Out-of-Hospital Cardiac ArrestCOMACARENCT02698917

Carbon Dioxide, Oxygen and Mean Arterial Pressure After Cardiac Arrest and Resuscitation

A study testing Low normal PaCO2, High normal PaCO2 and Low normal PaO2 in people with Out-of-Hospital Cardiac Arrest, run by Helsinki University Central Hospital at 7 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Out-of-Hospital Cardiac Arrest
What is being tested?: Low normal PaCO2, High normal PaCO2 and Low normal PaO2
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 123 participants
Where: 7 sitesin 2 countries
Study dates: 22 Mar 2016to 3 May 2018
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 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Witnessed out-of-hospital cardiac arrest with ventricular fibrillation (VF) or ventricular tachycardia (VT) as the initial rhythm
Delay of return of spontaneous circulation (ROSC) 10-45 min from the start of the arrest
Confirmed or suspected cardiac origin
Mechanical ventilation
Markedly impaired level of consciousness (no response to verbal commands and Glasgow coma scale [GCS] motor score < 5)
Deferred consent possible or likely
Active intensive care initiated, including targeted temperature management (33-36 C)

Who cannot join

Probable withdrawal of active ICU care due to terminal illness or poor prognosis because of severely reduced functional status before cardiac arrest
Confirmed or suspected intracranial pathology and/or suspicion of raised intracranial pressure
Pregnancy
Severe oxygenation problem (PaO2 / FiO2 < 100 mmHg)
Severe COPD

Trial locations and contacts

7 sites in 2 countries.

Country

City, postcode or hospital

7 sites in 2 countries

Finland6 sites

Helsinki University Hospital
Helsinki
North Karelia Central Hospital
Joensuu
Central Finland Central Hospital
Jyväskylä
Kuopio University Hospital
Kuopio
Päijät-Häme Central Hospital
Lahti
Tampere University Hospital
Tampere

Other trials in Finland

Denmark1 site

Aarhus University Hospital
Aarhus

Other trials in Denmark

About this study

Official title: Carbon Dioxide, Oxygen and Mean Arterial Pressure After Cardiac Arrest and Resuscitation - Targeting High vs. Low Normal Values

The COMACARE trial is a pilot multicenter randomized trial to assess the feasibility and effect on brain injury markers of targeting low or high normal arterial oxygen tension (PaO2), arterial carbon dioxide tension (PaCO2) and mean arterial pressure (MAP) in comatose, mechanically ventilated patients after out-of-hospital cardiac arrest. Using factorial design, participants are randomized at admission to intensive care unit to one of eight groups targeting either low or high normal values of PaO2, PaCO2 and MAP for 36 h. In this way, investigators will be assessing the feasibility and effect of all three variables at the same time.

The primary outcome is serum concentration of neuron-specific enolase (NSE) at 48 h after cardiac arrest. Feasibility outcome is between-group separation in PaO2, PaCO2 and MAP levels. Secondary outcomes include continuous monitoring of cerebral oxygenation, EEG and ECG for 48 h, the levels of NSE, S100B and cardiac troponin at randomization and 24, 48 and 72 h after cardiac arrest and neurological assessment at 6 months after cardiac arrest.

Conditions: Out-of-Hospital Cardiac Arrest
Being tested: Low normal PaCO2, High normal PaCO2, Low normal PaO2, High normal PaO2, Low normal MAP
Keywords: Out-of-Hospital Cardiac Arrest, Resuscitation, Hypoxia-Ischemia, Brain
Medical subject headings: Out-of-Hospital Cardiac Arrest, Hypoxia-Ischemia, Brain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Low normal PaCO2Other
4.5-4.7 kPa
High normal PaCO2Other
5.8-6.0 kPa
Low normal PaO2Other
10-15 kPa
High normal PaO2Other
20-25 kPa
Low normal MAPOther
65-75 mmHg
High normal MAPOther
80-100 mmHg

