TraumaProTIMNCT04291521
Prospective Study of Induction Medications Used in the Trauma RSI
An observational study of Trauma and Rapid Sequence Intubation, run by University of Southern California at 1 site in United States.
Trial summary
To compare the outcomes of the use of propofol, etomidate, and ketamine as induction agents for adult trauma patients undergoing intubation within 24 hours of admission. The primary goal is to determine the ideal agent that should be used in this patient population for intubations. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Trauma, Rapid Sequence Intubation
- What is being tested?
- Ketamine, Etomidate and Propofol
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2027to 30 Jul 2029
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult trauma patients requiring intubation within 24 hours of hospital admission.
Who may be able to join
- Trauma patients >=18 yo requiring intubation within 24 hours of admission in either the ED or OR
- Patients received propofol, etomidate, or ketamine for induction agent
Who cannot join
- Patients who were intubated without induction agent medications
- Patients intubated outside of the hospital or in the field
- Patients who were intubated with an induction agent other than etomidate, ketamine, or propofol
Trial locations and contacts
1 site in 1 country.
United States1 site
Keck School of Medicine of the University of Southern California
Los Angeles, California, 90033
About this study
Official title: Prospective Study of Induction Medications Used in the Rapid Sequence Intubation of Trauma Patients and a Comparison of Effects on Outcomes
To compare the outcomes of the use of propofol, etomidate, and ketamine as induction agents for adult trauma patients undergoing intubation within 24 hours of admission. The primary goal is to determine the ideal agent that should be used in this patient population for intubations.
Read the detailed description
Rationale:
Although rapid sequence intubation (RSI) is commonly used in the emergency department (ED) or operating room (OR) for trauma patients, there is not one induction medication which has been deemed the drug of choice for this particular use. There is a wide variation in induction agents used by providers performing RSIs, including propofol, ketamine, methohexital, midazolam, fentanyl, and etomidate. However, no society guidelines exist on the induction agent of choice in trauma for either hemodynamically stable or unstable patients. The purpose of this study is to compare the effects of 3 of the most commonly used induction agents (propofol, etomidate, and ketamine) for RSIs in adult trauma patients on outcomes, such as mortality, and hemodynamic status. Ultimately, the investigators would like to lay the groundwork for developing guidelines that define the ideal induction agent for trauma RSIs.
Intervention: Giving propofol, ketamine, or etomidate as the induction medication for a rapid sequence intubation in trauma patients requiring intubation within 24 hours of admission.
Objectives/Purpose: The purpose of this study is to compare the effects of 3 of the most commonly used induction agents (propofol, etomidate, and ketamine) for RSIs in adult trauma patients on outcomes such as mortality. Additionally, how each agent effects patients' hemodynamic status will be evaluated. Additional outcomes of these medications will be studied in three subsets of patients: 1. those with traumatic brain injuries, 2. elderly patients (>=65-years-old), and 3. those with a low shock index (<0.9) compared to a high shock index (>0.9). Finally, the practices and outcomes of RSIs performed in the ED versus the OR will be compared. Ultimately, the investigators would like to lay the groundwork for developing guidelines that define the ideal induction agent for trauma RSIs.
Study population: Adult trauma patients undergoing RSI within 24 hours of hospital admission
Methodology: A multicenter, prospective observational study will be performed.
Endpoints: In-hospital mortality, 28-day mortality, ICU and total hospital length of stay, complications, hypotension and vasopressor use 30 minutes and 24 hours after intubation, mechanical ventilator days, and discharge disposition
Statistic plan: Data will be entered into a password-protected online data collection tool known as RedCap, and analyzed using SAS version 9.4 (SAS Institute, Inc., Cary, NC).
- Conditions
- Trauma, Rapid Sequence Intubation
- Keywords
- trauma, induction medications, rapid sequence intubations, outcomes
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
Also called Ketalar
Administering ketamine as an induction medication for intubating adult trauma patients within 24 hours of hospital admission.
EtomidateDrug
Also called Amidate
Administering etomidate as an induction medication for intubating adult trauma patients within 24 hours of hospital admission.
