Critical IllnessNCT05741762
Assessing Baseline Cortisol Levels in Patients Admitted With Septic Shock in Intensive Care Unit
An observational study of Critical Illness and Adrenal Insufficiency, run by Dr Adnan Agha at 1 site in United Arab Emirates.
Trial summary
Critical illness-related corticosteroid insufficiency (CIRCI), a term coined since 2008 by Society of Critical Care Medicine (SCCM), and is characterized by inflammation resulting from inadequate intracellular glucocorticoid-mediated anti-inflammatory activity leading to increased morbidity and mortality in Intensive… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Critical Illness, Adrenal Insufficiency, Septic Shock
- What is being tested?
- Retrospective chart review
- How many people
- 50 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 31 Jan 2023to Apr 2024
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study Type: Retrospective observational study in which chart review of records of all patients admitted to ICU with diagnosis of severe sepsis will be done Study location ICU, Tawam Hospital, Al Ain Study duration The retrospective chart review will be done for patient admitted into ICU between 01/06/2012 to 01/06/2022
Who may be able to join
- Age > 18; both male or female
- Any nationality
- Patients admitted to ICU with diagnosis of severe sepsis / septic shock bearing ICD-10 codes R65.20 or R65.21, AND
- who required ionotropic support within 24-48 hours of admission, AND
- had a valid cortisol measurement done during this admission/encounter
Who cannot join
- Patients with additional diagnosis of polytrauma or haemorrhagic shock or other causes of shock other than septic shock.
- Patient who received steroids within 24 hours prior to sending cortisol sample
- Patient with known adrenal insufficiency.
- Patient on oral/inhaled steroids (home medications) prior to this admission for any reason (equivalent to 7.5 mg prednisolone or above) in the last 6 weeks
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessing Baseline Cortisol Levels in Patients Admitted With Septic Shock in Intensive Care Unit; A Single Centre Real World Study.
Critical illness-related corticosteroid insufficiency (CIRCI), a term coined since 2008 by Society of Critical Care Medicine (SCCM), and is characterized by inflammation resulting from inadequate intracellular glucocorticoid-mediated anti-inflammatory activity leading to increased morbidity and mortality in Intensive Care Unit (ICU) patients.1 Severe Sepsis with shock is a common reason for admission to ICU/hospital and may require ionotropic support.2 The current guidelines from SCCM in 2017 suggest using either random cortisol of < 10 ug/dL (<276 nmol/L) or change in cortisol at 60 min after cosyntropin (250 µg) administration from baseline cortisol of <9 µg/dl (<248 nmol/L) to assess of presence of CRCI and recommend use of hydrocortisone in these patients.3 There have been studies done to look at baseline cortisol in patient with severe pneumonia requiring ICU and they have found cortisol level of < 15 ug/dl (<414 nmol/L) can predict CIRCI.4 However, there is no study on assessment of baseline random cortisol levels in patients with septic shock in our local population. The current guidance from Surviving Sepsis campaign suggests a more clinical approach of adding IV corticosteroids only if there is ongoing requirement for vasopressors, which is a new change in contrast to 2016 guidelines.5
This study aims to look the available mean baseline cortisol in these patients to create a reference data for local population.
Read the detailed description
This is the first study to ascertain the baseline cortisol in patients with septic shock in local Emirati population. This will help provide more evidence towards diagnosing/ruling out CIRCI reliably. At present there is no consensus data globally on expected random cortisol levels in patients having septic shock and no data expected random cortisol levels in UAE/Gulf region in these patients which makes diagnosis of CIRCI difficult. Objective:
Primary:
The aim of this study is to estimate the mean random cortisol levels for patient admitted to ICU with septic shock requiring ionotropic support (who did not require any hydrocortisone during ICU stay) at Tawam hospital, United Arab Emirates to obtain a reference for our local population.
Secondary:
- To estimate the mean random cortisol levels for patient admitted to ICU with septic shock requiring ionotropic support (who also required hydrocortisone) during ICU stay to obtain a reference for our local population with CIRCI.
- To assess the outcome of patients treated as CIRCI.
- To assess the duration of hydrocortisone-use during ICU/hospital.
- To see if the steroids were continued post discharge from ICU/hospital.
- To compare biochemical profile of the patients treated with suspected CRICI in comparison to patients not requiring any steroids.
