Acute Respiratory Distress SyndromeRV STARNCT01768949
Echocardiography Predictive of the Inefficacy and/or of the Unsafeness of Recruitment Maneuvers in Patients With Acute Respiratory Distress Syndrome.
A study testing Echocardiography in people with Acute Respiratory Distress Syndrome, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial summary
The purpose of the study RVSTAR is to evaluate whether echocardiographic criteria exploring the right ventricle can predict the inefficacy and/or the unsafeness of recruitment maneuvers in patients suffering from acute respiratory distress syndrome Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome
- What is being tested?
- Echocardiography
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2013to Jan 2017
- 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
- Endotracheal mechanical ventilation for acute hypoxemic respiratory failure lasting for one week or less
- A ratio of the partial pressure of arterial oxygen (PaO2 measured in millimeters of mercury) to the fraction of inspired oxygen (FiO2 which is unitless) of 300 mmHg or less and inspired fraction of oxygen FiO2 of more than 50 %
- A positive end-expiratory pressure of 5 cm of water or higher
- A tidal volume of 6 to 8 ml per kilogram of predicted body weight
- Bilateral opacities on chest radiography not fully explained by effusions, lobar/lung collapse, or nodules
- Respiratory failure not fully explained by cardiac failure or fluid overload
Show all 9Show fewer
- Written and informed consent
- Adult patients at least 18 years of age
- Ventilatory criteria (PaO2/FiO2 of 300 mmHg or less and Positive End Expiratory Pressure of 5 cm of water or higher) and radiologic criteria (Bilateral opacities on chest radiography not fully explained by effusions, lobar/lung collapse, or nodules) lasting more than 24 hours
Who cannot join
- Endotracheal mechanical ventilation for acute hypoxemic respiratory failure lasting for more than one week
- Age younger than 18 years old
- No written and informed consent
- Known pregnancy and/or breastfeeding
- Increased intracranial pressure
- A ratio of the partial pressure of arterial oxygen (PaO2 measured in millimeters of mercury) to the fraction of inspired oxygen (FiO2 which is unitless) higher than 300 mmHg
Show all 14Show fewer
- Positive end expiratory pressure of less than 5 mmHg
- Ventilatory criteria (PaO2/FiO2 of 300 mmHg or less and Positive End Expiratory Pressure of 5 cm of water or higher) and radiologic criteria (Bilateral opacities on chest radiography not fully explained by effusions, lobar/lung collapse, or nodules) lasting less than 24 hours
- Severe chronic respiratory disease requiring long-term oxygen therapy or mechanical ventilation at home
- Severe chronic liver disease
- Barotrauma such as pneumothorax
- Hemodynamic failure needing more than 3 milligrams per hour of noradrenalin and/or more than 2 milligrams per hour of adrenalin and or rising doses of vasopressors and/or vascular filling exceeding 500 milliliters in the preceding hour
- Arrhythmias such as : ventricular tachycardia, ventricular fibrillation, third degree atrioventricular block
- Atrial fibrillation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Identification of Echocardiographic Criteria Predictive of the Inefficacy and/or the Unsafeness of Recruitment Maneuvers in Patients Suffering From Acute Respiratory Distress Syndrome
The purpose of the study RVSTAR is to evaluate whether echocardiographic criteria exploring the right ventricle can predict the inefficacy and/or the unsafeness of recruitment maneuvers in patients suffering from acute respiratory distress syndrome
- Conditions
- Acute Respiratory Distress Syndrome
- Being tested
- Echocardiography
- Keywords
- Acute respiratory distress syndrome, Echocardiography, Recruitment maneuver
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EchocardiographyDevice
In the study RVSTAR, all the patients included will undergo an echocardiography in order to find an echocardiographic criterion predictive of the inefficacy and/or unsafeness of recruitment maneuver.
| Study group | Role | What they receive |
|---|---|---|
| Echocardiography | Other | An echocardiography will be systematically realised in all the patients included in the study in order to evaluate whether any echocardiographic criterion exploring the right ventricle can predict the efficacy and/or safeness of recruitment maneuvers in patients suffering from acute respiratory distress syndrome. Receives: Device: Echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy and safety of recruitment maneuvers in patients with Acute Respiratory Distress Syndrome.
