modes upon plasma expression of Surfactant, pulmonary-associated protein D (SP-D)
We will assess the impact of APRV and ARDSNet ventilator modes upon plasma expression of Surfactant, pulmonary-associated protein D (SP-D) that we speculate will correlate with degree of lung inflammation.
Measured: Baseline, 6 Hours, 12 Hours
Impact of APRV and ARDSNet ventilator modes upon Oxygenation (PaO2)
We will assess the impact of APRV and ARDSNet ventilator modes upon Oxygenation (PaO2).
Measured: Baseline, Hour 6, Hour 12
Impact of APRV and ARDSNet ventilator modes upon Ventilation (PaCO2)
We will assess the impact of APRV and ARDSNet ventilator modes upon Ventilation (PaCO2).
Measured: Baseline, Hour 6, Hour 12
Impact of APRV and ARDSNet ventilator modes upon Tissue metabolism (lactate)
We will assess the impact of APRV and ARDSNet ventilator modes upon Tissue metabolism (lactate).
Measured: Baseline, Hour 6, Hour 12
Impact of APRV and ARDSNet ventilator modes upon Non-spontaneous tidal volumes
We will assess the impact of APRV and ARDSNet ventilator modes upon non-spontaneous tidal volumes.
Measured: Baseline, Hour 6, Hour 12
Impact of APRV and ARDSNet ventilator modes upon sedation utilized
We will assess the impact of APRV and ARDSNet ventilator modes upon sedation utilized.
Measured: Baseline, Hour 6, Hour 12
Impact of APRV and ARDSNet ventilator modes upon Riker Sedation-Agitation Scale score
Agitation will be recorded according to the Riker Sedation-Agitation Scale on a scale of 1 to 7 (un-arousable to dangerous agitation) for each subject at baseline, Hour 6 and Hour 12. We will assess the impact of APRV and ARDSNet ventilator modes upon Riker Sedation-Agitation Score by comparing change from baseline measurement to Hour 6 measurement with change from baseline measurement to Hour 12 measurement.
Measured: Baseline, Hour 6, Hour 12
Impact of APRV and ARDSNet ventilator modes upon Cardiac output
Cardiac output will be recorded for each subject at sites with appropriate equipment at baseline, Hour 6 and Hour 12. The unit of measure for cardiac output will depend on the equipment used to measure the subject. However, the same equipment will be used for each subject, so the following will be calculable: change from baseline measurement to Hour 6 measurement with change from baseline measurement to Hour 12 measurement.
Measured: Baseline, Hour 6, Hour 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2013 (estimated)
- Study startNov 2013
- Primary completionOct 2014
- Study completionOct 2014
Why it stopped: Lead Investigator no longer at Institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lung InjuryStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Suresh Agarwal, MD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01901354
- Sponsor's protocol ID
- 2012-0887
- Acronym
- ALIVE
- Status last verified
- Sep 2017
- First submitted
- 18 Jun 2013
- Last updated
- 28 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Lung Injury Ventilator Evaluation (ALIVE) Trial: Biomarkers of Lung Injury With Low Tidal Volume Ventilation Compared With Airway Pressure Release Ventilation in Trauma Patients
- ClinicalTrials.gov ID
- NCT01901354
- Acronym / sponsor ID
- ALIVE / 2012-0887
- Keywords
- Acute lung injury (ALI), Adult respiratory distress syndrome (ARDS), Low-tidal-volume strategy, ARDSNet, airway pressure release ventilation (APRV), biomarkers of lung injury
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lead Investigator no longer at Institution
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- Nov 2013 (actual)
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 17 Jul 2013 (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.
This study will compare two ventilator modes in mechanically ventilated patients with acute lung injury.
Acute lung injury (ALI) is a condition in which the lungs are badly injured and are not able to absorb oxygen the way healthy lungs do. About 25% of patients who are ventilated get ALI. ALI causes 75,000 deaths in the US each year.
