Shock, SepticMitoSepsisNCT01600989
Mitochondrial Function of Immune Cells in Sepsis
An observational study of Shock, Septic, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
Introduction: Evidence suggests that sepsis and septic shock severely impair mitochondria and that the resulting mitochondrial dysfunction is related to the severity and outcome of the resulting organ dysfunction. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Shock, Septic
- What is being tested?
- blood sampling
- How many people
- 60 participants
- Where
- 1 siteSwitzerland
- Study dates
- May 2012to Nov 2013
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 30 patients with severe sepsis or septic shock at ICU admission
Who may be able to join
- Adult patients (age > 18years)
- Severe sepsis or septic shock as defined by the 2001 SCCM/ESICM/ACCP/ATS/SIS International Sepsis Definitions Conference guidelines at the time of admission to ICU.
Who cannot join
- Patients with any type of chronic infectious, inflammatory or autoimmune diseases
- Patients after hematopoietic or solid organ transplantation
- Patients receiving long term treatment with steroids or other immunosuppressive agents
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Intensive Care Medicine, Bern University Hospital (Inselspital) and University of Bern
Bern, 3010
About this study
Official title: Mitochondrial Function of Immune Cells in Severe Sepsis and Septic Shock - a Prospective Observational Cohort Study
Introduction: Evidence suggests that sepsis and septic shock severely impair mitochondria and that the resulting mitochondrial dysfunction is related to the severity and outcome of the resulting organ dysfunction. In sepsis mitochondrial abnormalities - biochemical and ultrastructural - have been recognized in multiple organs, including liver, kidney, skeletal and heart muscle tissue and blood cells. Circulating immune cells play an important role in the pathophysiology of sepsis. Stimulation of the immune system alters the energy requirements of immune cells; down-regulation of immune-cell activity has been associated with prolonged sepsis and unfavourable outcome. The aim of the project is to comprehensively investigate changes in mitochondrial function of immune cells in patients with severe sepsis and septic shock. The following main hypotheses will be evaluated:
- Severe sepsis and septic shock leads to increased energy requirements of immune cells and to an increase in mitochondrial enzyme activities and energy production.
- Changes of mitochondrial function in human immune cells are associated with alterations in clinical and laboratory markers of severity of sepsis.
- Prolonged sepsis and unfavourable outcome is associated with down regulation of mitochondrial function.
Read more
Methods: A total of 30 adult patients admitted to the intensive care unit (ICU) due to severe sepsis or septic shock will be included in the study; 30 healthy volunteers serve as controls. Patients with any type of chronic infectious, inflammatory or autoimmune diseases, after transplantations or receiving immunosuppressive agents are excluded.
Collected baseline characteristics include patient demographics, diagnosis and severity of illness scores at the time of admission. Daily collected follow up data include clinical and laboratory parameters of organ dysfunction, use of vasopressors/inotropes, use of antibiotics, use of steroids and results of microbiological cultures/stains.
Negative identification and isolation of monocytes, B cells and CD4 T cells will be performed daily from ICU admission to discharge using an antibody-antigen mediated immunomagnetic cell isolation procedure that depletes all blood cells except the specific target cells. Mitochondrial function of immune cells will be assessed by measurement of mitochondrial complex activity for complexes I to IV by a standard titration protocol. Additionally, the levels of pro- and anti-inflammatory cytokines (Interleukin (IL)-1, IL-6, IL-10, TNF-α) will be assessed throughout the stay in the ICU. For comparison mitochondrial function of of monocytes, B cells and CD4 T cells and cytokine levels will be measured in a group of 10 healthy volunteers.
Analysis plan: Changes in mitochondrial function of immune cells over time compared to a healthy control group and during the course of severe sepsis and septic shock is the main outcome parameter of this study. Assessed predictors are determined by the severity of the underlying septic condition and include clinical and laboratory evidence for dysfunction of vital organ systems and changes in levels of inflammatory and anti-inflammatory cytokines.
