Hemodynamic InstabilityNCT03267160
A Study of Exosome Proteomics and Hemodynamics in Sepsis
An observational study of Hemodynamic Instability and Autophagy, run by Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation at 1 site in Taiwan.
Trial summary
This research will be the first study for exosomes purified in blood and urine from septic patients who had multiple organ failures. Proteomics studies in exosomes from blood or urine specimens. Analyze autophage, and apoptosis related biomarkers of exosomes by bioinformatics. Read more about this study
- Who is it for?
- Ages 20 to 99 years
- Conditions the study is for
- Hemodynamic Instability, Autophagy
- What is being tested?
- Hemodynamic parameters
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- 18 Jan 2017to 30 Jan 2020
- Phase
- Observational
- 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 20 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Sepsis was defined as a life-threatening organ dysfunction due to a dysregulated host response to infection. Patient with sepsis who was admitted to ICU. PiCCO hemodynamics was setted
Who may be able to join
- Patients with sepsis who admit to ICU
- Sepsis diagnostic criteria: acute change in total SOFA score ≥ 2 points attributable to infection
- Pulse indicator continuous cardiac output monitor (PiCCO) is accept by patient for hemodynamic monitoring
Who cannot join
- Patients with acute SOFA changes < 2 points are excluded
- auria, no urine can be collected
- Previous cardiopulmonary co-morbidity. Chronic respiratory failure with ventilator dependence and chronic heart failure.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Taipei, 23142
About this study
Official title: An Observation Study of Exosome Proteomics Released From Cardiopulmonary Organs and Hemodynamic Parameters in Sepsis
This research will be the first study for exosomes purified in blood and urine from septic patients who had multiple organ failures. Proteomics studies in exosomes from blood or urine specimens. Analyze autophage, and apoptosis related biomarkers of exosomes by bioinformatics. To find the correlations between exosomes biomarkers and hemodynamic parameters.
Read the detailed description
Background: Sepsis, defined as an infection with evidence of systemic infection, continues to be a source of considerable morbidity and mortality. Many animal sepsis models had found that sepsis induced multiple organ failure. Autophagy, apoptosis may involve the process of sepsis related multiple organ failure. Mass spectrometry-based proteomics studies in clinical populations and in rodent and mammalian animal models had started with discovered many novel biomarkers of sepsis. Esoxomes had been found in blood or urine presented the signal of autophagy and apoptosis. On the other hand, pulse contour cardiac output (PiCCO) can calculate hemodynamic parameters that had been used for evaluation in cardiopulmonary failure of sepsis.
Aims of the study: This research will be the first study for exosomes purified in blood and urine from septic patients who had multiple organ failures. Proteomics studies in exosomes from blood or urine specimens. Analyze autophage, and apoptosis related biomarkers of exosomes by bioinformatics. To find the correlations between exosomes biomarkers and hemodynamic parameters.
Materials and Methods: A total of 30 patients with sepsis, septic shock, or multiple organ failure will be included, of whom 15 septic patients had cardiopulmonary organ failure, others will be not. All patients included and classified according to the surviving sepsis campaign criteria, also treat according to surviving sepsis campaign guidelines. Data will be collected from January 2016 to December 2016. Exosome will be isolated and purified by sucrose gradient ultracentrifugation. Magnetic beads purification, 2D gel electrphoresis, and MALDI-TOF will be used to analyze proteomics of exosome in urine or blood of septic patients. Western blotting will be done to prove the proteins found by proteomics. Pulse contour cardiac output monitored heart contractility, end-diastolic volume parameters, and lung water parameters. Finally, to find the correlations between exosome specific organ and autophagy-apoptosis biomarkers and hemodynamic parameters.
Possible effect: Systematic establishment of exosome proteomics in blood and urine from septic patients who had multiple organ failure or not will be done. Autophagy-apoptosis biomarkers in exosomes will be detected and correlated to hemodynamic parameters, to judge specific organ failure in sepsis.