PropofolDrug
Also called Diprivan
Administering propofol as an induction medication for intubating adult trauma patients within 24 hours of hospital admission.
| Study group | Role | What they receive |
|---|---|---|
| Adult trauma patients requiring RSI | Patients who received an induction medication for intubation. Receives: Drug: Ketamine; Drug: Etomidate; Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
in-hospital mortality
mortality
Measured: through study completion, an average of 1 year
Secondary outcomes (10)
total hospital length of stay
days
Measured: through study completion, an average of 1 year
intensive care unit length of stay
days
Measured: through study completion, an average of 1 year
mechanical ventilator days
days
Measured: through study completion, an average of 1 year
Number of participants with hypotension
defined as systolic blood pressure<90 mmHg or mean arterial pressure <50 mmHg
Measured: 30 minutes after intubation
Number of participants with hypotension
defined as systolic blood pressure<90 mmHg or mean arterial pressure <50 mmHg
Measured: 24 hours after intubation
Number of participants requiring vasopressor use
vasopressor use
Measured: 30 minutes after intubation
Number of participants requiring vasopressor use
vasopressor use
Measured: 24 hours post intubation
number of complications
examples: adrenal insufficiency, aspiration, pneumonia, acute respiratory distress syndrome, organ failure, etc.
Measured: through study completion, an average of 1 year
28-day mortality
28 day mortality
Measured: 28 days after admission
discharge disposition
examples: discharge home no services, home with services, skilled nursing facility, rehabilitation center, etc.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2020
- Study start1 Jan 2027 (estimated)
- Primary completion30 Apr 2029 (estimated)
- Study completion30 Jul 2029 (estimated)
Why it stopped: PI left institution.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for TraumaStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Irvine, University of Texas, University of Chicago, Medical College of Wisconsin
- Responsible party
- Principal investigator, Catherine Kuza, MD, University of Southern California
- Investigators
- Catherine M Kuza, MD, Principal investigator, Keck School of Medicine of the University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04291521
- Sponsor's protocol ID
- HS-20-00328
- Acronym
- ProTIM
- Status last verified
- Apr 2026
- First submitted
- 26 Feb 2020
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Banh KV, James S, Hendey GW, Snowden B, Kaups K. Single-dose etomidate for intubation in the trauma patient. J Emerg Med. 2012 Nov;43(5):e277-82. doi: 10.1016/j.jemermed.2012.02.027. Epub 2012 May 3.
PubMed 22560133Jabre P, Combes X, Lapostolle F, Dhaouadi M, Ricard-Hibon A, Vivien B, Bertrand L, Beltramini A, Gamand P, Albizzati S, Perdrizet D, Lebail G, Chollet-Xemard C, Maxime V, Brun-Buisson C, Lefrant JY, Bollaert PE, Megarbane B, Ricard JD, Anguel N, Vicaut E, Adnet F; KETASED Collaborative Study Group. Etomidate versus ketamine for rapid sequence intubation in acutely ill patients: a multicentre randomised controlled trial. Lancet. 2009 Jul 25;374(9686):293-300. doi: 10.1016/S0140-6736(09)60949-1. Epub 2009 Jul 1.
PubMed 19573904Hinkewich C, Green R. The impact of etomidate on mortality in trauma patients. Can J Anaesth. 2014 Jul;61(7):650-5. doi: 10.1007/s12630-014-0161-6. Epub 2014 Apr 11.
PubMed 24723214Hohl CM, Kelly-Smith CH, Yeung TC, Sweet DD, Doyle-Waters MM, Schulzer M. The effect of a bolus dose of etomidate on cortisol levels, mortality, and health services utilization: a systematic review. Ann Emerg Med. 2010 Aug;56(2):105-13.e5. doi: 10.1016/j.annemergmed.2010.01.030. Epub 2010 Mar 25.
PubMed 20346542McPhee LC, Badawi O, Fraser GL, Lerwick PA, Riker RR, Zuckerman IH, Franey C, Seder DB. Single-dose etomidate is not associated with increased mortality in ICU patients with sepsis: analysis of a large electronic ICU database. Crit Care Med. 2013 Mar;41(3):774-83. doi: 10.1097/CCM.0b013e318274190d.
PubMed 23318491Warner KJ, Cuschieri J, Jurkovich GJ, Bulger EM. Single-dose etomidate for rapid sequence intubation may impact outcome after severe injury. J Trauma. 2009 Jul;67(1):45-50. doi: 10.1097/TA.0b013e3181a92a70.
