Dobutamine, Milrinone , Pediatrics , Low Cardiac OutputNCT05999487
Dobutamine Versus Milrinone in Management of Critically Ill Low Cardiac Output Pediatric Patients at Cairo University Children's Hospital
A study testing Dobutamine in people with Dobutamine, Milrinone , Pediatrics , Low Cardiac Output, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of the study is to detect wither dobutamine or milrinone have a privilege in the management of low cardiac output pediatric patients over the other. Read more about this study
- Who is it for?
- Ages 1 month to 14 years
- Conditions the study is for
- Dobutamine, Milrinone , Pediatrics , Low Cardiac Output
- What is being tested?
- Dobutamine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- Oct 2023to May 2024
- 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 1 month to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 1-Patients from age of 1 month to 14 years old of both sexes.
- 2-Patients presenting with fluid refractory shock with low cardiac output state, evidenced by sustained hypotension (systolic blood pressure below 5th percentile for age) and end organ dysfunction (altered level of consciousness, renal or hepatic dysfunction)
- 3-Clinical evidence of systemic and/or pulmonary congestion despite use of vasodilators and/or diuretics
- 4-Refractory heart failure requiring admission for inotropic support.
Who cannot join
- 1-All other causes of pediatric shock not in need for inotropic support (eg.isolated hypovolemic shock, anaphylaxis,….)
- 2 - patients not fit for randomization needing specific line of management (eg. Sever hypotension patients with good filling pressure unfit for milrinone , patients previously known having sever pulmonary hypertension not fit for dobutamine ,…)
- 3-post cardiac surgery patients with low cardiac output manifestation.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the study is to detect wither dobutamine or milrinone have a privilege in the management of low cardiac output pediatric patients over the other.
Read the detailed description
Randomized controlled trials (RCTs) enrolling critically ill patients with low cardiac output syndrome (LCOS) admitted at pediatrics emergency and intensive care units ,Cairo University Children's Hospital, identified by treating medical team as requiring initiation of inotropic therapy based on healthcare team assessment of :
- Capillary refill time > 3 sec
- Hypotension (less than the 5th percentile or less than 90/50 mmHg for children 10 years or older (Kleinman et al.,2010) (Haque et al .,2007)
- Oliguria (urine output that is less than 1 mL/kg/h in infants, less than 0.5 mL/kg/h in children ) (Nakano et al.,2022)
- Metabolic acidosis with base excess > -2 (Nakano et al.,2020)
Patient randomization will be done by a computer based generation , serial enveloped numbers will be taken for the patients. Cardiac assessment will be done by a blinded pediatric cardiologist. If at any time the randomly assigned therapy considered to be failed or unsafe to continue, the treating physician will discontinue randomization and will continue with the appropriate medication according to the patients need.
Every patient will be evaluated after the first 24 hours of starting the inotropic therapy by :
- pre and post inotropic therapy ICON measurements ( evaluating cardiac index and systemic vascular resistance pre and post inotropic support)
- pre and post inotropic therapy echocardiography ( evaluating systolic and diastolic dysfunction by M-mode and two dimensional methods) through measuring LV EDD cm, LV ESD cm, LV EDV ml, LVESV ml, FS% , LV mass, EF% , MAPSE cm, TAPSE cm.
- pre and post inotropic therapy clinical assessment of vital signs (heart rate , blood pressure, capillary refill time and urine output as mention before)
- The need of titration up of inotropes :
Milrinone will start by 0.25 , 0.5 , 0.75 we can titrate up with time interval 3 hours after re-assessment.
Dobutamine will start by 5, 10 , 15, 20 we can titrate with time interval 15 mins after re-assesment.