Study Type:
Retrospective observational study in which chart review of records of all patients admitted to ICU with diagnosis of severe sepsis will be done
Study location ICU, Tawam Hospital, Al Ain
Study duration The retrospective chart review will be done for patient admitted into ICU between 01/06/2012 to 01/06/2022
Sample Size:
Investigators plan to include minimum 400 patients based on study power calculation of minimum 386 patients.
INCLUSION CRITERIA:
- Age > 18; both male or female
- Any nationality
- Patients admitted to ICU with diagnosis of severe sepsis / septic shock bearing ICD-10 codes R65.20 or R65.21, AND
- who required ionotropic support within 24-48 hours of admission, AND
- had a valid cortisol measurement done during this admission/encounter
EXCLUSION CRITERIA:
- Patients with additional diagnosis of polytrauma or haemorrhagic shock or other causes of shock other than septic shock.
- Patient who received steroids within 24 hours prior to sending cortisol sample
- Patient with known adrenal insufficiency.
- Patient on oral/inhaled steroids (home medications) prior to this admission for any reason (equivalent to 7.5 mg prednisolone or above) in the last 6 weeks
Sample Collection Process:
This is a retrospective observational study in which records of all patients admitted to ICU with diagnosis of severe sepsis / septic shock bearing ICD-10 codes R65.20 or R65.21, who required ionotropic support within 24 hours of admission and had a valid cortisol measurement done during this admission/encounter, will be reviewed. The biochemical workup (Full blood count, liver function and renal function test), length of stay in ITU and outcome of the patient including use of steroids during hospital or discharge will be obtained.
Consenting Process:
It will an observational study (no intervention) with retrospective analysis of patient records on SalamTek. No patient sensitive or identifiable information will be kept on records. No individual patient consenting required.
Data Handling/confidentiality \& Statistical Analysis:
The data will be collected on an excel sheet in secure CMHS network with no identifiable patient information. This excel sheet will be transferred onto SPSS package for Microsoft Windows version 12.0. The variables of demography (age, sex), history of present disease (duration, severity), positive signs and routine investigations will be presented as simple descriptive statistics. The means and standard deviations of the numerical data such as age, Haemoglobin, creatinine, etc will be calculated. The mean first cortisol level (prior to any corticosteroid treatment) for patients without diagnosis of CRICI (who responded to ionotropes) will be obtained to see the baseline cortisol level in these patients. For patient treated as CIRCI, the mean cortisol level will be obtained and comparison analysis via receiver operator curves will be obtained to see if a value of random cortisol can predict absence of CIRCI with at least 95% sensitivity.
- Conditions
- Critical Illness, Adrenal Insufficiency, Septic Shock
- Being tested
- Retrospective chart review
- Medical subject headings
- Critical Illness, Adrenal Insufficiency, Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retrospective chart reviewOther
The retrospective chart review will be done for patient admitted into ICU between 01/06/2017 to 01/06/2022
What is being measured
The primary outcome is the main question the study is designed to answer.
Cortisol levels (nmol/L)
The aim of this study is to measure the mean random cortisol levels (in nmol/L) for patient admitted to ICU with septic shock requiring ionotropic support (who did not require any hydrocortisone during ICU stay) at Tawam hospital, United Arab Emirates to obtain a reference for our local population.
Measured: last 5 years
Secondary outcomes (3)
Treatment for CRICI (total hydrocortisone dosage estimation in mg/day/patient)
To measure the duration of hydrocortisone-use in terms (total dose in mg and total duration in days) given during ICU/hospital for CIRCI and see compliance in line with recent guidelines from EASD.
Measured: last 5 years
outcome of patients (mortality)
To measure the mortality (in terms of total deaths as well as duration of hospital stay in days) in patients treated as CIRCI in ICU
Measured: last 5 years
steroid on discharge requirement
To estimate the number of patients with CIRCI in ICU who were given steroids post discharge from ICU/hospital.