A recruitment maneuver is considered effective if the partial pressure of oxygen in arterial blood PaO2 measured one hour after the completion of recruitment maneuver is 20 % higher than PaO2 before recruitment maneuver.
A recruitment maneuver is considered unsafe if systolic arterial pressure decreases 40 % under its value before recruitment maneuver and/or if systolic arterial pressure decreases under 70 mmHg and/or if arrhythmias (third degree atrio-ventricular block, ventricular tachycardia, ventricular fibrillation, atrial fibrillation)occur during the achievement of recruitment maneuver in patients suffering from Acute Respiratory Distress Syndrome.
Can echocardiography predict the inefficacy and/or unsafeness of recruitment maneuvers in patients suffering from Acute Respiratory Distress Syndrom ?
Measured: Up to 2 years
Secondary outcomes (3)
Feasibility of the measurement of Longitudinal Strain and Strain Rate of the right ventricle in patients suffering from Acute Respiratory Distress Syndrome.
Collecting echocardiographic criteria exploring the right ventricle is particularly difficult, especially in patients suffering from Acute Respiratory Distress Syndrome.
One of the aims of the study RVSTAR is to evaluate if the measurement of Longitudinal Strain and Strain Rate of the right ventricle is feasible.
At the end of the study, the feasibility of the measurement of Longitudinal Strain and Strain Rate of the right ventricle will be determined by the proportion of patients (among all the patients included) in whom these echocardiographic criteria (Longitudinal Strain and Strain Rate of the right ventricle) have been realised successfully.
Measured: Up to 2 years
Comparison of the results of echocardiographic measurements between the group CONTROL and the group FAILURE.
Is there any statistical difference in the echocardiographic measurements exploring the right ventricle in the group CONTROL (the recruitment maneuver has been safe and effective) and the group FAILURE (the recruitment maneuver has not been safe and /or has not been effective)? The echocardiographic measurements assessed (and compared between the 2 groups) will be the following ones : right heart dimensions (diameter at the base and at the mid-level of the right ventricle, longitudinal dimension of the right ventricle), right ventricle wall thickness, tricuspid annular plane systolic excursion, two-dimensional fractional area change, two-dimensional right ventricle ejection fraction,tissue Doppler-derived tricuspid lateral annular systolic velocity, longitudinal strain and strain rate, pulsed Doppler of the tricuspid inflow, tissue Doppler of the lateral tricuspid annulus, pulsed Doppler of the hepatic vein, measurements of inferior vena cava, tricuspid regurgitation velocity
Measured: Up to 2 years
Evaluate the effect of the inefficacy and/or of the unsafeness of the recruitment maneuver on the future of the patient suffering from Acute Respiratory Distress Syndrome.
One of the aims of the study RVSTAR is to evaluate if there is an effect of the inefficacy and/or the unsafeness of the recruitment maneuver on mortality (proportion of patients who died within 30 days after study enrollment), on the duration of invasive mechanical ventilation (number of days under mechanical ventilation from the study enrollment until discharge from the intensive care unit), on the length of stay in the intensive care unit (number of days spent in the intensive care unit) and on organ failure (renal failure defined by the need for renal replacement therapy, hemodynamic failure defined by the need for vascular filling exceeding 50 ml per kilogram of body weight and/or the need for vasopressors and/or for the need for rising doses of vasopressors) in patients suffering from Acute Respiratory Distress Syndrome.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2013 (estimated)
- Study startFeb 2013
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (54)Papers the sponsor has linked to this study.
- Other trials for Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guillaume BESCH, Centre Hospitalier Universitaire de Besancon
- Investigators
- Guillaume Besch, Study director, Centre Hospitalier Universitaire Besançon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01768949
- Sponsor's protocol ID
- P/2012/131
- Acronym
- RV STAR
- Status last verified
- Jan 2017
- First submitted
- 13 Jan 2013
- Last updated
- 31 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Morgan BC, Martin WE, Hornbein TF, Crawford EW, Guntheroth WG. Hemodynamic effects of intermittent positive pressure respiration. Anesthesiology. 1966 Sep-Oct;27(5):584-90. doi: 10.1097/00000542-196609000-00009. No abstract available.