- Conditions
- Hemodynamic Instability, Autophagy
- Being tested
- Hemodynamic parameters
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hemodynamic parametersDiagnostic test
Pulse contour cardiac output monitored heart contractility, end-diastolic volume parameters, and lung water parameters.
| Study group | Role | What they receive |
|---|---|---|
| Sepsis with cardiopulmonary failure | Patient with sepsis and also respiratory and heart involvement, confirmed by Hemodynamic parameters Receives: Diagnostic Test: Hemodynamic parameters | |
| Sepsis without cardiopulmonary failure | Patient with sepsis without respiratory and heart involvement Receives: Diagnostic Test: Hemodynamic parameters |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of hemodynamic parameters (heart contractility: CFI)
Change from Baseline Cardiac function index (CFI; L/min) at 6 hours. Cardiac function index (CFI; L/min) will be calculated by thermodilution method. PiCCO2 device (Pulsion Medical Systems, Munich, Germany)
Measured: Baseline, 6 hours
Change of hemodynamic parameters (preload: GEDI)
Change from Baseline Global end-diastolic index (GEDI; mL/m2) at 6 hours. Global end-diastolic index (GEDI; mL/m2) will be calculated by thermodilution method. PiCCO2 device (Pulsion Medical Systems, Munich, Germany).
Measured: Baseline, 6 hours
Change of hemodynamic parameters (afterload: SVRI)
Change from Baseline Systemic vascular resistance index (SVRI; dynes x sec x cm-5/m2) at 6 hours. Systemic vascular resistance index (SVRI; dynes x sec x cm-5/m2) will be calculated by thermodilution method. PiCCO2 device (Pulsion Medical Systems, Munich, Germany).
Measured: Baseline, 6 hours
Change of hemodynamic parameters (fluid responsiveness: SVV)
Change from Baseline Stroke volume variation (SVV, %) at 6 hours. Stroke volume variation (SVV, %) will be calculated spontaneously by PiCCO2 device (Pulsion Medical Systems, Munich, Germany).
Measured: Baseline, 6 hours, one day, and 3 days
Change of hemodynamic parameters (lung water: ELWI)
Change from Baseline Extravascular lung water index (EVLWI; mL/kg) at 6 hours. Extravascular lung water index (EVLWI; mL/kg) will be calculated by the PiCCO device (Pulsion Medical Systems, Munich, Germany). EVLWI means total water in lung tissue, it increase in pulmonary edema or ARDS. PVPI means pulmonary vascular permeability and always high in ARDS (acute respiratory distress syndrome)
Measured: Baseline, 6 hours
Change of hemodynamic parameters (lung permeability: PVPI)
Change from Baseline pulmonary vascular permeability index (PVPI; ratio) at 6 hours. pulmonary vascular permeability index (PVPI) will be calculated by the PiCCO device (Pulsion Medical Systems, Munich, Germany). EVLWI means total water in lung tissue, it increase in pulmonary edema or ARDS. PVPI means pulmonary vascular permeability and always high in ARDS (acute respiratory distress syndrome)
Measured: Baseline, 6 hours
Secondary outcomes (15)
Autophagy biomarkers in exosomes: LC3II (Western blots)
LC3II appear during phagosome-lysomone fusion. Exosome will be collected from serum of sepsis. LC3II will be detected and identified by Western blots.
Measured: 6 hours
Autophagy biomarkers in exosomes: LC3II (NTA)
LC3II appear during phagosome-lysomone fusion. Exosome will be collected from serum of sepsis. Later, LC3II will be marked and combined analysis by Nanoparticle tracing analysis. Concentrations (particles/mL) by size (nm) or Intensity (a.u.) by size (nm)
Measured: 6 hours
Autophagy modifiers in exosomes: mTOR (Western blots)
mammalian target of rapamycin (mTOR) may modulate the process of autophagy. Exosome will be collected from serum of sepsis. mTOR will be detected and identified by Western blots.
Measured: 6 hours
Autophagy modifiers in exosomes: mTOR (NTA)
mammalian target of rapamycin (mTOR) may modulate the process of autophagy. Exosome will be collected from serum of sepsis. mTOR will be marked and combined analysis by Nanoparticle tracing analysis. Concentrations (particles/mL) by size (nm) or Intensity (a.u.) by size (nm)
Measured: 6 hours
Autophagy modifiers in exosomes: HSP70 (Western blots)
heat-shock protein 70 (HSP70) may modulate the process of autophagy. Exosome will be collected from serum of sepsis. HSP70 will be detected and identified by Western blots.