Measured: last 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2023
- Study start31 Jan 2023
- Primary completionFeb 2024 (estimated)
- Study completionApr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr Adnan Agha
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr Adnan Agha, United Arab Emirates University
- Investigators
- Adnan Agha, Principal investigator, United Arab Emirates University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05741762
- Sponsor's protocol ID
- UAEU_CMHS_IM_MF2058-2022-876
- Status last verified
- Jan 2024
- First submitted
- 2 Feb 2023
- Last updated
- 11 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Annane D, Pastores SM, Rochwerg B, Arlt W, Balk RA, Beishuizen A, Briegel J, Carcillo J, Christ-Crain M, Cooper MS, Marik PE, Umberto Meduri G, Olsen KM, Rodgers S, Russell JA, Van den Berghe G. Guidelines for the diagnosis and management of critical illness-related corticosteroid insufficiency (CIRCI) in critically ill patients (Part I): Society of Critical Care Medicine (SCCM) and European Society of Intensive Care Medicine (ESICM) 2017. Intensive Care Med. 2017 Dec;43(12):1751-1763. doi: 10.1007/s00134-017-4919-5. Epub 2017 Sep 21.
PubMed 28940011Marik PE, Pastores SM, Annane D, Meduri GU, Sprung CL, Arlt W, Keh D, Briegel J, Beishuizen A, Dimopoulou I, Tsagarakis S, Singer M, Chrousos GP, Zaloga G, Bokhari F, Vogeser M; American College of Critical Care Medicine. Recommendations for the diagnosis and management of corticosteroid insufficiency in critically ill adult patients: consensus statements from an international task force by the American College of Critical Care Medicine. Crit Care Med. 2008 Jun;36(6):1937-49. doi: 10.1097/CCM.0b013e31817603ba.
PubMed 18496365Evans L, Rhodes A, Alhazzani W, Antonelli M, Coopersmith CM, French C, Machado FR, Mcintyre L, Ostermann M, Prescott HC, Schorr C, Simpson S, Joost Wiersinga W, Alshamsi F, Angus DC, Arabi Y, Azevedo L, Beale R, Beilman G, Belley-Cote E, Burry L, Cecconi M, Centofanti J, Yataco AC, De Waele J, Dellinger RP, Doi K, Du B, Estenssoro E, Ferrer R, Gomersall C, Hodgson C, Moller MH, Iwashyna T, Jacob S, Kleinpell R, Klompas M, Koh Y, Kumar A, Kwizera A, Lobo S, Masur H, McGloughlin S, Mehta S, Mehta Y, Mer M, Nunnally M, Oczkowski S, Osborn T, Papathanassoglou E, Perner A, Puskarich M, Roberts J, Schweickert W, Seckel M, Sevransky J, Sprung CL, Welte T, Zimmerman J, Levy M. Executive Summary: Surviving Sepsis Campaign: International Guidelines for the Management of Sepsis and Septic Shock 2021. Crit Care Med. 2021 Nov 1;49(11):1974-1982. doi: 10.1097/CCM.0000000000005357. No abstract available.
PubMed 34643578
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Baseline Cortisol Levels in Patients Admitted With Septic Shock in Intensive Care Unit; A Single Centre Real World Study.
- ClinicalTrials.gov ID
- NCT05741762
- Acronym / sponsor ID
- UAEU_CMHS_IM_MF2058-2022-876
- Conditions
- Critical Illness, Adrenal Insufficiency, Septic Shock
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Dr Adnan AghaUniversity, hospital or other
- Study start
- 31 Jan 2023 (actual)
- Primary completion
- Feb 2024 (estimated)
- Study completion
- Apr 2024 (estimated)
- First posted
- 23 Feb 2023 (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.
Critical illness-related corticosteroid insufficiency (CIRCI), a term coined since 2008 by Society of Critical Care Medicine (SCCM), and is characterized by inflammation resulting from inadequate intracellular glucocorticoid-mediated anti-inflammatory activity leading to increased morbidity and mortality in Intensive Care Unit (ICU) patients.1 Severe Sepsis with shock is a common reason for admission to ICU/hospital and may require ionotropic support.2 The current guidelines from SCCM in 2017 suggest using either random cortisol of < 10 ug/dL (<276 nmol/L) or change in cortisol at 60 min after cosyntropin (250 µg) administration from baseline cortisol of <9 µg/dl (<248 nmol/L) to assess of presence of CRCI and recommend use of hydrocortisone in these patients.3 There have been studies done to look at baseline cortisol in patient with severe pneumonia requiring ICU and they have found cortisol level of < 15 ug/dl (<414 nmol/L) can predict CIRCI.4 However, there is no study on assessment of baseline random cortisol levels in patients with septic shock in our local population. The current guidance from Surviving Sepsis campaign suggests a more clinical approach of adding IV corticosteroids only if there is ongoing requirement for vasopressors, which is a new change in contrast to 2016 guidelines.5
This study aims to look the available mean baseline cortisol in these patients to create a reference data for local population.
