Critical IllnessNCT07846995
Predicting Early Circulatory Deterioration After Short-Acting Beta-Blocker Treatment in Intensive Care Patients
An observational study of Critical Illness, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
This retrospective observational study used existing intensive care records to examine whether heart rate and blood pressure measured before short-acting beta-blocker treatment could help predict early signs of worsening circulation recorded after treatment. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Critical Illness
- What is being tested?
- Esmolol and Landiolol
- Type of treatment
- Injection or infusion
- How many people
- 2,541 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2026to 22 Sep 2026
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: Patients receiving intravenous short-acting beta-blockers during routine intensive care, identified retrospectively from electronic health records. The development population comprised patients treated with esmolol or landiolol at Zhongshan Hospital, Fudan University, identified through ICCA. External validation populations comprised esmolol-treated patients in MIMIC-IV, eICU, AmsterdamUMCdb, HiRID, and SICdb. Analyses used the first qualifying treatment index per patient and required preserved baseline mean arterial pressure, available pretreatment predictors, post-index blood pressure monitoring, and documented ICU presence through 180 minutes. Treatment was determined by clinical care, not assigned by the study.
Who may be able to join
- ICU patients with routinely collected medication and physiological records in ICCA at Zhongshan Hospital, Fudan University, or in MIMIC-IV, eICU, AmsterdamUMCdb, HiRID, or SICdb.
- Documented intravenous esmolol or landiolol treatment in ICCA, or documented intravenous esmolol treatment in the external validation cohorts.
- An identifiable treatment index according to database-specific medication-record rules. ICCA required a timestamp-verified treatment start. In eICU, the index was the first documented positive-rate infusion record rather than a verified initiation time.
- The last recorded mean arterial pressure within 30 minutes before the treatment index was at least 65 mmHg.
- At least one mean arterial pressure measurement was recorded after the treatment index and within 180 minutes.
- Documented ICU presence extended through 180 minutes after the treatment index.
- Pretreatment heart rate, diastolic blood pressure, and pulse pressure were available to calculate the model predictors within the 120 minutes before the treatment index.
Who cannot join
- Medication records that could not be mapped unambiguously to the patient, ICU stay, study drug, or treatment index.
- In ICCA, candidate starts with a conflicting same-time stop or an unresolved continuation or restart.
- No qualifying baseline mean arterial pressure measurement, or a last baseline mean arterial pressure below 65 mmHg.
- No mean arterial pressure measurement in the 180-minute post-index window.
- Insufficient documented ICU presence through 180 minutes after the treatment index.
- Missing pretreatment measurements required to calculate the model predictors.
Show all 10Show fewer
- Record-selection rules:
- The first accepted treatment index per patient was selected before assessing outcome completeness in each cohort; later courses were not substituted when this first index failed eligibility requirements.
- Duplicate medication records at the same patient, stay, drug, and timestamp were collapsed.
- Physiological measurements recorded exactly at the treatment index were excluded because their temporal order relative to drug administration was uncertain.
Trial locations and contacts
1 site in 1 country.
China1 site
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200032
About this study
Official title: Pretreatment Haemodynamic Prediction of Recorded Early Circulatory Deterioration After Documented Short-Acting Beta-Blocker Treatment in Intensive Care: A Retrospective Multicohort Study
This retrospective observational study used existing intensive care records to examine whether heart rate and blood pressure measured before short-acting beta-blocker treatment could help predict early signs of worsening circulation recorded after treatment.
The study included patients who had received intravenous esmolol or landiolol during routine care. Researchers did not assign treatment or change patient care. The main analysis used records from Zhongshan Hospital, Fudan University. Additional intensive care databases were used to evaluate whether a prediction model developed at this hospital could be applied to other patient populations.
Read more
The main questions were whether pretreatment heart rate and blood pressure could predict recorded circulatory changes, whether combining these measurements improved prediction over simpler blood pressure measures, and whether differences in blood pressure monitoring affected the findings.
The main outcome combined a recorded fall in blood pressure, initiation or escalation of norepinephrine (a medicine used to support blood pressure), or early discontinuation of the same beta-blocker. Blood pressure and norepinephrine changes were assessed during the first three hours after the treatment index, and drug discontinuation during the first hour. External database analyses focused on recorded low blood pressure during the first three hours.