Measured: 6 hours
Autophagy modifiers in exosomes: HSP70 (NTA)
heat-shock protein 70 (HSP70) may modulate the process of autophagy. Exosome will be collected from serum of sepsis. Later, HSP70 will be marked and combined analysis by Nanoparticle tracing analysis. Concentrations (particles/mL) by size (nm) or Intensity (a.u.) by size (nm)
Measured: 6 hours
Autophagy modifiers in exosomes: sequestosome 1 (Western blots)
sequestosome 1 (SQSMT1/p62) may modulate the process of autophagy. Exosome will be collected from serum of sepsis. sequestosome 1 will be detected and identified by Western blots.
Measured: 6 hours
Autophagy modifiers in exosomes: sequestosome 1 (NTA)
sequestosome 1 (SQSMT1/p62) may modulate the process of autophagy. Exosome will be collected from serum of sepsis. Later, sequestosome 1 will be marked and combined analysis by Nanoparticle tracing analysis. Concentrations (particles/mL) by size (nm) or Intensity (a.u.) by size (nm)
Measured: 6 hours
Exosomes marker: CD9 (Western blots)
CD9 is the exosome surface marker. Exosome will be collected from serum of sepsis. CD9 will be detected and identified by Western blots.
Measured: 6 hours
Exosomes marker: CD9 (NTA)
CD9 is the exosome surface marker. Exosome will be collected from serum of sepsis. Later, CD9 will be marked and combined analysis by Nanoparticle tracing analysis. Concentrations (particles/mL) by size (nm) or Intensity (a.u.) by size (nm)
Measured: 6 hours
ICU mortality
ICU mortality (%), mortality during ICU admission/total ICU admission
Measured: Up to 30 days
28-day mortality
28-day mortality (%), mortality during 28-day/total 28-day admission
Measured: Up to 28 days
Hospital mortality
Hospital mortality (%), mortality during hospitalizaiton/total hospital admission
Measured: Up to 90 days
Length of stay in ICU
Length of stay in ICU (days)
Measured: Up to 30 days
Length of stay in hospital
Length of stay in hospital (days)
Measured: Up top 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2017
- Study start18 Jan 2017
- Primary completion30 Jan 2020
- Study completion30 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hemodynamic InstabilityStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wen-Lin Su, PhD, Study director, Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Taipei Tzu Chi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03267160
- Sponsor's protocol ID
- 05-XD15-039
- Status last verified
- Feb 2021
- First submitted
- 1 Aug 2017
- Last updated
- 10 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lo S, Yuan SS, Hsu C, Cheng YJ, Chang YF, Hsueh HW, Lee PH, Hsieh YC. Lc3 over-expression improves survival and attenuates lung injury through increasing autophagosomal clearance in septic mice. Ann Surg. 2013 Feb;257(2):352-63. doi: 10.1097/SLA.0b013e318269d0e2.
PubMed 22968077Gao M, Ha T, Zhang X, Wang X, Liu L, Kalbfleisch J, Singh K, Williams D, Li C. The Toll-like receptor 9 ligand, CpG oligodeoxynucleotide, attenuates cardiac dysfunction in polymicrobial sepsis, involving activation of both phosphoinositide 3 kinase/Akt and extracellular-signal-related kinase signaling. J Infect Dis. 2013 May 1;207(9):1471-9. doi: 10.1093/infdis/jit036. Epub 2013 Jan 28.
PubMed 23359590
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observation Study of Exosome Proteomics Released From Cardiopulmonary Organs and Hemodynamic Parameters in Sepsis
- ClinicalTrials.gov ID
- NCT03267160
- Acronym / sponsor ID
- 05-XD15-039
- Conditions
- Hemodynamic Instability, Autophagy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical FoundationUniversity, hospital or other
- Study start
- 18 Jan 2017 (actual)
- Primary completion
- 30 Jan 2020 (actual)
- Study completion
- 30 Jan 2020 (actual)
- First posted
- 30 Aug 2017 (actual)
- 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 research will be the first study for exosomes purified in blood and urine from septic patients who had multiple organ failures. Proteomics studies in exosomes from blood or urine specimens. Analyze autophage, and apoptosis related biomarkers of exosomes by bioinformatics. To find the correlations between exosomes biomarkers and hemodynamic parameters.