-Time to achievement of therapeutic endpoints for hemodynamics
- adequate blood pressure
- clinically adequate cardiac output ( capillary refill time < 2sec , urine output that is more than 1 mL/kg/h in infants, more than 0.5 mL/kg/h in children, full conscious )
Data will be collected for each patient in form of [ Time Frame: Through first 24 hours up to first week since admission ] :
- Total time on inotropes (in hours)
- Non-invasive or invasive mechanical ventilation Total number of days requiring non-invasive or invasive mechanical ventilation
- Change in cardiac index ([CI] measured with ICON
- Change in systemic vascular resistance [SVR] measured with ICON
- Presence of acute kidney injury (defined as an increase in serum creatinine or a decrease in urine output or both over hours to days.) (Jacob J et al.,2020)
- Absence of metabolic acidosis (BE -2 to 2)
- Arrhythmia requiring medical team intervention, either through electrical or chemical cardioversion or any intravenous anti-arrhythmia medication administration
- Need for up-titration or addition of new vasopressor therapy
- Being tested
- Dobutamine
- Medical subject headings
- Cardiac Output, Low
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DobutamineDrug
Also called milrinone
Patient randomization will be done by a computer based generation , serial enveloped numbers will be taken for the patients. Cardiac assessment will be done by a blinded pediatric cardiologist. If at any time the randomly assigned therapy considered to be failed or unsafe to continue, the treating physician will discontinue randomization and will continue with the appropriate medication according to the patients need.
Milrinone will start by 0.25 , 0.5 , 0.75 we can titrate up with time interval 3 hours after re-assessment.
Dobutamine will start by 5, 10 , 15, 20 we can titrate with time interval 15 mins after re-assesment.
| Study group | Role | What they receive |
|---|---|---|
| patients who will recieve dobutrex | Active comparator | patient presenting with acute heart failure , who will recieve dobutrex as a result of their randomixation , startng dose will be 5 mic , assesing their need for tittration of dose , the need for addition of another inotrope , the prescence of any side effects and the duration of inotropic use for reaching hemodynamically stable state Receives: Drug: Dobutamine |
| patients who will recieve milirinone | Experimental | patient presenting with acute heart failure , who will recieve milirinone as a result of their randomixation , startng dose will be 0.25 mic , assesing their need for tittration of dose , the need for addition of another inotrope , the prescence of any side effects and the duration of inotropic use for reaching hemodynamically stable state Receives: Drug: Dobutamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to achievemnets of theraputeic endpoints of hemodynamics
( normal blood pressure and clinically adequate cardiac output)
Measured: first 24 hrs
Secondary outcomes (4)
Correlation between the used inotropic support and the survival to discharge .
Measured: first week
Total time on inotropes and average length of stay at a pediatric intensive care unit.
Measured: first week
Need for up-titration or addition of other inotropic support.
Measured: first 24 hrs
Frequency of arrythmias and side effects encountered with the use of inotropic support in pediatrics population.
Measured: first 24 hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study startOct 2023 (estimated)
- Primary completionMar 2024 (estimated)
- Study completionMay 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Dobutamine, Milrinone , Pediatrics , Low Cardiac OutputStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe 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
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nada Gamal, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05999487
- Sponsor's protocol ID
- inotropes in pediatrics
- Status last verified
- Aug 2023
- First submitted
- 5 May 2023
- Last updated
- 21 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Haque IU, Zaritsky AL. Analysis of the evidence for the lower limit of systolic and mean arterial pressure in children. Pediatr Crit Care Med. 2007 Mar;8(2):138-44. doi: 10.1097/01.PCC.0000257039.32593.DC.
PubMed 17273118Jacob J, Dannenhoffer J, Rutter A. Acute Kidney Injury. Prim Care. 2020 Dec;47(4):571-584. doi: 10.1016/j.pop.2020.08.008. Epub 2020 Oct 1.
PubMed 33121629Jentzer JC, Coons JC, Link CB, Schmidhofer M. Pharmacotherapy update on the use of vasopressors and inotropes in the intensive care unit. J Cardiovasc Pharmacol Ther. 2015 May;20(3):249-60. doi: 10.1177/1074248414559838. Epub 2014 Nov 28.
PubMed 25432872Kleinman ME, Chameides L, Schexnayder SM, Samson RA, Hazinski MF, Atkins DL, Berg MD, de Caen AR, Fink EL, Freid EB, Hickey RW, Marino BS, Nadkarni VM, Proctor LT, Qureshi FA, Sartorelli K, Topjian A, van der Jagt EW, Zaritsky AL; American Heart Association. Pediatric advanced life support: 2010 American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Pediatrics. 2010 Nov;126(5):e1361-99. doi: 10.1542/peds.2010-2972D. Epub 2010 Oct 18. No abstract available.