The study evaluated prediction among patients who had already received treatment. It was not designed to determine whether beta-blockers caused these events or whether a patient should receive a beta-blocker. Data collection and the analyses described here were completed before registration.
Read the detailed description
Study rationale and design
This retrospective, multicohort observational study examined early recorded haemodynamic deterioration among intensive care patients with documented short-acting intravenous beta-blocker treatment. The purpose was to develop and evaluate a compact pretreatment prediction model using routinely collected physiological measurements. Treatment decisions were made during routine clinical care, independently of this study.
The development cohort was derived from the IntelliSpace Critical Care and Anesthesia (ICCA) system at Zhongshan Hospital, Fudan University. External evaluation used MIMIC-IV, the eICU Collaborative Research Database, AmsterdamUMCdb, HiRID, and the Salzburg Intensive Care Database (SICdb).
Analytical framework
The primary ICCA analysis used the first accepted, timestamp-verified esmolol or landiolol start per patient. Pretreatment predictors were median heart rate, diastolic blood pressure, and pulse pressure during the 120 minutes before the treatment index. Measurements recorded exactly at the index were excluded because their order relative to drug administration could not be established.
The primary analysis was restricted to patients with a qualifying baseline mean arterial pressure, observable post-index blood pressure, and documented ICU presence through the three-hour observation period. Outcome classification was based on recorded events. Absence of a qualifying recorded signal was not interpreted as proof that no physiological deterioration or adverse drug reaction had occurred. Early drug discontinuation was not assumed to indicate intolerance because reasons for stopping were unavailable.
Model development and evaluation
An L2-penalized logistic regression model combined the three pretreatment predictors. A separate model added a heart-rate-by-diastolic-blood-pressure interaction to assess its incremental predictive contribution. Internal performance was evaluated using patient-isolated nested cross-validation, with preprocessing and penalty selection conducted within training data. Discrimination, calibration, and overall prediction error were assessed.
A separate model for the narrower outcome of newly recorded mean arterial pressure below 65 mmHg within three hours was fitted in ICCA and applied to external cohorts without refitting or recalibration. External medication indices were reconstructed using database-specific records. In eICU, the index represented the earliest documented positive-rate infusion record rather than a verified treatment initiation time. External evaluation distinguished discrimination from the accuracy of absolute risk estimates.
Additional analyses
Sensitivity analyses examined the composite outcome without early drug discontinuation, the blood-pressure-only outcome, and the esmolol-only population. Additional analyses compared the three-predictor model with simpler blood pressure models and assessed the influence of monitoring frequency by selecting blood pressure measurements within standardized post-index time intervals. Exploratory analyses examined early heart-rate and blood-pressure patterns.
Timing of registration and analysis specification
This study was registered retrospectively after data collection and the analyses described here had been completed. The outcome amendment, predictor set, model family, validation procedures, sensitivity analyses, and external evaluation thresholds were specified sequentially before their corresponding analyses, after feasibility work had established sample and event counts. Exploratory early-pattern analyses were specified after completion of the primary models. Simpler-model comparisons, monitoring-frequency sensitivity analyses, and additional population descriptions were added following review of the completed manuscript, with their analysis rules specified before execution. These stages do not constitute prospective registration.
Interpretation
The study characterizes recorded risk conditional on documented treatment and available monitoring. It does not estimate the causal effect of beta-blocker treatment, establish comparative drug safety, or determine which patients should start or avoid treatment.
- Conditions
- Critical Illness
- Being tested
- Esmolol, Landiolol
- Keywords
- Short-Acting Beta-Blockers, Intensive Care, Hemodynamics, Prediction Model
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EsmololDrug
Intravenous esmolol administered during routine intensive care, as documented in existing medication records. Treatment selection, dose, and duration were determined by treating clinicians. Esmolol exposure was identified retrospectively; no treatment was assigned or modified by the study.