Ventilators can be set to work in different ways, called modes. One mode, called ARDSNet, pumps a small amount of air into the patient's lungs and then most of the air is released prior to the next breath. Another mode, called Airway pressure release ventilation (APRV), keeps air in the lungs longer between breaths. Both of these modes are currently used at this hospital. The investigators think APRV may help patients with ALI, but we do not know for sure.
Detailed description
Acute lung injury (ALI) and the acute respiratory distress syndrome (ARDS) represent a spectrum of clinical syndromes of rapid respiratory system deterioration that are associated with both pulmonary and systemic illness. These syndromes are associated with 30-40% mortality with our current standard of care and are responsible for approximately 75,000 deaths in the US yearly. The current evidence-based care consists of a strategy of mechanical ventilation utilizing low lung volumes (ARDSNet ventilation) intended to limit further lung injury from overstretch of the lung induced by the ventilator. However, this strategy has been shown to be associated with continued lung injury in some studies and still is associated with about a 30% mortality rate. Airway pressure release ventilation (APRV) is a different, nonexperimental strategy of mechanical ventilation currently in routine clinical use. APRV allows a patient a greater degree of autonomy in controlling his/her breathing while achieving a higher mean airway pressure (at similar plateau pressures) than that typically achieved with ARDSNet. APRV has been associated with less ventilator-associated pneumonia, better oxygenation, and less sedative usage in small studies when compared with other methods of ventilation. However, debate exists over net effects of APRV with regard to ventilator-associated lung injury. Additionally, we recently completed a study showing that APRV was associated with lower ventilator associated pneumonia (VAP) rates, but this benefit did not appear to be mediated by sedation differences. We hypothesized that the VAP benefits might be mediated by greater lung recruitment and possibly less ventilator-induced lung injury with APRV. We propose a randomized, crossover study looking at biomarkers of lung injury in patients with acute lung injury ventilated with APRV and ARDSNet. Our hypothesis is that airway pressure release ventilation is associated with lower levels of lung injury biomarkers than ARDSNet ventilation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-tidal-volume ventilation | Active comparator | Other: Low-tidal-volume ventilationSubjects will be ventilated with a goal tidal volume of 6 cc/kg predicted body weight (PBW), a goal plateau pressure of <30 cm H2O, and a goal respiratory rate of 6-35 bpm to achieve a goal arterial pH of 7.30 to 7.45. Positive end-expiratory pressure is set as per the ARDSNet Positive end-expiratory pressure table |
| Airway pressure release ventilation (APRV) | Active comparator | Other: Airway Pressure Release Ventilation (APRV)Airway Pressure Release Ventilation (APRV) is a time cycled, inverse-ratio, pressure controlled strategy that allows spontaneous breathing throughout the respiratory cycle. Initial settings: Pressure high will be set initially to equal the plateau pressure on baseline ARDSNet settings. Time low will be set to 0.5-0.8 seconds to achieve an end expiratory flow 25-50% of peak expiratory flow, and Time high will be set to obtain a set respiratory rate 60%-70% that of baseline settings. Time high will be adjusted to achieve similar continuous exhaled carbon dioxide levels as baseline ARDSNet settings. Low pressure will be set at <5 cm H20. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age greater than or equal to 18
- Admitted to intensive care unit
- Has legally authorized representative (LAR) available to provide informed consent in languages allowed by IRB
- Has required mechanical ventilator for less than 14 days
- Meets all of the following American-European Consensus Criteria for Acute Lung Injury or Acute Respiratory Distress Syndrome: a. Acute onset of respiratory compromise, AND b. Bilateral chest radiographic infiltrates, AND c. PaO2/FiO2 ratio less than 300, OR if no arterial blood gas has been drawn by the clinical care team, a saturation O2/FiO2 ratio less than 315 with an O2 saturation less than 97%), AND d. Known pulmonary wedge pressure less than 18 mmHg, OR if pulmonary wedge pressure is not known, left-sided heart failure is not the most likely explanation for the patient's clinical findings of bilateral infiltrates and/or low PaO2/FiO2 ratio