Study groups in NCT02698917
Study group	Role	What they receive
Group 1	Active comparator	Low normal PaCO2, low normal PaO2, low normal MAP Receives: Other: Low normal PaCO2; Other: Low normal PaO2; Other: Low normal MAP
Group 2	Active comparator	High normal PaCO2, low normal PaO2, low normal MAP Receives: Other: High normal PaCO2; Other: Low normal PaO2; Other: Low normal MAP
Group 3	Active comparator	Low normal PaCO2, high normal PaO2, low normal MAP Receives: Other: Low normal PaCO2; Other: High normal PaO2; Other: Low normal MAP
Group 4	Active comparator	High normal PaCO2, high normal PaO2, low normal MAP Receives: Other: High normal PaCO2; Other: High normal PaO2; Other: Low normal MAP
Group 5	Active comparator	Low normal PaCO2, low normal PaO2, high normal MAP Receives: Other: Low normal PaCO2; Other: Low normal PaO2; Other: High normal MAP
Group 6	Active comparator	High normal PaCO2, low normal PaO2, high normal MAP Receives: Other: High normal PaCO2; Other: Low normal PaO2; Other: High normal MAP
Group 7	Active comparator	Low normal PaCO2, high normal PaO2, high normal MAP Receives: Other: Low normal PaCO2; Other: High normal PaO2; Other: High normal MAP
Group 8	Active comparator	High normal PaCO2, high normal PaO2, high normal MAP Receives: Other: High normal PaCO2; Other: High normal PaO2; Other: High normal MAP

What is being measured

The primary outcome is the main question the study is designed to answer.

Neuron-specific enolase (NSE) serum concentration
Measured: 48 hour after cardiac arrest

Secondary outcomes (6)

Neuron-specific enolase (NSE) serum concentration
Measured: At randomization and 24 and 72 hour after cardiac arrest
S100B protein serum concentration
Measured: At randomization and 24, 48 and 72 hour after cardiac arrest
Cardiac troponin (TnT) serum concentration
Measured: At randomization and 24, 48 and 72 hour after cardiac arrest
Cerebral oxygenation monitoring using near infrared spectroscopy (NIRS) monitoring
Measured: For 48 hour after admission to ICU
Continuous electroencephalography (EEG) monitoring
Measured: For 48 hour after admission to ICU
Functional status using cerebral performance category (CPC) classification
Measured: At 30 days and 6 months after cardiac arrest

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Mar 20163 May 2018

First posted4 Mar 2016 (estimated)
Study start22 Mar 2016
Primary completion3 Nov 2017
Study completion3 May 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (7)Papers the sponsor has linked to this study.
Other trials for Out-of-Hospital Cardiac ArrestStudies of the same condition, open and under way.
More trials run by Helsinki University Central HospitalThe 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: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 123 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02698917
Sponsor's protocol ID: 15/2015
Acronym: COMACARE
Status last verified: Aug 2018
First submitted: 26 Jan 2016
Last updated: 3 Aug 2018
Results posted: No
Data monitoring committee: No