PubMed 20956434Lewis TC, Aberle C, Altshuler D, Piper GL, Papadopoulos J. Comparative Effectiveness and Safety Between Milrinone or Dobutamine as Initial Inotrope Therapy in Cardiogenic Shock. J Cardiovasc Pharmacol Ther. 2019 Mar;24(2):130-138. doi: 10.1177/1074248418797357. Epub 2018 Sep 2.
PubMed 30175599Mathew R, Di Santo P, Jung RG, Marbach JA, Hutson J, Simard T, Ramirez FD, Harnett DT, Merdad A, Almufleh A, Weng W, Abdel-Razek O, Fernando SM, Kyeremanteng K, Bernick J, Wells GA, Chan V, Froeschl M, Labinaz M, Le May MR, Russo JJ, Hibbert B. Milrinone as Compared with Dobutamine in the Treatment of Cardiogenic Shock. N Engl J Med. 2021 Aug 5;385(6):516-525. doi: 10.1056/NEJMoa2026845.
PubMed 34347952Masse L, Antonacci M. Low cardiac output syndrome: identification and management. Crit Care Nurs Clin North Am. 2005 Dec;17(4):375-83, x. doi: 10.1016/j.ccell.2005.07.005.
PubMed 16344207Nakano H, Nagai T, Honda Y, Honda S, Iwakami N, Matsumoto C, Asaumi Y, Aiba T, Noguchi T, Kusano K, Yokoyama H, Ogawa H, Yasuda S, Chikamori T, Anzai T. Prognostic value of base excess as indicator of acid-base balance in acute heart failure. Eur Heart J Acute Cardiovasc Care. 2020 Aug;9(5):399-405. doi: 10.1177/2048872619898781. Epub 2020 Jan 23.
PubMed 31970993Nakano H. Oliguria. https://emedicine.medscape.com/article/983156-overview. Updated: Feb 28, 2022. Accessed at 15-12-2022.
Uhlig K, Efremov L, Tongers J, Frantz S, Mikolajczyk R, Sedding D, Schumann J. Inotropic agents and vasodilator strategies for the treatment of cardiogenic shock or low cardiac output syndrome. Cochrane Database Syst Rev. 2020 Nov 5;11(11):CD009669. doi: 10.1002/14651858.CD009669.pub4.
PubMed 33152122
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dobutamine Versus Milrinone in Management of Critically Ill Low Cardiac Output Pediatric Patients at Cairo University Children's Hospital
- ClinicalTrials.gov ID
- NCT05999487
- Acronym / sponsor ID
- inotropes in pediatrics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Oct 2023 (estimated)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- May 2024 (estimated)
- First posted
- 21 Aug 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.
The aim of the study is to detect wither dobutamine or milrinone have a privilege in the management of low cardiac output pediatric patients over the other.
Detailed description
Randomized controlled trials (RCTs) enrolling critically ill patients with low cardiac output syndrome (LCOS) admitted at pediatrics emergency and intensive care units ,Cairo University Children's Hospital, identified by treating medical team as requiring initiation of inotropic therapy based on healthcare team assessment of :
- Capillary refill time > 3 sec
- Hypotension (less than the 5th percentile or less than 90/50 mmHg for children 10 years or older (Kleinman et al.,2010) (Haque et al .,2007)
- Oliguria (urine output that is less than 1 mL/kg/h in infants, less than 0.5 mL/kg/h in children ) (Nakano et al.,2022)
- Metabolic acidosis with base excess > -2 (Nakano et al.,2020)
Patient randomization will be done by a computer based generation , serial enveloped numbers will be taken for the patients. Cardiac assessment will be done by a blinded pediatric cardiologist. If at any time the randomly assigned therapy considered to be failed or unsafe to continue, the treating physician will discontinue randomization and will continue with the appropriate medication according to the patients need.
Every patient will be evaluated after the first 24 hours of starting the inotropic therapy by :
- pre and post inotropic therapy ICON measurements ( evaluating cardiac index and systemic vascular resistance pre and post inotropic support)
- pre and post inotropic therapy echocardiography ( evaluating systolic and diastolic dysfunction by M-mode and two dimensional methods) through measuring LV EDD cm, LV ESD cm, LV EDV ml, LVESV ml, FS% , LV mass, EF% , MAPSE cm, TAPSE cm.