PubMed 19590307Upchurch CP, Grijalva CG, Russ S, Collins SP, Semler MW, Rice TW, Liu D, Ehrenfeld JM, High K, Barrett TW, McNaughton CD, Self WH. Comparison of Etomidate and Ketamine for Induction During Rapid Sequence Intubation of Adult Trauma Patients. Ann Emerg Med. 2017 Jan;69(1):24-33.e2. doi: 10.1016/j.annemergmed.2016.08.009.
PubMed 27993308Fields AM, Rosbolt MB, Cohn SM. Induction agents for intubation of the trauma patient. J Trauma. 2009 Oct;67(4):867-9. doi: 10.1097/TA.0b013e3181b021c5. No abstract available.
PubMed 19820598Baird CR, Hay AW, McKeown DW, Ray DC. Rapid sequence induction in the emergency department: induction drug and outcome of patients admitted to the intensive care unit. Emerg Med J. 2009 Aug;26(8):576-9. doi: 10.1136/emj.2008.067801.
PubMed 19625554Zettervall SL, Sirajuddin S, Akst S, Valdez C, Golshani C, Amdur RL, Sarani B, Dunne JR. Use of propofol as an induction agent in the acutely injured patient. Eur J Trauma Emerg Surg. 2015 Aug;41(4):405-11. doi: 10.1007/s00068-014-0479-3. Epub 2014 Nov 20.
PubMed 26038005Choi YF, Wong TW, Lau CC. Midazolam is more likely to cause hypotension than etomidate in emergency department rapid sequence intubation. Emerg Med J. 2004 Nov;21(6):700-2. doi: 10.1136/emj.2002.004143.
PubMed 15496697Morris C, Perris A, Klein J, Mahoney P. Anaesthesia in haemodynamically compromised emergency patients: does ketamine represent the best choice of induction agent? Anaesthesia. 2009 May;64(5):532-9. doi: 10.1111/j.1365-2044.2008.05835.x.
PubMed 19413824Miller M, Kruit N, Heldreich C, Ware S, Habig K, Reid C, Burns B. Hemodynamic Response After Rapid Sequence Induction With Ketamine in Out-of-Hospital Patients at Risk of Shock as Defined by the Shock Index. Ann Emerg Med. 2016 Aug;68(2):181-188.e2. doi: 10.1016/j.annemergmed.2016.03.041. Epub 2016 Apr 27.
PubMed 27130803Lyon RM, Perkins ZB, Chatterjee D, Lockey DJ, Russell MQ; Kent, Surrey & Sussex Air Ambulance Trust. Significant modification of traditional rapid sequence induction improves safety and effectiveness of pre-hospital trauma anaesthesia. Crit Care. 2015 Apr 1;19(1):134. doi: 10.1186/s13054-015-0872-2.
PubMed 25879683Kolenda H, Gremmelt A, Rading S, Braun U, Markakis E. Ketamine for analgosedative therapy in intensive care treatment of head-injured patients. Acta Neurochir (Wien). 1996;138(10):1193-9. doi: 10.1007/BF01809750.
PubMed 8955439
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study of Induction Medications Used in the Rapid Sequence Intubation of Trauma Patients and a Comparison of Effects on Outcomes
- ClinicalTrials.gov ID
- NCT04291521
- Acronym / sponsor ID
- ProTIM / HS-20-00328
- Conditions
- Trauma, Rapid Sequence Intubation
- Keywords
- trauma, induction medications, rapid sequence intubations, outcomes
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: PI left institution.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- University of California, Irvine, University of Texas, University of Chicago, Medical College of Wisconsin
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 30 Apr 2029 (estimated)
- Study completion
- 30 Jul 2029 (estimated)
- First posted
- 2 Mar 2020 (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.
To compare the outcomes of the use of propofol, etomidate, and ketamine as induction agents for adult trauma patients undergoing intubation within 24 hours of admission. The primary goal is to determine the ideal agent that should be used in this patient population for intubations.
Detailed description
Rationale:
Although rapid sequence intubation (RSI) is commonly used in the emergency department (ED) or operating room (OR) for trauma patients, there is not one induction medication which has been deemed the drug of choice for this particular use. There is a wide variation in induction agents used by providers performing RSIs, including propofol, ketamine, methohexital, midazolam, fentanyl, and etomidate. However, no society guidelines exist on the induction agent of choice in trauma for either hemodynamically stable or unstable patients. The purpose of this study is to compare the effects of 3 of the most commonly used induction agents (propofol, etomidate, and ketamine) for RSIs in adult trauma patients on outcomes, such as mortality, and hemodynamic status. Ultimately, the investigators would like to lay the groundwork for developing guidelines that define the ideal induction agent for trauma RSIs.