Publications

Laurikkala J, Ameloot K, Reinikainen M, Palmers PJ, De Deyne C, Bert F, Dupont M, Janssens S, Dens J, Hastbacka J, Jakkula P, Loisa P, Birkelund T, Wilkman E, Vaara ST, Skrifvars MB. The effect of higher or lower mean arterial pressure on kidney function after cardiac arrest: a post hoc analysis of the COMACARE and NEUROPROTECT trials. Ann Intensive Care. 2023 Nov 21;13(1):113. doi: 10.1186/s13613-023-01210-0.
PubMed 37987871
Humaloja J, Lahde M, Ashton NJ, Reinikainen M, Hastbacka J, Jakkula P, Friberg H, Cronberg T, Pettila V, Blennow K, Zetterberg H, Skrifvars MB; COMACARE Study Groups. GFAp and tau protein as predictors of neurological outcome after out-of-hospital cardiac arrest: A post hoc analysis of the COMACARE trial. Resuscitation. 2022 Jan;170:141-149. doi: 10.1016/j.resuscitation.2021.11.033. Epub 2021 Dec 1.
PubMed 34863908
Laurikkala J, Aneman A, Peng A, Reinikainen M, Pham P, Jakkula P, Hastbacka J, Wilkman E, Loisa P, Toppila J, Birkelund T, Blennow K, Zetterberg H, Skrifvars MB. Association of deranged cerebrovascular reactivity with brain injury following cardiac arrest: a post-hoc analysis of the COMACARE trial. Crit Care. 2021 Sep 28;25(1):350. doi: 10.1186/s13054-021-03764-6.
PubMed 34583763
Ameloot K, Jakkula P, Hastbacka J, Reinikainen M, Pettila V, Loisa P, Tiainen M, Bendel S, Birkelund T, Belmans A, Palmers PJ, Bogaerts E, Lemmens R, De Deyne C, Ferdinande B, Dupont M, Janssens S, Dens J, Skrifvars MB. Optimum Blood Pressure in Patients With Shock After Acute Myocardial Infarction and Cardiac Arrest. J Am Coll Cardiol. 2020 Aug 18;76(7):812-824. doi: 10.1016/j.jacc.2020.06.043.
PubMed 32792079
Jakkula P, Hastbacka J, Reinikainen M, Pettila V, Loisa P, Tiainen M, Wilkman E, Bendel S, Birkelund T, Pulkkinen A, Backlund M, Heino S, Karlsson S, Kopponen H, Skrifvars MB. Near-infrared spectroscopy after out-of-hospital cardiac arrest. Crit Care. 2019 May 14;23(1):171. doi: 10.1186/s13054-019-2428-3.
PubMed 31088512
Jakkula P, Reinikainen M, Hastbacka J, Loisa P, Tiainen M, Pettila V, Toppila J, Lahde M, Backlund M, Okkonen M, Bendel S, Birkelund T, Pulkkinen A, Heinonen J, Tikka T, Skrifvars MB; COMACARE study group. Targeting two different levels of both arterial carbon dioxide and arterial oxygen after cardiac arrest and resuscitation: a randomised pilot trial. Intensive Care Med. 2018 Dec;44(12):2112-2121. doi: 10.1007/s00134-018-5453-9. Epub 2018 Nov 14.
PubMed 30430209
Jakkula P, Reinikainen M, Hastbacka J, Pettila V, Loisa P, Karlsson S, Laru-Sompa R, Bendel S, Oksanen T, Birkelund T, Tiainen M, Toppila J, Hakkarainen A, Skrifvars MB; COMACARE study group. Targeting low- or high-normal Carbon dioxide, Oxygen, and Mean arterial pressure After Cardiac Arrest and REsuscitation: study protocol for a randomized pilot trial. Trials. 2017 Oct 30;18(1):507. doi: 10.1186/s13063-017-2257-0.
PubMed 29084585

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Execution of Prehospital Transesophageal Echocardiography During Cardiopulmonary Resuscitation in Patients With Out-of-hospital Cardiac Arrest
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The REVIVE-PEEP Trial: Positive End-expiratory Pressure Versus Sham Valve/Zero End-expiratory Pressure in Cardiopulmonary Resuscitation During Manual Ventilation to Improve Neurological Outcomes at Discharge in Adult Patients Suffering an Out-of-hospital Cardiac Arrest
Cardiac Arrest, Out-Of-Hospital
Active, not recruiting
RACE-CARS - RAndomized Cluster Evaluation of Cardiac ARrest Systems
Cardiac Arrest

All Out-of-Hospital Cardiac Arrest trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Carbon Dioxide, Oxygen and Mean Arterial Pressure After Cardiac Arrest and Resuscitation - Targeting High vs. Low Normal Values
ClinicalTrials.gov ID: NCT02698917
Acronym / sponsor ID: COMACARE / 15/2015
Conditions: Out-of-Hospital Cardiac Arrest
Keywords: Out-of-Hospital Cardiac Arrest, Resuscitation, Hypoxia-Ischemia, Brain
Study type: Interventional
Recruitment status: Completed
Enrolment: 123 participants (actual)
Lead sponsor: Helsinki University Central HospitalUniversity, hospital or other
Collaborators: Laerdal Foundation, The Finnish Medical Association, Orion Research Foundation, Finnish Society of Anaesthesiologists
Study start: 22 Mar 2016 (actual)
Primary completion: 3 Nov 2017 (actual)
Study completion: 3 May 2018 (actual)
First posted: 4 Mar 2016 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: Single blind (outcomes assessor)
Number of arms: 8