- pre and post inotropic therapy clinical assessment of vital signs (heart rate , blood pressure, capillary refill time and urine output as mention before)
- The need of titration up of inotropes :
Milrinone will start by 0.25 , 0.5 , 0.75 we can titrate up with time interval 3 hours after re-assessment.
Dobutamine will start by 5, 10 , 15, 20 we can titrate with time interval 15 mins after re-assesment.
-Time to achievement of therapeutic endpoints for hemodynamics
- adequate blood pressure
- clinically adequate cardiac output ( capillary refill time < 2sec , urine output that is more than 1 mL/kg/h in infants, more than 0.5 mL/kg/h in children, full conscious )
Data will be collected for each patient in form of [ Time Frame: Through first 24 hours up to first week since admission ] :
- Total time on inotropes (in hours)
- Non-invasive or invasive mechanical ventilation Total number of days requiring non-invasive or invasive mechanical ventilation
- Change in cardiac index ([CI] measured with ICON
- Change in systemic vascular resistance [SVR] measured with ICON
- Presence of acute kidney injury (defined as an increase in serum creatinine or a decrease in urine output or both over hours to days.) (Jacob J et al.,2020)
- Absence of metabolic acidosis (BE -2 to 2)
- Arrhythmia requiring medical team intervention, either through electrical or chemical cardioversion or any intravenous anti-arrhythmia medication administration
- Need for up-titration or addition of new vasopressor therapy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients who will recieve dobutrex | Active comparator | Drug: Dobutaminepatient presenting with acute heart failure , who will recieve dobutrex as a result of their randomixation , startng dose will be 5 mic , assesing their need for tittration of dose , the need for addition of another inotrope , the prescence of any side effects and the duration of inotropic use for reaching hemodynamically stable state |
| patients who will recieve milirinone | Experimental | Drug: Dobutaminepatient presenting with acute heart failure , who will recieve milirinone as a result of their randomixation , startng dose will be 0.25 mic , assesing their need for tittration of dose , the need for addition of another inotrope , the prescence of any side effects and the duration of inotropic use for reaching hemodynamically stable state |
Who may qualify
- Ages
- 1 month to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 1-Patients from age of 1 month to 14 years old of both sexes.
- 2-Patients presenting with fluid refractory shock with low cardiac output state, evidenced by sustained hypotension (systolic blood pressure below 5th percentile for age) and end organ dysfunction (altered level of consciousness, renal or hepatic dysfunction)
- 3-Clinical evidence of systemic and/or pulmonary congestion despite use of vasodilators and/or diuretics
- 4-Refractory heart failure requiring admission for inotropic support.
Key exclusion criteria (3 listed)
- 1-All other causes of pediatric shock not in need for inotropic support (eg.isolated hypovolemic shock, anaphylaxis,….)
- 2 - patients not fit for randomization needing specific line of management (eg. Sever hypotension patients with good filling pressure unfit for milrinone , patients previously known having sever pulmonary hypertension not fit for dobutamine ,…)
- 3-post cardiac surgery patients with low cardiac output manifestation.
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 |
|---|---|---|
| DobutamineAlso: milrinonePatient randomization will be done by a computer based generation , serial enveloped numbers will be taken for the patients. Cardiac assessment will be done by a blinded pediatric cardiologist. If at any time the randomly assigned therapy considered to be failed or unsafe to continue, the treating physician will discontinue randomization and will continue with the appropriate medication according to the patients need. Milrinone will start by 0.25 , 0.5 , 0.75 we can titrate up with time interval 3 hours after re-assessment. Dobutamine will start by 5, 10 , 15, 20 we can titrate with time interval 15 mins after re-assesment. | Drug | patients who will recieve dobutrex, patients who will recieve milirinone |
Primary outcome
time to achievemnets of theraputeic endpoints of hemodynamics
Time frame: first 24 hrs
( normal blood pressure and clinically adequate cardiac output)
4 secondary outcomes
Correlation between the used inotropic support and the survival to discharge .
Time frame: first week
Total time on inotropes and average length of stay at a pediatric intensive care unit.
Time frame: first week
Need for up-titration or addition of other inotropic support.
Time frame: first 24 hrs
Frequency of arrythmias and side effects encountered with the use of inotropic support in pediatrics population.
Time frame: first 24 hrs
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2023.