LandiololDrug
Intravenous landiolol administered during routine intensive care, as documented in existing medication records. Treatment selection, dose, and duration were determined by treating clinicians. Landiolol exposure was identified retrospectively; no treatment was assigned or modified by the study.
| Study group | Role | What they receive |
|---|---|---|
| ICU Patients Receiving Short-Acting Intravenous Beta-Blockers | Patients receiving intravenous esmolol or landiolol during routine intensive care, identified retrospectively from six data sources. ICCA at Zhongshan Hospital, Fudan University, provided 1,354 esmolol- or landiolol-treated patients for model development and internal validation. External esmolol cohorts comprised MIMIC-IV (625), eICU (191), AmsterdamUMCdb (56), HiRID (88), and SICdb (227). The first eligible treatment index per patient was selected within each source. Eligibility required baseline MAP of at least 65 mmHg, complete pretreatment predictors, post-index MAP observation, and ICU presence through 180 minutes. ICCA assessed the recorded composite outcome; external cohorts evaluated the frozen MAP-only model without refitting, with AmsterdamUMCdb limited to descriptive evaluation. Treatment was not assigned by the study. Esmolol and landiolol were alternative recorded exposures, not a required combination. Receives: Drug: Esmolol; Drug: Landiolol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of ICCA Patients With Recorded Early Haemodynamic Deterioration
Percentage of eligible ICCA patients with at least one recorded component of the composite outcome: (1) new mean arterial pressure (MAP) below 65 mmHg during (0,180] minutes after the treatment index; (2) documented norepinephrine initiation, a within-source change from zero to a positive rate, or a greater than 20% increase from a positive pre-index rate during (0,180] minutes; or (3) an explicit stop record for the same study beta-blocker during (0,60] minutes. Norepinephrine changes were compared only within the same data source and measurement unit. Eligible patients had a last MAP of at least 65 mmHg during [-30,0) minutes, post-index MAP observation, and ICU presence through 180 minutes. Patients meeting these observation requirements without a qualifying recorded signal were classified as having no recorded composite event. This outcome does not establish drug causality, and early stopping does not necessarily indicate intolerance. This composite was assessed in ICCA only.
Measured: From the documented treatment start to 180 minutes afterward; same-drug discontinuation assessed within the first 60 minutes.
Secondary outcomes (1)
Percentage of Patients With Newly Recorded Hypotension
Percentage of eligible patients with at least one recorded mean arterial pressure (MAP) below 65 mmHg during (0,180] minutes after the database-specific treatment index, following a last recorded MAP of at least 65 mmHg during [-30,0) minutes. Patients were required to have post-index MAP observation and documented ICU presence through 180 minutes. This MAP-only outcome was evaluated in ICCA and separately in MIMIC-IV, eICU, AmsterdamUMCdb, HiRID, and SICdb. Norepinephrine changes and beta-blocker discontinuation were not components of this outcome. In eICU, the index was the first documented positive-rate infusion record rather than a verified treatment initiation.
Measured: Within 180 minutes after the database-specific treatment index
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2026
- Study start1 Aug 2026
- Primary completion20 Sep 2026
- Study completion22 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,541 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07846995
- Sponsor's protocol ID
- B2026-484-BBlocker
- Status last verified
- Sep 2026
- First submitted
- 23 Sep 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pretreatment Haemodynamic Prediction of Recorded Early Circulatory Deterioration After Documented Short-Acting Beta-Blocker Treatment in Intensive Care: A Retrospective Multicohort Study
- ClinicalTrials.gov ID
- NCT07846995
- Acronym / sponsor ID
- B2026-484-BBlocker
- Conditions
- Critical Illness
- Keywords
- Short-Acting Beta-Blockers, Intensive Care, Hemodynamics, Prediction Model
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,541 participants (actual)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 1 Aug 2026 (actual)
- Primary completion
- 20 Sep 2026 (actual)
- Study completion
- 22 Sep 2026 (actual)
- First posted
- 29 Sep 2026 (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 retrospective observational study used existing intensive care records to examine whether heart rate and blood pressure measured before short-acting beta-blocker treatment could help predict early signs of worsening circulation recorded after treatment.
The study included patients who had received intravenous esmolol or landiolol during routine care. Researchers did not assign treatment or change patient care. The main analysis used records from Zhongshan Hospital, Fudan University. Additional intensive care databases were used to evaluate whether a prediction model developed at this hospital could be applied to other patient populations.
The main questions were whether pretreatment heart rate and blood pressure could predict recorded circulatory changes, whether combining these measurements improved prediction over simpler blood pressure measures, and whether differences in blood pressure monitoring affected the findings.