Arm	Type	Receives
Group 1	Active comparator	Other: Low normal PaCO2, Other: Low normal PaO2, Other: Low normal MAPLow normal PaCO2, low normal PaO2, low normal MAP
Group 2	Active comparator	Other: High normal PaCO2, Other: Low normal PaO2, Other: Low normal MAPHigh normal PaCO2, low normal PaO2, low normal MAP
Group 3	Active comparator	Other: Low normal PaCO2, Other: High normal PaO2, Other: Low normal MAPLow normal PaCO2, high normal PaO2, low normal MAP
Group 4	Active comparator	Other: High normal PaCO2, Other: High normal PaO2, Other: Low normal MAPHigh normal PaCO2, high normal PaO2, low normal MAP
Group 5	Active comparator	Other: Low normal PaCO2, Other: Low normal PaO2, Other: High normal MAPLow normal PaCO2, low normal PaO2, high normal MAP
Group 6	Active comparator	Other: High normal PaCO2, Other: Low normal PaO2, Other: High normal MAPHigh normal PaCO2, low normal PaO2, high normal MAP
Group 7	Active comparator	Other: Low normal PaCO2, Other: High normal PaO2, Other: High normal MAPLow normal PaCO2, high normal PaO2, high normal MAP
Group 8	Active comparator	Other: High normal PaCO2, Other: High normal PaO2, Other: High normal MAPHigh normal PaCO2, high normal PaO2, high normal MAP

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Witnessed out-of-hospital cardiac arrest with ventricular fibrillation (VF) or ventricular tachycardia (VT) as the initial rhythm
Delay of return of spontaneous circulation (ROSC) 10-45 min from the start of the arrest
Confirmed or suspected cardiac origin
Mechanical ventilation
Markedly impaired level of consciousness (no response to verbal commands and Glasgow coma scale [GCS] motor score < 5)

Key exclusion criteria (5 listed)

Probable withdrawal of active ICU care due to terminal illness or poor prognosis because of severely reduced functional status before cardiac arrest
Confirmed or suspected intracranial pathology and/or suspicion of raised intracranial pressure
Pregnancy
Severe oxygenation problem (PaO2 / FiO2 < 100 mmHg)
Severe COPD

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 normal PaCO24.5-4.7 kPa	Other	Group 1, Group 3, Group 5, Group 7
High normal PaCO25.8-6.0 kPa	Other	Group 2, Group 4, Group 6, Group 8
Low normal PaO210-15 kPa	Other	Group 1, Group 2, Group 5, Group 6
High normal PaO220-25 kPa	Other	Group 3, Group 4, Group 7, Group 8
Low normal MAP65-75 mmHg	Other	Group 1, Group 2, Group 3, Group 4
High normal MAP80-100 mmHg	Other	Group 5, Group 6, Group 7, Group 8

Primary outcome

Neuron-specific enolase (NSE) serum concentration
Time frame: 48 hour after cardiac arrest

6 secondary outcomes

Neuron-specific enolase (NSE) serum concentration
Time frame: At randomization and 24 and 72 hour after cardiac arrest
S100B protein serum concentration
Time frame: At randomization and 24, 48 and 72 hour after cardiac arrest
Cardiac troponin (TnT) serum concentration
Time frame: At randomization and 24, 48 and 72 hour after cardiac arrest
Cerebral oxygenation monitoring using near infrared spectroscopy (NIRS) monitoring
Time frame: For 48 hour after admission to ICU
Continuous electroencephalography (EEG) monitoring
Time frame: For 48 hour after admission to ICU
Functional status using cerebral performance category (CPC) classification
Time frame: At 30 days and 6 months after cardiac arrest