PubMed 5331459Fessler HE, Brower RG, Wise RA, Permutt S. Effects of positive end-expiratory pressure on the gradient for venous return. Am Rev Respir Dis. 1991 Jan;143(1):19-24. doi: 10.1164/ajrccm/143.1.19.
PubMed 1986678Fessler HE, Brower RG, Wise RA, Permutt S. Effects of positive end-expiratory pressure on the canine venous return curve. Am Rev Respir Dis. 1992 Jul;146(1):4-10. doi: 10.1164/ajrccm/146.1.4.
PubMed 1626812WHITTENBERGER JL, McGREGOR M, BERGLUND E, BORST HG. Influence of state of inflation of the lung on pulmonary vascular resistance. J Appl Physiol. 1960 Sep;15:878-82. doi: 10.1152/jappl.1960.15.5.878. No abstract available.
PubMed 13784949Versprille A. The pulmonary circulation during mechanical ventilation. Acta Anaesthesiol Scand Suppl. 1990;94:51-62. doi: 10.1111/j.1399-6576.1990.tb03223.x. No abstract available.
PubMed 2291390Brower R, Wise RA, Hassapoyannes C, Bromberger-Barnea B, Permutt S. Effect of lung inflation on lung blood volume and pulmonary venous flow. J Appl Physiol (1985). 1985 Mar;58(3):954-63. doi: 10.1152/jappl.1985.58.3.954.
PubMed 3884583Vieillard-Baron A, Chergui K, Augarde R, Prin S, Page B, Beauchet A, Jardin F. Cyclic changes in arterial pulse during respiratory support revisited by Doppler echocardiography. Am J Respir Crit Care Med. 2003 Sep 15;168(6):671-6. doi: 10.1164/rccm.200301-135OC. Epub 2003 Jul 17.
PubMed 12869360Pinsky MR, Matuschak GM, Klain M. Determinants of cardiac augmentation by elevations in intrathoracic pressure. J Appl Physiol (1985). 1985 Apr;58(4):1189-98. doi: 10.1152/jappl.1985.58.4.1189.
PubMed 3988674Abel JG, Salerno TA, Panos A, Greyson ND, Rice TW, Teoh K, Lichtenstein SV. Cardiovascular effects of positive pressure ventilation in humans. Ann Thorac Surg. 1987 Feb;43(2):198-206. doi: 10.1016/s0003-4975(10)60396-7.
PubMed 3545111Fessler HE, Brower RG, Wise RA, Permutt S. Mechanism of reduced LV afterload by systolic and diastolic positive pleural pressure. J Appl Physiol (1985). 1988 Sep;65(3):1244-50. doi: 10.1152/jappl.1988.65.3.1244.
PubMed 3053581Ferguson ND, Fan E, Camporota L, Antonelli M, Anzueto A, Beale R, Brochard L, Brower R, Esteban A, Gattinoni L, Rhodes A, Slutsky AS, Vincent JL, Rubenfeld GD, Thompson BT, Ranieri VM. The Berlin definition of ARDS: an expanded rationale, justification, and supplementary material. Intensive Care Med. 2012 Oct;38(10):1573-82. doi: 10.1007/s00134-012-2682-1. Epub 2012 Aug 25.
PubMed 22926653Acute Respiratory Distress Syndrome Network; Brower RG, Matthay MA, Morris A, Schoenfeld D, Thompson BT, Wheeler A. Ventilation with lower tidal volumes as compared with traditional tidal volumes for acute lung injury and the acute respiratory distress syndrome. N Engl J Med. 2000 May 4;342(18):1301-8. doi: 10.1056/NEJM200005043421801.
PubMed 10793162Gattinoni L, Pesenti A. The concept of "baby lung". Intensive Care Med. 2005 Jun;31(6):776-84. doi: 10.1007/s00134-005-2627-z. Epub 2005 Apr 6.
PubMed 15812622Lachmann B. Open up the lung and keep the lung open. Intensive Care Med. 1992;18(6):319-21. doi: 10.1007/BF01694358. No abstract available.