The main outcome combined a recorded fall in blood pressure, initiation or escalation of norepinephrine (a medicine used to support blood pressure), or early discontinuation of the same beta-blocker. Blood pressure and norepinephrine changes were assessed during the first three hours after the treatment index, and drug discontinuation during the first hour. External database analyses focused on recorded low blood pressure during the first three hours.
The study evaluated prediction among patients who had already received treatment. It was not designed to determine whether beta-blockers caused these events or whether a patient should receive a beta-blocker. Data collection and the analyses described here were completed before registration.
Detailed description
Study rationale and design
This retrospective, multicohort observational study examined early recorded haemodynamic deterioration among intensive care patients with documented short-acting intravenous beta-blocker treatment. The purpose was to develop and evaluate a compact pretreatment prediction model using routinely collected physiological measurements. Treatment decisions were made during routine clinical care, independently of this study.
The development cohort was derived from the IntelliSpace Critical Care and Anesthesia (ICCA) system at Zhongshan Hospital, Fudan University. External evaluation used MIMIC-IV, the eICU Collaborative Research Database, AmsterdamUMCdb, HiRID, and the Salzburg Intensive Care Database (SICdb).
Analytical framework
The primary ICCA analysis used the first accepted, timestamp-verified esmolol or landiolol start per patient. Pretreatment predictors were median heart rate, diastolic blood pressure, and pulse pressure during the 120 minutes before the treatment index. Measurements recorded exactly at the index were excluded because their order relative to drug administration could not be established.
The primary analysis was restricted to patients with a qualifying baseline mean arterial pressure, observable post-index blood pressure, and documented ICU presence through the three-hour observation period. Outcome classification was based on recorded events. Absence of a qualifying recorded signal was not interpreted as proof that no physiological deterioration or adverse drug reaction had occurred. Early drug discontinuation was not assumed to indicate intolerance because reasons for stopping were unavailable.
Model development and evaluation
An L2-penalized logistic regression model combined the three pretreatment predictors. A separate model added a heart-rate-by-diastolic-blood-pressure interaction to assess its incremental predictive contribution. Internal performance was evaluated using patient-isolated nested cross-validation, with preprocessing and penalty selection conducted within training data. Discrimination, calibration, and overall prediction error were assessed.
A separate model for the narrower outcome of newly recorded mean arterial pressure below 65 mmHg within three hours was fitted in ICCA and applied to external cohorts without refitting or recalibration. External medication indices were reconstructed using database-specific records. In eICU, the index represented the earliest documented positive-rate infusion record rather than a verified treatment initiation time. External evaluation distinguished discrimination from the accuracy of absolute risk estimates.
Additional analyses
Sensitivity analyses examined the composite outcome without early drug discontinuation, the blood-pressure-only outcome, and the esmolol-only population. Additional analyses compared the three-predictor model with simpler blood pressure models and assessed the influence of monitoring frequency by selecting blood pressure measurements within standardized post-index time intervals. Exploratory analyses examined early heart-rate and blood-pressure patterns.
Timing of registration and analysis specification
This study was registered retrospectively after data collection and the analyses described here had been completed. The outcome amendment, predictor set, model family, validation procedures, sensitivity analyses, and external evaluation thresholds were specified sequentially before their corresponding analyses, after feasibility work had established sample and event counts. Exploratory early-pattern analyses were specified after completion of the primary models. Simpler-model comparisons, monitoring-frequency sensitivity analyses, and additional population descriptions were added following review of the completed manuscript, with their analysis rules specified before execution. These stages do not constitute prospective registration.
Interpretation
The study characterizes recorded risk conditional on documented treatment and available monitoring. It does not estimate the causal effect of beta-blocker treatment, establish comparative drug safety, or determine which patients should start or avoid treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICU Patients Receiving Short-Acting Intravenous Beta-Blockers | – | Drug: Esmolol, Drug: LandiololPatients receiving intravenous esmolol or landiolol during routine intensive care, identified retrospectively from six data sources. ICCA at Zhongshan Hospital, Fudan University, provided 1,354 esmolol- or landiolol-treated patients for model development and internal validation. External esmolol cohorts comprised MIMIC-IV (625), eICU (191), AmsterdamUMCdb (56), HiRID (88), and SICdb (227). The first eligible treatment index per patient was selected within each source. Eligibility required baseline MAP of at least 65 mmHg, complete pretreatment predictors, post-index MAP observation, and ICU presence through 180 minutes. ICCA assessed the recorded composite outcome; external cohorts evaluated the frozen MAP-only model without refitting, with AmsterdamUMCdb limited to descriptive evaluation. Treatment was not assigned by the study. Esmolol and landiolol were alternative recorded exposures, not a required combination. |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients receiving intravenous short-acting beta-blockers during routine intensive care, identified retrospectively from electronic health records. The development population comprised patients treated with esmolol or landiolol at Zhongshan Hospital, Fudan University, identified through ICCA. External validation populations comprised esmolol-treated patients in MIMIC-IV, eICU, AmsterdamUMCdb, HiRID, and SICdb. Analyses used the first qualifying treatment index per patient and required preserved baseline mean arterial pressure, available pretreatment predictors, post-index blood pressure monitoring, and documented ICU presence through 180 minutes. Treatment was determined by clinical care, not assigned by the study.