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 3 Aug 2018.
Derived from this study: PubMed 37987871Laurikkala J, Ameloot K, Reinikainen M, Palmers PJ, De Deyne C, Bert F, Dupont M, Janssens S, Dens J, Hastbacka J, Jakkula P, Loisa P, Birkelund T, Wilkman E, Vaara ST, Skrifvars MB. The effect of higher or lower mean arterial pressure on kidney function after cardiac arrest: a post hoc analysis of the COMACARE and NEUROPROTECT trials. Ann Intensive Care. 2023 Nov 21;13(1):113. doi: 10.1186/s13613-023-01210-0.
Derived from this study: PubMed 34863908Humaloja J, Lahde M, Ashton NJ, Reinikainen M, Hastbacka J, Jakkula P, Friberg H, Cronberg T, Pettila V, Blennow K, Zetterberg H, Skrifvars MB; COMACARE Study Groups. GFAp and tau protein as predictors of neurological outcome after out-of-hospital cardiac arrest: A post hoc analysis of the COMACARE trial. Resuscitation. 2022 Jan;170:141-149. doi: 10.1016/j.resuscitation.2021.11.033. Epub 2021 Dec 1.
Derived from this study: PubMed 34583763Laurikkala J, Aneman A, Peng A, Reinikainen M, Pham P, Jakkula P, Hastbacka J, Wilkman E, Loisa P, Toppila J, Birkelund T, Blennow K, Zetterberg H, Skrifvars MB. Association of deranged cerebrovascular reactivity with brain injury following cardiac arrest: a post-hoc analysis of the COMACARE trial. Crit Care. 2021 Sep 28;25(1):350. doi: 10.1186/s13054-021-03764-6.
Derived from this study: PubMed 32792079Ameloot K, Jakkula P, Hastbacka J, Reinikainen M, Pettila V, Loisa P, Tiainen M, Bendel S, Birkelund T, Belmans A, Palmers PJ, Bogaerts E, Lemmens R, De Deyne C, Ferdinande B, Dupont M, Janssens S, Dens J, Skrifvars MB. Optimum Blood Pressure in Patients With Shock After Acute Myocardial Infarction and Cardiac Arrest. J Am Coll Cardiol. 2020 Aug 18;76(7):812-824. doi: 10.1016/j.jacc.2020.06.043.
Derived from this study: PubMed 31088512Jakkula P, Hastbacka J, Reinikainen M, Pettila V, Loisa P, Tiainen M, Wilkman E, Bendel S, Birkelund T, Pulkkinen A, Backlund M, Heino S, Karlsson S, Kopponen H, Skrifvars MB. Near-infrared spectroscopy after out-of-hospital cardiac arrest. Crit Care. 2019 May 14;23(1):171. doi: 10.1186/s13054-019-2428-3.
Derived from this study: PubMed 30430209Jakkula P, Reinikainen M, Hastbacka J, Loisa P, Tiainen M, Pettila V, Toppila J, Lahde M, Backlund M, Okkonen M, Bendel S, Birkelund T, Pulkkinen A, Heinonen J, Tikka T, Skrifvars MB; COMACARE study group. Targeting two different levels of both arterial carbon dioxide and arterial oxygen after cardiac arrest and resuscitation: a randomised pilot trial. Intensive Care Med. 2018 Dec;44(12):2112-2121. doi: 10.1007/s00134-018-5453-9. Epub 2018 Nov 14.
Derived from this study: PubMed 29084585Jakkula P, Reinikainen M, Hastbacka J, Pettila V, Loisa P, Karlsson S, Laru-Sompa R, Bendel S, Oksanen T, Birkelund T, Tiainen M, Toppila J, Hakkarainen A, Skrifvars MB; COMACARE study group. Targeting low- or high-normal Carbon dioxide, Oxygen, and Mean arterial pressure After Cardiac Arrest and REsuscitation: study protocol for a randomized pilot trial. Trials. 2017 Oct 30;18(1):507. doi: 10.1186/s13063-017-2257-0.

Related trials for Out-of-Hospital Cardiac Arrest

Active, not recruitingPhase 3
The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
Not yet recruiting
Compression-Only Versus Standard Basic Life Support Training in Nursing Students
Cardiopulmonary Resuscitation, Out-of-Hospital Cardiac Arrest
Not yet recruiting
Execution of Prehospital Transesophageal Echocardiography During Cardiopulmonary Resuscitation in Patients With Out-of-hospital Cardiac Arrest
Out-of-hospital Cardiac Arrest (OHCA)
Active, not recruiting
The REVIVE-PEEP Trial: Positive End-expiratory Pressure Versus Sham Valve/Zero End-expiratory Pressure in Cardiopulmonary Resuscitation During Manual Ventilation to Improve Neurological Outcomes at Discharge in Adult Patients Suffering an Out-of-hospital Cardiac Arrest
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Active, not recruiting
RACE-CARS - RAndomized Cluster Evaluation of Cardiac ARrest Systems
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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.

Matti Reinikainen, Associate Professor study director

Kuopio University Hospital

7 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Low normal PaCO2, High normal PaCO2 and Low normal PaO2 in people with Out-of-Hospital Cardiac Arrest, run by Helsinki University Central Hospital at 7 sites in 2 countries.

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 7 inclusion and 5 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 3 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Finland, Denmark. 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?

Neuron-specific enolase (NSE) serum concentration (time frame: 48 hour after cardiac arrest). 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 NCT02698917, which also lists 7 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 3 Aug 2018; AzTrials last refreshed its copy on 8 Nov 2026.