PubMed 1469157Bond DM, McAloon J, Froese AB. Sustained inflations improve respiratory compliance during high-frequency oscillatory ventilation but not during large tidal volume positive-pressure ventilation in rabbits. Crit Care Med. 1994 Aug;22(8):1269-77. doi: 10.1097/00003246-199408000-00011.
PubMed 8045147
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Echocardiographic Criteria Predictive of the Inefficacy and/or the Unsafeness of Recruitment Maneuvers in Patients Suffering From Acute Respiratory Distress Syndrome
- ClinicalTrials.gov ID
- NCT01768949
- Acronym / sponsor ID
- RV STAR / P/2012/131
- Conditions
- Acute Respiratory Distress Syndrome
- Keywords
- Acute respiratory distress syndrome, Echocardiography, Recruitment maneuver
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 16 Jan 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.
The purpose of the study RVSTAR is to evaluate whether echocardiographic criteria exploring the right ventricle can predict the inefficacy and/or the unsafeness of recruitment maneuvers in patients suffering from acute respiratory distress syndrome
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Echocardiography | Other | Device: EchocardiographyAn echocardiography will be systematically realised in all the patients included in the study in order to evaluate whether any echocardiographic criterion exploring the right ventricle can predict the efficacy and/or safeness of recruitment maneuvers in patients suffering from acute respiratory distress syndrome. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Endotracheal mechanical ventilation for acute hypoxemic respiratory failure lasting for one week or less
- A ratio of the partial pressure of arterial oxygen (PaO2 measured in millimeters of mercury) to the fraction of inspired oxygen (FiO2 which is unitless) of 300 mmHg or less and inspired fraction of oxygen FiO2 of more than 50 %
- A positive end-expiratory pressure of 5 cm of water or higher
- A tidal volume of 6 to 8 ml per kilogram of predicted body weight
- Bilateral opacities on chest radiography not fully explained by effusions, lobar/lung collapse, or nodules
Key exclusion criteria (14 listed)
- Endotracheal mechanical ventilation for acute hypoxemic respiratory failure lasting for more than one week
- Age younger than 18 years old
- No written and informed consent
- Known pregnancy and/or breastfeeding
- Increased intracranial pressure
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 |
|---|---|---|
| EchocardiographyIn the study RVSTAR, all the patients included will undergo an echocardiography in order to find an echocardiographic criterion predictive of the inefficacy and/or unsafeness of recruitment maneuver. | Device | Echocardiography |
Primary outcome
Efficacy and safety of recruitment maneuvers in patients with Acute Respiratory Distress Syndrome.
Time frame: Up to 2 years
A recruitment maneuver is considered effective if the partial pressure of oxygen in arterial blood PaO2 measured one hour after the completion of recruitment maneuver is 20 % higher than PaO2 before recruitment maneuver. A recruitment maneuver is considered unsafe if systolic arterial pressure decreases 40 % under its value before recruitment maneuver and/or if systolic arterial pressure decreases under 70 mmHg and/or if arrhythmias (third degree atrio-ventricular block, ventricular tachycardia, ventricular fibrillation, atrial fibrillation)occur during the achievement of recruitment maneuver in patients suffering from Acute Respiratory Distress Syndrome. Can echocardiography predict the inefficacy and/or unsafeness of recruitment maneuvers in patients suffering from Acute Respiratory Distress Syndrom ?
3 secondary outcomes
Feasibility of the measurement of Longitudinal Strain and Strain Rate of the right ventricle in patients suffering from Acute Respiratory Distress Syndrome.
Time frame: Up to 2 years
Comparison of the results of echocardiographic measurements between the group CONTROL and the group FAILURE.
Time frame: Up to 2 years
Evaluate the effect of the inefficacy and/or of the unsafeness of the recruitment maneuver on the future of the patient suffering from Acute Respiratory Distress Syndrome.
Time frame: Up to 2 years
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 31 Jan 2017.
- Background: PubMed 5331459Morgan BC, Martin WE, Hornbein TF, Crawford EW, Guntheroth WG. Hemodynamic effects of intermittent positive pressure respiration. Anesthesiology. 1966 Sep-Oct;27(5):584-90. doi: 10.1097/00000542-196609000-00009. No abstract available.