Read the detailed description
Background
Evidence suggests that sepsis and septic shock severely impair mitochondria and that the resulting mitochondrial dysfunction is related to the severity and outcome of the resulting organ dysfunction. In sepsis mitochondrial abnormalities - biochemical and ultrastructural - have been recognized in multiple organs, including liver, kidney, skeletal and heart muscle tissue and blood cells. A systematic review on mitochondrial function assessed as oxygen consumption, state 3 and state 4 respiration, respiratory enzyme activity, or tissue ATP levels and turnover rates showed decreased function especially in sepsis models lasting more than 16h . Depleted levels of reduced glutathione, an important intra-mitochondrial antioxidant, in combination with increased generation of reactive oxygen species (ROS) and reactive nitrogen species (RNS) inhibit oxidative phosphorylation and ATP generation. This acquired intrinsic derangement in cellular energy metabolism contributes to reduced activities of mitochondrial electron transport chain enzyme complexes and impaired ATP biosynthesis and contributes to the organ dysfunction in sepsis.
Circulating immune cells play an important role in the pathophysiology of sepsis. Stimulation of the immune system alters the energy requirements of immune cells; down-regulation of immune-cell activity has been associated with prolonged sepsis. Immune cell activation mandates an increase in energy requirements, thus a reduced production of ATP due to impaired mitochondrial function may be a factor in modulating the immune response in sepsis. Alterations in mitochondrial function and energetic failure have been reported in peripheral blood mononuclear cells and seem to be associated with the modulation of the immune response to sepsis. Macrophages incubated with endotoxin/interferon-γ show a decrease in oxygen consumption and inhibition of mitochondrial I complex. Different mechanisms for alteration of mitochondrial function in these cells have been proposed, including increases in NO production and nitration of mitochondrial proteins [14], elevation of IL-10 [15] or prostaglandin levels. In human neutrophils intact mitochondrial function plays an important role in chemotaxis and phagocytosis, impairment of these mechanisms leads to a decreased defence ability to microbial challenges.
HIF-1α is a transcription factor that acts as a key regulatory factor in the evolution of oxygen homeostasis. Under normoxic conditions HIF-1α is continuously synthesized and degraded after hydroxylation by dioxygenases that utilize oxygen, Fe and α-ketoglutarate as substrates. During hypoxia, the low availability of oxygen limits the reaction; HIF-1α is no longer degraded and rapidly accumulates and triggers the transcription of genes involved in oxygen homeostasis such as glycolytic enzymes, glucose transporters, vascular endothelial growth factor (VEGF) and erythropoietin. Under hypoxic conditions, HIF mediates also a decrease in mRNA levels of the respiratory chain proteins, preparing the cell to produce ATP mainly from glycolysis and not from oxidative phosphorylation, thereby optimizing cell energetics and homeostasis for survival and function during hypoxia.
Recent published reports have linked inflammation and endotoxin stimulation to HIF-1α activation. HIF-1α has been shown to be up-regulated and stabilized in LPS-treated macrophages and monocytes under normoxic conditions. HIF-1α levels were shown to be decreased in macrophages deficient in TLR4 after LPS stimulation, suggesting that LPS stimulation of HIF-1α is mediated by TLR4.
Data on mitochondrial function of human immune cells in severe sepsis is limited and the potential correlation of mitochondrial energy requirements and production and the severity of the patient's condition and outcome are not well established. The immunologic reaction in the context of severe sepsis and septic shock consists of an interdependent, highly complex system that involves different types of immune cells and pro- and anti-inflammatory cytokines involved in a time-dependent process. Simple in-vitro studies assessing mitochondrial function of a single type of immune cells and single cytokines just a one point in time during the course of the septic process might not be an appropriate model to mirror the complex interactions of the immune system. Serial measurements of mitochondrial function of different key-player cells and specific pro- and anti-inflammatory cytokines and apoptosis markers parallel with other clinical and laboratory markers of sepsis may offer a more in-depth evaluation and understanding of this deleterious disease pattern.
Objective
The aim of the project is to comprehensively investigate changes in mitochondrial function and morphology of immune cells in patients with severe sepsis and septic shock. We plan to assess changes in mitochondrial function of monocytes, B cells and CD4+ T cells in correlation to levels of various cytokines and to classic clinical and laboratory parameters of severity of sepsis and outcome.
Methods
A total of 30 patients admitted to the intensive care unit (ICU) of a tertiary care hospital due to severe sepsis or septic shock will be included in the study after obtaining written informed consent of the patient or the patient's next of kin. Patients with any type of chronic infectious, inflammatory or autoimmune diseases, after transplantations or receiving immunosuppressive agents are excluded.