Key inclusion criteria (7 listed)
- ICU patients with routinely collected medication and physiological records in ICCA at Zhongshan Hospital, Fudan University, or in MIMIC-IV, eICU, AmsterdamUMCdb, HiRID, or SICdb.
- Documented intravenous esmolol or landiolol treatment in ICCA, or documented intravenous esmolol treatment in the external validation cohorts.
- An identifiable treatment index according to database-specific medication-record rules. ICCA required a timestamp-verified treatment start. In eICU, the index was the first documented positive-rate infusion record rather than a verified initiation time.
- The last recorded mean arterial pressure within 30 minutes before the treatment index was at least 65 mmHg.
- At least one mean arterial pressure measurement was recorded after the treatment index and within 180 minutes.
Key exclusion criteria (10 listed)
- Medication records that could not be mapped unambiguously to the patient, ICU stay, study drug, or treatment index.
- In ICCA, candidate starts with a conflicting same-time stop or an unresolved continuation or restart.
- No qualifying baseline mean arterial pressure measurement, or a last baseline mean arterial pressure below 65 mmHg.
- No mean arterial pressure measurement in the 180-minute post-index window.
- Insufficient documented ICU presence through 180 minutes after the treatment index.
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 |
|---|---|---|
| EsmololIntravenous esmolol administered during routine intensive care, as documented in existing medication records. Treatment selection, dose, and duration were determined by treating clinicians. Esmolol exposure was identified retrospectively; no treatment was assigned or modified by the study. | Drug | ICU Patients Receiving Short-Acting Intravenous Beta-Blockers |
| LandiololIntravenous landiolol administered during routine intensive care, as documented in existing medication records. Treatment selection, dose, and duration were determined by treating clinicians. Landiolol exposure was identified retrospectively; no treatment was assigned or modified by the study. | Drug | ICU Patients Receiving Short-Acting Intravenous Beta-Blockers |
Primary outcome
Percentage of ICCA Patients With Recorded Early Haemodynamic Deterioration
Time frame: From the documented treatment start to 180 minutes afterward; same-drug discontinuation assessed within the first 60 minutes.
Percentage of eligible ICCA patients with at least one recorded component of the composite outcome: (1) new mean arterial pressure (MAP) below 65 mmHg during (0,180] minutes after the treatment index; (2) documented norepinephrine initiation, a within-source change from zero to a positive rate, or a greater than 20% increase from a positive pre-index rate during (0,180] minutes; or (3) an explicit stop record for the same study beta-blocker during (0,60] minutes. Norepinephrine changes were compared only within the same data source and measurement unit. Eligible patients had a last MAP of at least 65 mmHg during [-30,0) minutes, post-index MAP observation, and ICU presence through 180 minutes. Patients meeting these observation requirements without a qualifying recorded signal were classified as having no recorded composite event. This outcome does not establish drug causality, and early stopping does not necessarily indicate intolerance. This composite was assessed in ICCA only.
1 secondary outcome
Percentage of Patients With Newly Recorded Hypotension
Time frame: Within 180 minutes after the database-specific treatment index
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 29 Sep 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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, run by Shanghai Zhongshan Hospital at 1 site in China.
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 10 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 29 Sep 2026. 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 China. 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?
Percentage of ICCA Patients With Recorded Early Haemodynamic Deterioration (time frame: From the documented treatment start to 180 minutes afterward; same-drug discontinuation assessed within the first 60 minutes.). 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 29 Sep 2026.