- Background: PubMed 1986678Fessler HE, Brower RG, Wise RA, Permutt S. Effects of positive end-expiratory pressure on the gradient for venous return. Am Rev Respir Dis. 1991 Jan;143(1):19-24. doi: 10.1164/ajrccm/143.1.19.
- Background: PubMed 1626812Fessler HE, Brower RG, Wise RA, Permutt S. Effects of positive end-expiratory pressure on the canine venous return curve. Am Rev Respir Dis. 1992 Jul;146(1):4-10. doi: 10.1164/ajrccm/146.1.4.
- Background: PubMed 13784949WHITTENBERGER JL, McGREGOR M, BERGLUND E, BORST HG. Influence of state of inflation of the lung on pulmonary vascular resistance. J Appl Physiol. 1960 Sep;15:878-82. doi: 10.1152/jappl.1960.15.5.878. No abstract available.
- Background: PubMed 2291390Versprille A. The pulmonary circulation during mechanical ventilation. Acta Anaesthesiol Scand Suppl. 1990;94:51-62. doi: 10.1111/j.1399-6576.1990.tb03223.x. No abstract available.
- Background: PubMed 3884583Brower R, Wise RA, Hassapoyannes C, Bromberger-Barnea B, Permutt S. Effect of lung inflation on lung blood volume and pulmonary venous flow. J Appl Physiol (1985). 1985 Mar;58(3):954-63. doi: 10.1152/jappl.1985.58.3.954.
- Background: PubMed 12869360Vieillard-Baron A, Chergui K, Augarde R, Prin S, Page B, Beauchet A, Jardin F. Cyclic changes in arterial pulse during respiratory support revisited by Doppler echocardiography. Am J Respir Crit Care Med. 2003 Sep 15;168(6):671-6. doi: 10.1164/rccm.200301-135OC. Epub 2003 Jul 17.
- Background: PubMed 3988674Pinsky MR, Matuschak GM, Klain M. Determinants of cardiac augmentation by elevations in intrathoracic pressure. J Appl Physiol (1985). 1985 Apr;58(4):1189-98. doi: 10.1152/jappl.1985.58.4.1189.
- Background: PubMed 3545111Abel JG, Salerno TA, Panos A, Greyson ND, Rice TW, Teoh K, Lichtenstein SV. Cardiovascular effects of positive pressure ventilation in humans. Ann Thorac Surg. 1987 Feb;43(2):198-206. doi: 10.1016/s0003-4975(10)60396-7.
- Background: PubMed 3053581Fessler HE, Brower RG, Wise RA, Permutt S. Mechanism of reduced LV afterload by systolic and diastolic positive pleural pressure. J Appl Physiol (1985). 1988 Sep;65(3):1244-50. doi: 10.1152/jappl.1988.65.3.1244.
- Background: PubMed 22926653Ferguson ND, Fan E, Camporota L, Antonelli M, Anzueto A, Beale R, Brochard L, Brower R, Esteban A, Gattinoni L, Rhodes A, Slutsky AS, Vincent JL, Rubenfeld GD, Thompson BT, Ranieri VM. The Berlin definition of ARDS: an expanded rationale, justification, and supplementary material. Intensive Care Med. 2012 Oct;38(10):1573-82. doi: 10.1007/s00134-012-2682-1. Epub 2012 Aug 25.
- Background: PubMed 10793162Acute Respiratory Distress Syndrome Network; Brower RG, Matthay MA, Morris A, Schoenfeld D, Thompson BT, Wheeler A. Ventilation with lower tidal volumes as compared with traditional tidal volumes for acute lung injury and the acute respiratory distress syndrome. N Engl J Med. 2000 May 4;342(18):1301-8. doi: 10.1056/NEJM200005043421801.
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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.
Guillaume Besch study director
Centre Hospitalier Universitaire Besançon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Echocardiography in people with Acute Respiratory Distress Syndrome, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
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 14 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 31 Jan 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 France. 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 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?
Efficacy and safety of recruitment maneuvers in patients with Acute Respiratory Distress Syndrome. (time frame: Up to 2 years). 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 NCT01768949, which also lists 54 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 31 Jan 2017.