Controls: 30 healthy volunteers Assessment of mitochondrial function of monocytes/granulocytes will be performed by measurement of mitochondrial complex activity using a standard titration protocol to measure activation of complex I to IV. To measure serum levels of IL-1, IL-6, IL-10 and TNF standard commercial kits will be used.
- Conditions
- Shock, Septic
- Being tested
- blood sampling
- Keywords
- shock septic, monocytes, lymphocytes, mitochondria, interleukins, Tumor Necrosis Factor-alpha, Hypoxia-Inducible Factor 1, alpha Subunit
- Medical subject headings
- Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood samplingOther
Blood samples will be taken at ICU admission, and 24h and 48h after admission, and at time of resolution of sepsis
blood samplingOther
Blood samples will be taken twice at a 7 day interval
| Study group | Role | What they receive |
|---|---|---|
| Patients with severe sepsis / septic shock | 30 Adult patients (age > 18years), with severe sepsis or septic shock as defined by the 2001 SCCM/ESICM/ACCP/ATS/SIS International Sepsis Definitions Conference guidelines at the time of admission to ICU. Receives: Other: blood sampling | |
| Healthy volunteers | Healthy volunteers Receives: Other: blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mitochondrial function of immune cells
Measured: At the time of ICU admission
Secondary outcomes (5)
Change from baseline in mitochondrial function of immune cells
Measured: 24 hours after ICU admission
Change from baseline in mitochondrial function of immune cells
Measured: 48 hours after ICU admission
Change from baseline in mitochondrial function of immune cells
Measured: At time of resoltion of sepsis, expected to be after 5 days
Levels of cytokines (of IL-1, IL-6, IL-10 and TNFa)
Measured: At ICU admission, 24h and 48h after admission, & at time of resolution of sepsis (expected to be after 5 days)
ICU mortality
Measured: At time of dismissal from ICU, expected to be after 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2012 (estimated)
- Study startMay 2012
- Primary completionOct 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shock, SepticStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tobias Merz, Study chair, Department of Intensive Care Medicine, Bern University Hospital (Inselspital) and University of Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01600989
- Sponsor's protocol ID
- 015/10
- Acronym
- MitoSepsis
- Status last verified
- Apr 2014
- First submitted
- 11 May 2012
- Last updated
- 25 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mitochondrial Function of Immune Cells in Severe Sepsis and Septic Shock - a Prospective Observational Cohort Study
- ClinicalTrials.gov ID
- NCT01600989
- Acronym / sponsor ID
- MitoSepsis / 015/10
- Conditions
- Shock, Septic
- Keywords
- shock septic, monocytes, lymphocytes, mitochondria, interleukins, Tumor Necrosis Factor-alpha, Hypoxia-Inducible Factor 1, alpha Subunit
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Oct 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 17 May 2012 (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.
Introduction: Evidence suggests that sepsis and septic shock severely impair mitochondria and that the resulting mitochondrial dysfunction is related to the severity and outcome of the resulting organ dysfunction. In sepsis mitochondrial abnormalities - biochemical and ultrastructural - have been recognized in multiple organs, including liver, kidney, skeletal and heart muscle tissue and blood cells. Circulating immune cells play an important role in the pathophysiology of sepsis. Stimulation of the immune system alters the energy requirements of immune cells; down-regulation of immune-cell activity has been associated with prolonged sepsis and unfavourable outcome. The aim of the project is to comprehensively investigate changes in mitochondrial function of immune cells in patients with severe sepsis and septic shock. The following main hypotheses will be evaluated:
- Severe sepsis and septic shock leads to increased energy requirements of immune cells and to an increase in mitochondrial enzyme activities and energy production.
- Changes of mitochondrial function in human immune cells are associated with alterations in clinical and laboratory markers of severity of sepsis.
- Prolonged sepsis and unfavourable outcome is associated with down regulation of mitochondrial function.
Methods: A total of 30 adult patients admitted to the intensive care unit (ICU) due to severe sepsis or septic shock will be included in the study; 30 healthy volunteers serve as controls. Patients with any type of chronic infectious, inflammatory or autoimmune diseases, after transplantations or receiving immunosuppressive agents are excluded.