Detailed description
Background: Sepsis, defined as an infection with evidence of systemic infection, continues to be a source of considerable morbidity and mortality. Many animal sepsis models had found that sepsis induced multiple organ failure. Autophagy, apoptosis may involve the process of sepsis related multiple organ failure. Mass spectrometry-based proteomics studies in clinical populations and in rodent and mammalian animal models had started with discovered many novel biomarkers of sepsis. Esoxomes had been found in blood or urine presented the signal of autophagy and apoptosis. On the other hand, pulse contour cardiac output (PiCCO) can calculate hemodynamic parameters that had been used for evaluation in cardiopulmonary failure of sepsis.
Aims of the study: This research will be the first study for exosomes purified in blood and urine from septic patients who had multiple organ failures. Proteomics studies in exosomes from blood or urine specimens. Analyze autophage, and apoptosis related biomarkers of exosomes by bioinformatics. To find the correlations between exosomes biomarkers and hemodynamic parameters.
Materials and Methods: A total of 30 patients with sepsis, septic shock, or multiple organ failure will be included, of whom 15 septic patients had cardiopulmonary organ failure, others will be not. All patients included and classified according to the surviving sepsis campaign criteria, also treat according to surviving sepsis campaign guidelines. Data will be collected from January 2016 to December 2016. Exosome will be isolated and purified by sucrose gradient ultracentrifugation. Magnetic beads purification, 2D gel electrphoresis, and MALDI-TOF will be used to analyze proteomics of exosome in urine or blood of septic patients. Western blotting will be done to prove the proteins found by proteomics. Pulse contour cardiac output monitored heart contractility, end-diastolic volume parameters, and lung water parameters. Finally, to find the correlations between exosome specific organ and autophagy-apoptosis biomarkers and hemodynamic parameters.
Possible effect: Systematic establishment of exosome proteomics in blood and urine from septic patients who had multiple organ failure or not will be done. Autophagy-apoptosis biomarkers in exosomes will be detected and correlated to hemodynamic parameters, to judge specific organ failure in sepsis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sepsis with cardiopulmonary failure | – | Diagnostic Test: Hemodynamic parametersPatient with sepsis and also respiratory and heart involvement, confirmed by Hemodynamic parameters |
| Sepsis without cardiopulmonary failure | – | Diagnostic Test: Hemodynamic parametersPatient with sepsis without respiratory and heart involvement |
Who may qualify
- Ages
- 20 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Sepsis was defined as a life-threatening organ dysfunction due to a dysregulated host response to infection. Patient with sepsis who was admitted to ICU. PiCCO hemodynamics was setted
Key inclusion criteria (3 listed)
- Patients with sepsis who admit to ICU
- Sepsis diagnostic criteria: acute change in total SOFA score ≥ 2 points attributable to infection
- Pulse indicator continuous cardiac output monitor (PiCCO) is accept by patient for hemodynamic monitoring
Key exclusion criteria (3 listed)
- Patients with acute SOFA changes < 2 points are excluded
- auria, no urine can be collected
- Previous cardiopulmonary co-morbidity. Chronic respiratory failure with ventilator dependence and chronic heart failure.
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 |
|---|---|---|
| Hemodynamic parametersPulse contour cardiac output monitored heart contractility, end-diastolic volume parameters, and lung water parameters. | Diagnostic test | Sepsis with cardiopulmonary failure, Sepsis without cardiopulmonary failure |
Primary outcome
Change of hemodynamic parameters (heart contractility: CFI)
Time frame: Baseline, 6 hours
Change from Baseline Cardiac function index (CFI; L/min) at 6 hours. Cardiac function index (CFI; L/min) will be calculated by thermodilution method. PiCCO2 device (Pulsion Medical Systems, Munich, Germany)
Change of hemodynamic parameters (preload: GEDI)
Time frame: Baseline, 6 hours
Change from Baseline Global end-diastolic index (GEDI; mL/m2) at 6 hours. Global end-diastolic index (GEDI; mL/m2) will be calculated by thermodilution method. PiCCO2 device (Pulsion Medical Systems, Munich, Germany).