Intervention: Giving propofol, ketamine, or etomidate as the induction medication for a rapid sequence intubation in trauma patients requiring intubation within 24 hours of admission.
Objectives/Purpose: The purpose of this study is to compare the effects of 3 of the most commonly used induction agents (propofol, etomidate, and ketamine) for RSIs in adult trauma patients on outcomes such as mortality. Additionally, how each agent effects patients' hemodynamic status will be evaluated. Additional outcomes of these medications will be studied in three subsets of patients: 1. those with traumatic brain injuries, 2. elderly patients (>=65-years-old), and 3. those with a low shock index (<0.9) compared to a high shock index (>0.9). Finally, the practices and outcomes of RSIs performed in the ED versus the OR will be compared. Ultimately, the investigators would like to lay the groundwork for developing guidelines that define the ideal induction agent for trauma RSIs.
Study population: Adult trauma patients undergoing RSI within 24 hours of hospital admission
Methodology: A multicenter, prospective observational study will be performed.
Endpoints: In-hospital mortality, 28-day mortality, ICU and total hospital length of stay, complications, hypotension and vasopressor use 30 minutes and 24 hours after intubation, mechanical ventilator days, and discharge disposition
Statistic plan: Data will be entered into a password-protected online data collection tool known as RedCap, and analyzed using SAS version 9.4 (SAS Institute, Inc., Cary, NC).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult trauma patients requiring RSI | – | Drug: Ketamine, Drug: Etomidate, Drug: PropofolPatients who received an induction medication for intubation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult trauma patients requiring intubation within 24 hours of hospital admission.
Key inclusion criteria (2 listed)
- Trauma patients >=18 yo requiring intubation within 24 hours of admission in either the ED or OR
- Patients received propofol, etomidate, or ketamine for induction agent
Key exclusion criteria (3 listed)
- Patients who were intubated without induction agent medications
- Patients intubated outside of the hospital or in the field
- Patients who were intubated with an induction agent other than etomidate, ketamine, or propofol
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 |
|---|---|---|
| KetamineAlso: KetalarAdministering ketamine as an induction medication for intubating adult trauma patients within 24 hours of hospital admission. | Drug | Adult trauma patients requiring RSI |
| EtomidateAlso: AmidateAdministering etomidate as an induction medication for intubating adult trauma patients within 24 hours of hospital admission. | Drug | Adult trauma patients requiring RSI |
| PropofolAlso: DiprivanAdministering propofol as an induction medication for intubating adult trauma patients within 24 hours of hospital admission. | Drug | Adult trauma patients requiring RSI |
Primary outcome
in-hospital mortality
Time frame: through study completion, an average of 1 year
mortality
10 secondary outcomes
total hospital length of stay
Time frame: through study completion, an average of 1 year
intensive care unit length of stay
Time frame: through study completion, an average of 1 year
mechanical ventilator days
Time frame: through study completion, an average of 1 year
Number of participants with hypotension
Time frame: 30 minutes after intubation
Number of participants with hypotension
Time frame: 24 hours after intubation
Number of participants requiring vasopressor use
Time frame: 30 minutes after intubation
Number of participants requiring vasopressor use
Time frame: 24 hours post intubation
number of complications
Time frame: through study completion, an average of 1 year
28-day mortality
Time frame: 28 days after admission
discharge disposition
Time frame: through study completion, an average of 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Background: PubMed 22560133Banh KV, James S, Hendey GW, Snowden B, Kaups K. Single-dose etomidate for intubation in the trauma patient. J Emerg Med. 2012 Nov;43(5):e277-82. doi: 10.1016/j.jemermed.2012.02.027. Epub 2012 May 3.