Collected baseline characteristics include patient demographics, diagnosis and severity of illness scores at the time of admission. Daily collected follow up data include clinical and laboratory parameters of organ dysfunction, use of vasopressors/inotropes, use of antibiotics, use of steroids and results of microbiological cultures/stains.
Negative identification and isolation of monocytes, B cells and CD4 T cells will be performed daily from ICU admission to discharge using an antibody-antigen mediated immunomagnetic cell isolation procedure that depletes all blood cells except the specific target cells. Mitochondrial function of immune cells will be assessed by measurement of mitochondrial complex activity for complexes I to IV by a standard titration protocol. Additionally, the levels of pro- and anti-inflammatory cytokines (Interleukin (IL)-1, IL-6, IL-10, TNF-α) will be assessed throughout the stay in the ICU. For comparison mitochondrial function of of monocytes, B cells and CD4 T cells and cytokine levels will be measured in a group of 10 healthy volunteers.
Analysis plan: Changes in mitochondrial function of immune cells over time compared to a healthy control group and during the course of severe sepsis and septic shock is the main outcome parameter of this study. Assessed predictors are determined by the severity of the underlying septic condition and include clinical and laboratory evidence for dysfunction of vital organ systems and changes in levels of inflammatory and anti-inflammatory cytokines.
Detailed description
Background
Evidence suggests that sepsis and septic shock severely impair mitochondria and that the resulting mitochondrial dysfunction is related to the severity and outcome of the resulting organ dysfunction. In sepsis mitochondrial abnormalities - biochemical and ultrastructural - have been recognized in multiple organs, including liver, kidney, skeletal and heart muscle tissue and blood cells. A systematic review on mitochondrial function assessed as oxygen consumption, state 3 and state 4 respiration, respiratory enzyme activity, or tissue ATP levels and turnover rates showed decreased function especially in sepsis models lasting more than 16h . Depleted levels of reduced glutathione, an important intra-mitochondrial antioxidant, in combination with increased generation of reactive oxygen species (ROS) and reactive nitrogen species (RNS) inhibit oxidative phosphorylation and ATP generation. This acquired intrinsic derangement in cellular energy metabolism contributes to reduced activities of mitochondrial electron transport chain enzyme complexes and impaired ATP biosynthesis and contributes to the organ dysfunction in sepsis.
Circulating immune cells play an important role in the pathophysiology of sepsis. Stimulation of the immune system alters the energy requirements of immune cells; down-regulation of immune-cell activity has been associated with prolonged sepsis. Immune cell activation mandates an increase in energy requirements, thus a reduced production of ATP due to impaired mitochondrial function may be a factor in modulating the immune response in sepsis. Alterations in mitochondrial function and energetic failure have been reported in peripheral blood mononuclear cells and seem to be associated with the modulation of the immune response to sepsis. Macrophages incubated with endotoxin/interferon-γ show a decrease in oxygen consumption and inhibition of mitochondrial I complex. Different mechanisms for alteration of mitochondrial function in these cells have been proposed, including increases in NO production and nitration of mitochondrial proteins [14], elevation of IL-10 [15] or prostaglandin levels. In human neutrophils intact mitochondrial function plays an important role in chemotaxis and phagocytosis, impairment of these mechanisms leads to a decreased defence ability to microbial challenges.
HIF-1α is a transcription factor that acts as a key regulatory factor in the evolution of oxygen homeostasis. Under normoxic conditions HIF-1α is continuously synthesized and degraded after hydroxylation by dioxygenases that utilize oxygen, Fe and α-ketoglutarate as substrates. During hypoxia, the low availability of oxygen limits the reaction; HIF-1α is no longer degraded and rapidly accumulates and triggers the transcription of genes involved in oxygen homeostasis such as glycolytic enzymes, glucose transporters, vascular endothelial growth factor (VEGF) and erythropoietin. Under hypoxic conditions, HIF mediates also a decrease in mRNA levels of the respiratory chain proteins, preparing the cell to produce ATP mainly from glycolysis and not from oxidative phosphorylation, thereby optimizing cell energetics and homeostasis for survival and function during hypoxia.