Key exclusion criteria (8 listed)
- Patient has a Do Not Resuscitate Order
- Evidence of increased intracranial pressure (e.g. presence of intraventricular catheter, brain herniation)
- Patient is pregnant (if pregnancy test was not performed as part of routine clinical care, a urine pregnancy test must be performed for women of childbearing potential after informed consent obtained)
- Planned transport out of ICU during study protocol
- Coagulopathy within the past 48 hours (INR greater than 2.0 or PTT greater than 50 seconds)
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 |
|---|---|---|
| Low-tidal-volume ventilationGoal tidal volume is 6 cc/kg ideal body weight. | Other | Low-tidal-volume ventilation |
| Airway Pressure Release Ventilation (APRV)APRV is a time cycled, inverse-ratio, pressure controlled strategy that allows spontaneous breathing through the respiratory cycle. | Other | Airway pressure release ventilation (APRV) |
Primary outcome
Impact of APRV and ARDSNet ventilator modes upon plasma expression of Interleukin-6 (IL-6)
Time frame: Baseline, Hour 6, Hour 12
We will assess the impact of APRV and ARDSNet ventilator modes upon plasma expression of Interleukin-6(IL-6), a biomarker that has been shown to correlate with degree of lung inflammation. The study will be powered to detect a decrease in plasma IL-6 levels (pg/mL) from ARDSNet to APRV.
12 secondary outcomes
Impact of APRV and ARDSNet ventilator modes upon plasma expression of Soluble receptors of tumor necrosis factor alpha (sTNFa-R1)
Time frame: Baseline, Hour 6, Hour 12
Impact of APRV and ARDSNet ventilator modes upon static lung compliance (L/cmH2O).
Time frame: Baseline, Hour 6, Hour 12
Impact of APRV and ARDSNet ventilator modes upon plasma expression of Interleukin-8 (IL-8)
Time frame: Baseline, Hour 6, Hour 12
Impact of APRV and ARDSNet ventilator modes upon plasma expression of Interleukin-1 receptor antagonist (IL1-r-a)
Time frame: Baseline, Hour 6, Hour 12
Impact of APRV and ARDSNet ventilator modes upon plasma expression of Surfactant, pulmonary-associated protein D (SP-D)
Time frame: Baseline, 6 Hours, 12 Hours
Impact of APRV and ARDSNet ventilator modes upon Oxygenation (PaO2)
Time frame: Baseline, Hour 6, Hour 12
Impact of APRV and ARDSNet ventilator modes upon Ventilation (PaCO2)
Time frame: Baseline, Hour 6, Hour 12
Impact of APRV and ARDSNet ventilator modes upon Tissue metabolism (lactate)
Time frame: Baseline, Hour 6, Hour 12
Impact of APRV and ARDSNet ventilator modes upon Non-spontaneous tidal volumes
Time frame: Baseline, Hour 6, Hour 12
Impact of APRV and ARDSNet ventilator modes upon sedation utilized
Time frame: Baseline, Hour 6, Hour 12
Impact of APRV and ARDSNet ventilator modes upon Riker Sedation-Agitation Scale score
Time frame: Baseline, Hour 6, Hour 12
Impact of APRV and ARDSNet ventilator modes upon Cardiac output
Time frame: Baseline, Hour 6, Hour 12
Results and safety
The study was stopped early (reason given: Lead Investigator no longer at Institution). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2017.
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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.
Suresh Agarwal, MD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-tidal-volume ventilation and Airway Pressure Release Ventilation (APRV) in people with Acute Lung Injury and Adult Respiratory Distress Syndrome, run by University of Wisconsin, Madison at 1 site in United States.
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 9 inclusion and 8 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: stopped early, as of the sponsor's last update on 28 Sep 2017. 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 United States. 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.
Are results available for this study?
The study was stopped early (reason given: Lead Investigator no longer at Institution). Results are not available in the source record.
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?
Impact of APRV and ARDSNet ventilator modes upon plasma expression of Interleukin-6 (IL-6) (time frame: Baseline, Hour 6, Hour 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Sep 2017.