Detailed description
This is the first study to ascertain the baseline cortisol in patients with septic shock in local Emirati population. This will help provide more evidence towards diagnosing/ruling out CIRCI reliably. At present there is no consensus data globally on expected random cortisol levels in patients having septic shock and no data expected random cortisol levels in UAE/Gulf region in these patients which makes diagnosis of CIRCI difficult. Objective:
Primary:
The aim of this study is to estimate the mean random cortisol levels for patient admitted to ICU with septic shock requiring ionotropic support (who did not require any hydrocortisone during ICU stay) at Tawam hospital, United Arab Emirates to obtain a reference for our local population.
Secondary:
- To estimate the mean random cortisol levels for patient admitted to ICU with septic shock requiring ionotropic support (who also required hydrocortisone) during ICU stay to obtain a reference for our local population with CIRCI.
- To assess the outcome of patients treated as CIRCI.
- To assess the duration of hydrocortisone-use during ICU/hospital.
- To see if the steroids were continued post discharge from ICU/hospital.
- To compare biochemical profile of the patients treated with suspected CRICI in comparison to patients not requiring any steroids.
Study Type:
Retrospective observational study in which chart review of records of all patients admitted to ICU with diagnosis of severe sepsis will be done
Study location ICU, Tawam Hospital, Al Ain
Study duration The retrospective chart review will be done for patient admitted into ICU between 01/06/2012 to 01/06/2022
Sample Size:
Investigators plan to include minimum 400 patients based on study power calculation of minimum 386 patients.
INCLUSION CRITERIA:
- Age > 18; both male or female
- Any nationality
- Patients admitted to ICU with diagnosis of severe sepsis / septic shock bearing ICD-10 codes R65.20 or R65.21, AND
- who required ionotropic support within 24-48 hours of admission, AND
- had a valid cortisol measurement done during this admission/encounter
EXCLUSION CRITERIA:
- Patients with additional diagnosis of polytrauma or haemorrhagic shock or other causes of shock other than septic shock.
- Patient who received steroids within 24 hours prior to sending cortisol sample
- Patient with known adrenal insufficiency.
- Patient on oral/inhaled steroids (home medications) prior to this admission for any reason (equivalent to 7.5 mg prednisolone or above) in the last 6 weeks
Sample Collection Process:
This is a retrospective observational study in which records of all patients admitted to ICU with diagnosis of severe sepsis / septic shock bearing ICD-10 codes R65.20 or R65.21, who required ionotropic support within 24 hours of admission and had a valid cortisol measurement done during this admission/encounter, will be reviewed. The biochemical workup (Full blood count, liver function and renal function test), length of stay in ITU and outcome of the patient including use of steroids during hospital or discharge will be obtained.
Consenting Process:
It will an observational study (no intervention) with retrospective analysis of patient records on SalamTek. No patient sensitive or identifiable information will be kept on records. No individual patient consenting required.
Data Handling/confidentiality \& Statistical Analysis:
The data will be collected on an excel sheet in secure CMHS network with no identifiable patient information. This excel sheet will be transferred onto SPSS package for Microsoft Windows version 12.0. The variables of demography (age, sex), history of present disease (duration, severity), positive signs and routine investigations will be presented as simple descriptive statistics. The means and standard deviations of the numerical data such as age, Haemoglobin, creatinine, etc will be calculated. The mean first cortisol level (prior to any corticosteroid treatment) for patients without diagnosis of CRICI (who responded to ionotropes) will be obtained to see the baseline cortisol level in these patients. For patient treated as CIRCI, the mean cortisol level will be obtained and comparison analysis via receiver operator curves will be obtained to see if a value of random cortisol can predict absence of CIRCI with at least 95% sensitivity.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study Type: Retrospective observational study in which chart review of records of all patients admitted to ICU with diagnosis of severe sepsis will be done Study location ICU, Tawam Hospital, Al Ain Study duration The retrospective chart review will be done for patient admitted into ICU between 01/06/2012 to 01/06/2022
Key inclusion criteria (5 listed)
- Age > 18; both male or female
- Any nationality
- Patients admitted to ICU with diagnosis of severe sepsis / septic shock bearing ICD-10 codes R65.20 or R65.21, AND
- who required ionotropic support within 24-48 hours of admission, AND
- had a valid cortisol measurement done during this admission/encounter
Key exclusion criteria (4 listed)
- Patients with additional diagnosis of polytrauma or haemorrhagic shock or other causes of shock other than septic shock.