Recent published reports have linked inflammation and endotoxin stimulation to HIF-1α activation. HIF-1α has been shown to be up-regulated and stabilized in LPS-treated macrophages and monocytes under normoxic conditions. HIF-1α levels were shown to be decreased in macrophages deficient in TLR4 after LPS stimulation, suggesting that LPS stimulation of HIF-1α is mediated by TLR4.
Data on mitochondrial function of human immune cells in severe sepsis is limited and the potential correlation of mitochondrial energy requirements and production and the severity of the patient's condition and outcome are not well established. The immunologic reaction in the context of severe sepsis and septic shock consists of an interdependent, highly complex system that involves different types of immune cells and pro- and anti-inflammatory cytokines involved in a time-dependent process. Simple in-vitro studies assessing mitochondrial function of a single type of immune cells and single cytokines just a one point in time during the course of the septic process might not be an appropriate model to mirror the complex interactions of the immune system. Serial measurements of mitochondrial function of different key-player cells and specific pro- and anti-inflammatory cytokines and apoptosis markers parallel with other clinical and laboratory markers of sepsis may offer a more in-depth evaluation and understanding of this deleterious disease pattern.
Objective
The aim of the project is to comprehensively investigate changes in mitochondrial function and morphology of immune cells in patients with severe sepsis and septic shock. We plan to assess changes in mitochondrial function of monocytes, B cells and CD4+ T cells in correlation to levels of various cytokines and to classic clinical and laboratory parameters of severity of sepsis and outcome.
Methods
A total of 30 patients admitted to the intensive care unit (ICU) of a tertiary care hospital due to severe sepsis or septic shock will be included in the study after obtaining written informed consent of the patient or the patient's next of kin. Patients with any type of chronic infectious, inflammatory or autoimmune diseases, after transplantations or receiving immunosuppressive agents are excluded.
Controls: 30 healthy volunteers Assessment of mitochondrial function of monocytes/granulocytes will be performed by measurement of mitochondrial complex activity using a standard titration protocol to measure activation of complex I to IV. To measure serum levels of IL-1, IL-6, IL-10 and TNF standard commercial kits will be used.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with severe sepsis / septic shock | – | Other: blood sampling30 Adult patients (age > 18years), with severe sepsis or septic shock as defined by the 2001 SCCM/ESICM/ACCP/ATS/SIS International Sepsis Definitions Conference guidelines at the time of admission to ICU. |
| Healthy volunteers | – | Other: blood samplingHealthy volunteers |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 30 patients with severe sepsis or septic shock at ICU admission
Key inclusion criteria (2 listed)
- Adult patients (age > 18years)
- Severe sepsis or septic shock as defined by the 2001 SCCM/ESICM/ACCP/ATS/SIS International Sepsis Definitions Conference guidelines at the time of admission to ICU.
Key exclusion criteria (3 listed)
- Patients with any type of chronic infectious, inflammatory or autoimmune diseases
- Patients after hematopoietic or solid organ transplantation
- Patients receiving long term treatment with steroids or other immunosuppressive agents
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 |
|---|---|---|
| blood samplingBlood samples will be taken at ICU admission, and 24h and 48h after admission, and at time of resolution of sepsis | Other | Patients with severe sepsis / septic shock |
| blood samplingBlood samples will be taken twice at a 7 day interval | Other | Healthy volunteers |
Primary outcome
Mitochondrial function of immune cells
Time frame: At the time of ICU admission
5 secondary outcomes
Change from baseline in mitochondrial function of immune cells
Time frame: 24 hours after ICU admission
Change from baseline in mitochondrial function of immune cells
Time frame: 48 hours after ICU admission
Change from baseline in mitochondrial function of immune cells
Time frame: At time of resoltion of sepsis, expected to be after 5 days
Levels of cytokines (of IL-1, IL-6, IL-10 and TNFa)
Time frame: At ICU admission, 24h and 48h after admission, & at time of resolution of sepsis (expected to be after 5 days)
ICU mortality
Time frame: At time of dismissal from ICU, expected to be after 7 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 25 Apr 2014.
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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.
Tobias Merz study chair
Department of Intensive Care Medicine, Bern University Hospital (Inselspital) and University of Bern
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 Shock, Septic, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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 2 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 25 Apr 2014. 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 Switzerland. 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?
Mitochondrial function of immune cells (time frame: At the time of ICU admission). 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 25 Apr 2014.