- Background: PubMed 19573904Jabre P, Combes X, Lapostolle F, Dhaouadi M, Ricard-Hibon A, Vivien B, Bertrand L, Beltramini A, Gamand P, Albizzati S, Perdrizet D, Lebail G, Chollet-Xemard C, Maxime V, Brun-Buisson C, Lefrant JY, Bollaert PE, Megarbane B, Ricard JD, Anguel N, Vicaut E, Adnet F; KETASED Collaborative Study Group. Etomidate versus ketamine for rapid sequence intubation in acutely ill patients: a multicentre randomised controlled trial. Lancet. 2009 Jul 25;374(9686):293-300. doi: 10.1016/S0140-6736(09)60949-1. Epub 2009 Jul 1.
- Background: PubMed 24723214Hinkewich C, Green R. The impact of etomidate on mortality in trauma patients. Can J Anaesth. 2014 Jul;61(7):650-5. doi: 10.1007/s12630-014-0161-6. Epub 2014 Apr 11.
- Background: PubMed 20346542Hohl CM, Kelly-Smith CH, Yeung TC, Sweet DD, Doyle-Waters MM, Schulzer M. The effect of a bolus dose of etomidate on cortisol levels, mortality, and health services utilization: a systematic review. Ann Emerg Med. 2010 Aug;56(2):105-13.e5. doi: 10.1016/j.annemergmed.2010.01.030. Epub 2010 Mar 25.
- Background: PubMed 23318491McPhee LC, Badawi O, Fraser GL, Lerwick PA, Riker RR, Zuckerman IH, Franey C, Seder DB. Single-dose etomidate is not associated with increased mortality in ICU patients with sepsis: analysis of a large electronic ICU database. Crit Care Med. 2013 Mar;41(3):774-83. doi: 10.1097/CCM.0b013e318274190d.
- Background: PubMed 19590307Warner KJ, Cuschieri J, Jurkovich GJ, Bulger EM. Single-dose etomidate for rapid sequence intubation may impact outcome after severe injury. J Trauma. 2009 Jul;67(1):45-50. doi: 10.1097/TA.0b013e3181a92a70.
- Background: PubMed 27993308Upchurch CP, Grijalva CG, Russ S, Collins SP, Semler MW, Rice TW, Liu D, Ehrenfeld JM, High K, Barrett TW, McNaughton CD, Self WH. Comparison of Etomidate and Ketamine for Induction During Rapid Sequence Intubation of Adult Trauma Patients. Ann Emerg Med. 2017 Jan;69(1):24-33.e2. doi: 10.1016/j.annemergmed.2016.08.009.
- Background: PubMed 19820598Fields AM, Rosbolt MB, Cohn SM. Induction agents for intubation of the trauma patient. J Trauma. 2009 Oct;67(4):867-9. doi: 10.1097/TA.0b013e3181b021c5. No abstract available.
- Background: PubMed 19625554Baird CR, Hay AW, McKeown DW, Ray DC. Rapid sequence induction in the emergency department: induction drug and outcome of patients admitted to the intensive care unit. Emerg Med J. 2009 Aug;26(8):576-9. doi: 10.1136/emj.2008.067801.
- Background: PubMed 26038005Zettervall SL, Sirajuddin S, Akst S, Valdez C, Golshani C, Amdur RL, Sarani B, Dunne JR. Use of propofol as an induction agent in the acutely injured patient. Eur J Trauma Emerg Surg. 2015 Aug;41(4):405-11. doi: 10.1007/s00068-014-0479-3. Epub 2014 Nov 20.
- Background: PubMed 15496697Choi YF, Wong TW, Lau CC. Midazolam is more likely to cause hypotension than etomidate in emergency department rapid sequence intubation. Emerg Med J. 2004 Nov;21(6):700-2. doi: 10.1136/emj.2002.004143.
- Background: PubMed 19413824Morris C, Perris A, Klein J, Mahoney P. Anaesthesia in haemodynamically compromised emergency patients: does ketamine represent the best choice of induction agent? Anaesthesia. 2009 May;64(5):532-9. doi: 10.1111/j.1365-2044.2008.05835.x.
- Individual participant dataSharing planned: Undecided
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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.
Catherine M Kuza, MD principal investigator
Keck School of Medicine of the University of Southern California
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 Trauma and Rapid Sequence Intubation, run by University of Southern California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 4 May 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 United States. 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 was withdrawn before enrolling participants, so there are no results.
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?
in-hospital mortality (time frame: through study completion, an average of 1 year). 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 NCT04291521, which also lists 22 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 4 May 2026; AzTrials last refreshed its copy on 7 Nov 2026.