- Patient who received steroids within 24 hours prior to sending cortisol sample
- Patient with known adrenal insufficiency.
- Patient on oral/inhaled steroids (home medications) prior to this admission for any reason (equivalent to 7.5 mg prednisolone or above) in the last 6 weeks
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 |
|---|---|---|
| Retrospective chart reviewThe retrospective chart review will be done for patient admitted into ICU between 01/06/2017 to 01/06/2022 | Other | – |
Primary outcome
Cortisol levels (nmol/L)
Time frame: last 5 years
The aim of this study is to measure the mean random cortisol levels (in nmol/L) for patient admitted to ICU with septic shock requiring ionotropic support (who did not require any hydrocortisone during ICU stay) at Tawam hospital, United Arab Emirates to obtain a reference for our local population.
3 secondary outcomes
Treatment for CRICI (total hydrocortisone dosage estimation in mg/day/patient)
Time frame: last 5 years
outcome of patients (mortality)
Time frame: last 5 years
steroid on discharge requirement
Time frame: last 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2024.
- Background: PubMed 28940011Annane D, Pastores SM, Rochwerg B, Arlt W, Balk RA, Beishuizen A, Briegel J, Carcillo J, Christ-Crain M, Cooper MS, Marik PE, Umberto Meduri G, Olsen KM, Rodgers S, Russell JA, Van den Berghe G. Guidelines for the diagnosis and management of critical illness-related corticosteroid insufficiency (CIRCI) in critically ill patients (Part I): Society of Critical Care Medicine (SCCM) and European Society of Intensive Care Medicine (ESICM) 2017. Intensive Care Med. 2017 Dec;43(12):1751-1763. doi: 10.1007/s00134-017-4919-5. Epub 2017 Sep 21.
- Background: PubMed 18496365Marik PE, Pastores SM, Annane D, Meduri GU, Sprung CL, Arlt W, Keh D, Briegel J, Beishuizen A, Dimopoulou I, Tsagarakis S, Singer M, Chrousos GP, Zaloga G, Bokhari F, Vogeser M; American College of Critical Care Medicine. Recommendations for the diagnosis and management of corticosteroid insufficiency in critically ill adult patients: consensus statements from an international task force by the American College of Critical Care Medicine. Crit Care Med. 2008 Jun;36(6):1937-49. doi: 10.1097/CCM.0b013e31817603ba.
- Background: PubMed 34643578Evans L, Rhodes A, Alhazzani W, Antonelli M, Coopersmith CM, French C, Machado FR, Mcintyre L, Ostermann M, Prescott HC, Schorr C, Simpson S, Joost Wiersinga W, Alshamsi F, Angus DC, Arabi Y, Azevedo L, Beale R, Beilman G, Belley-Cote E, Burry L, Cecconi M, Centofanti J, Yataco AC, De Waele J, Dellinger RP, Doi K, Du B, Estenssoro E, Ferrer R, Gomersall C, Hodgson C, Moller MH, Iwashyna T, Jacob S, Kleinpell R, Klompas M, Koh Y, Kumar A, Kwizera A, Lobo S, Masur H, McGloughlin S, Mehta S, Mehta Y, Mer M, Nunnally M, Oczkowski S, Osborn T, Papathanassoglou E, Perner A, Puskarich M, Roberts J, Schweickert W, Seckel M, Sevransky J, Sprung CL, Welte T, Zimmerman J, Levy M. Executive Summary: Surviving Sepsis Campaign: International Guidelines for the Management of Sepsis and Septic Shock 2021. Crit Care Med. 2021 Nov 1;49(11):1974-1982. doi: 10.1097/CCM.0000000000005357. No abstract available.
- Individual participant dataSharing planned: No
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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.
Adnan Agha principal investigator
United Arab Emirates University
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 Critical Illness and Adrenal Insufficiency, run by Dr Adnan Agha at 1 site in United Arab Emirates.
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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 11 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Arab Emirates. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cortisol levels (nmol/L) (time frame: last 5 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 NCT05741762, which also lists 3 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 11 Jan 2024.