- Background: PubMed 17273118Haque IU, Zaritsky AL. Analysis of the evidence for the lower limit of systolic and mean arterial pressure in children. Pediatr Crit Care Med. 2007 Mar;8(2):138-44. doi: 10.1097/01.PCC.0000257039.32593.DC.
- Background: PubMed 33121629Jacob J, Dannenhoffer J, Rutter A. Acute Kidney Injury. Prim Care. 2020 Dec;47(4):571-584. doi: 10.1016/j.pop.2020.08.008. Epub 2020 Oct 1.
- Background: PubMed 25432872Jentzer JC, Coons JC, Link CB, Schmidhofer M. Pharmacotherapy update on the use of vasopressors and inotropes in the intensive care unit. J Cardiovasc Pharmacol Ther. 2015 May;20(3):249-60. doi: 10.1177/1074248414559838. Epub 2014 Nov 28.
- Background: PubMed 20956434Kleinman ME, Chameides L, Schexnayder SM, Samson RA, Hazinski MF, Atkins DL, Berg MD, de Caen AR, Fink EL, Freid EB, Hickey RW, Marino BS, Nadkarni VM, Proctor LT, Qureshi FA, Sartorelli K, Topjian A, van der Jagt EW, Zaritsky AL; American Heart Association. Pediatric advanced life support: 2010 American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Pediatrics. 2010 Nov;126(5):e1361-99. doi: 10.1542/peds.2010-2972D. Epub 2010 Oct 18. No abstract available.
- Background: PubMed 30175599Lewis TC, Aberle C, Altshuler D, Piper GL, Papadopoulos J. Comparative Effectiveness and Safety Between Milrinone or Dobutamine as Initial Inotrope Therapy in Cardiogenic Shock. J Cardiovasc Pharmacol Ther. 2019 Mar;24(2):130-138. doi: 10.1177/1074248418797357. Epub 2018 Sep 2.
- Background: PubMed 34347952Mathew R, Di Santo P, Jung RG, Marbach JA, Hutson J, Simard T, Ramirez FD, Harnett DT, Merdad A, Almufleh A, Weng W, Abdel-Razek O, Fernando SM, Kyeremanteng K, Bernick J, Wells GA, Chan V, Froeschl M, Labinaz M, Le May MR, Russo JJ, Hibbert B. Milrinone as Compared with Dobutamine in the Treatment of Cardiogenic Shock. N Engl J Med. 2021 Aug 5;385(6):516-525. doi: 10.1056/NEJMoa2026845.
- Background: PubMed 16344207Masse L, Antonacci M. Low cardiac output syndrome: identification and management. Crit Care Nurs Clin North Am. 2005 Dec;17(4):375-83, x. doi: 10.1016/j.ccell.2005.07.005.
- Background: PubMed 31970993Nakano H, Nagai T, Honda Y, Honda S, Iwakami N, Matsumoto C, Asaumi Y, Aiba T, Noguchi T, Kusano K, Yokoyama H, Ogawa H, Yasuda S, Chikamori T, Anzai T. Prognostic value of base excess as indicator of acid-base balance in acute heart failure. Eur Heart J Acute Cardiovasc Care. 2020 Aug;9(5):399-405. doi: 10.1177/2048872619898781. Epub 2020 Jan 23.
- BackgroundNakano H. Oliguria. https://emedicine.medscape.com/article/983156-overview. Updated: Feb 28, 2022. Accessed at 15-12-2022.
- Background: PubMed 33152122Uhlig K, Efremov L, Tongers J, Frantz S, Mikolajczyk R, Sedding D, Schumann J. Inotropic agents and vasodilator strategies for the treatment of cardiogenic shock or low cardiac output syndrome. Cochrane Database Syst Rev. 2020 Nov 5;11(11):CD009669. doi: 10.1002/14651858.CD009669.pub4.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dobutamine in people with Dobutamine, Milrinone , Pediatrics , Low Cardiac Output, run by Cairo University at 1 site in Egypt.
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 4 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: status not confirmed, as of the sponsor's last update on 21 Aug 2023. 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 Egypt. 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?
Contact nada gamal (01062094645, nada.g276@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time to achievemnets of theraputeic endpoints of hemodynamics (time frame: first 24 hrs). 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 NCT05999487, which also lists 10 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 21 Aug 2023.