Change of hemodynamic parameters (afterload: SVRI)
Time frame: Baseline, 6 hours
Change from Baseline Systemic vascular resistance index (SVRI; dynes x sec x cm-5/m2) at 6 hours. Systemic vascular resistance index (SVRI; dynes x sec x cm-5/m2) will be calculated by thermodilution method. PiCCO2 device (Pulsion Medical Systems, Munich, Germany).
Change of hemodynamic parameters (fluid responsiveness: SVV)
Time frame: Baseline, 6 hours, one day, and 3 days
Change from Baseline Stroke volume variation (SVV, %) at 6 hours. Stroke volume variation (SVV, %) will be calculated spontaneously by PiCCO2 device (Pulsion Medical Systems, Munich, Germany).
Change of hemodynamic parameters (lung water: ELWI)
Time frame: Baseline, 6 hours
Change from Baseline Extravascular lung water index (EVLWI; mL/kg) at 6 hours. Extravascular lung water index (EVLWI; mL/kg) will be calculated by the PiCCO device (Pulsion Medical Systems, Munich, Germany). EVLWI means total water in lung tissue, it increase in pulmonary edema or ARDS. PVPI means pulmonary vascular permeability and always high in ARDS (acute respiratory distress syndrome)
Change of hemodynamic parameters (lung permeability: PVPI)
Time frame: Baseline, 6 hours
Change from Baseline pulmonary vascular permeability index (PVPI; ratio) at 6 hours. pulmonary vascular permeability index (PVPI) will be calculated by the PiCCO device (Pulsion Medical Systems, Munich, Germany). EVLWI means total water in lung tissue, it increase in pulmonary edema or ARDS. PVPI means pulmonary vascular permeability and always high in ARDS (acute respiratory distress syndrome)
15 secondary outcomes
Autophagy biomarkers in exosomes: LC3II (Western blots)
Time frame: 6 hours
Autophagy biomarkers in exosomes: LC3II (NTA)
Time frame: 6 hours
Autophagy modifiers in exosomes: mTOR (Western blots)
Time frame: 6 hours
Autophagy modifiers in exosomes: mTOR (NTA)
Time frame: 6 hours
Autophagy modifiers in exosomes: HSP70 (Western blots)
Time frame: 6 hours
Autophagy modifiers in exosomes: HSP70 (NTA)
Time frame: 6 hours
Autophagy modifiers in exosomes: sequestosome 1 (Western blots)
Time frame: 6 hours
Autophagy modifiers in exosomes: sequestosome 1 (NTA)
Time frame: 6 hours
Exosomes marker: CD9 (Western blots)
Time frame: 6 hours
Exosomes marker: CD9 (NTA)
Time frame: 6 hours
ICU mortality
Time frame: Up to 30 days
28-day mortality
Time frame: Up to 28 days
Hospital mortality
Time frame: Up to 90 days
Length of stay in ICU
Time frame: Up to 30 days
Length of stay in hospital
Time frame: Up top 90 days
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 10 Feb 2021.
- Background: PubMed 22968077Lo S, Yuan SS, Hsu C, Cheng YJ, Chang YF, Hsueh HW, Lee PH, Hsieh YC. Lc3 over-expression improves survival and attenuates lung injury through increasing autophagosomal clearance in septic mice. Ann Surg. 2013 Feb;257(2):352-63. doi: 10.1097/SLA.0b013e318269d0e2.
- Background: PubMed 23359590Gao M, Ha T, Zhang X, Wang X, Liu L, Kalbfleisch J, Singh K, Williams D, Li C. The Toll-like receptor 9 ligand, CpG oligodeoxynucleotide, attenuates cardiac dysfunction in polymicrobial sepsis, involving activation of both phosphoinositide 3 kinase/Akt and extracellular-signal-related kinase signaling. J Infect Dis. 2013 May 1;207(9):1471-9. doi: 10.1093/infdis/jit036. Epub 2013 Jan 28.
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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.
Wen-Lin Su, PhD study director
Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Taipei Tzu Chi Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemodynamic Instability and Autophagy, run by Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation at 1 site in Taiwan.
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 3 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 10 Feb 2021. 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 Taiwan. 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?
Change of hemodynamic parameters (heart contractility: CFI) (time frame: Baseline, 6 hours). The study lists 6 primary outcomes in all. 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 NCT03267160, which also lists 2 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 10 Feb 2021.