Septic ShockPhase 4RENOVANCT05506319
Hypotension in the Weaning From Vasopressor Drugs
A Phase 4 study testing Norepinephrine and Vasopressin in people with Septic Shock, run by Hospital Nossa Senhora da Conceicao at 1 site in Brazil.
Trial summary
Although there is consensus in the literature on hemodynamic management of septic shock in the resuscitation phase, the best way to conduct the weaning of vasopressor drugs in the stabilization phase remains open. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septic Shock
- What is being tested?
- Norepinephrine and Vasopressin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteBrazil
- Study dates
- 1 May 2022to 30 Jun 2023
- Phase
- Phase 4
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with septic shock, according to the definitions of SEPSIS - 3: septic and hypotensive patients, demanding use of vasoactive drug and lactate greater than 2 mmol/L (18 mg/dL).
- Patients admitted to the intensive care unit.
- Patients in need of associated use of norepinephrine and vasopressin.
Who cannot join
- Patients in whom discontinuation of norepinephrine or vasopressin has been given by decision of the assistant team, from a perspective of prioritizing palliative care.
- Patients using a combination of a third drug, with the effect of predominantly vasopressor - adrenaline.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital Nossa Senhora da Conceicao
Porto Alegre, Rio Grande do Sul, 91350-200
About this study
Official title: Incidence of Hypotension in the Weaning From Vasopressor Drugs
Although there is consensus in the literature on hemodynamic management of septic shock in the resuscitation phase, the best way to conduct the weaning of vasopressor drugs in the stabilization phase remains open. The present study aims to study the incidence of hypotension in the weaning phase of vasopressor drugs- norepinephrine and vasopressin.
Read the detailed description
A randomized, open-case clinical trial with 2 arms will be conducted: initial suspension of norepinephrine (norepinephrine group) versus initial vasopressin (vasopressin group).
The selection of patients who will participate in the study will be for convenience. The randomization of the patients will be done by opaque envelopes 1:1, grouped into blocks, generated by random numbers.
The study will be carried out in the intensive care unit of a tertiary hospital in Southern Brazil, taking into account the clinical and surgical patients. In the intensive care unit, after randomization, patients will be identified by posters, attached to the bed. The titration of vasoactive drugs will be criterion of the assistant team.
- Conditions
- Septic Shock
- Being tested
- Norepinephrine, Vasopressin
- Keywords
- vasoconstrictor agents, sepsis, critical care, vasopressin
- Medical subject headings
- Shock, Septic, Sepsis, Diabetes Insipidus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NorepinephrineOther
The patients will be randomized for the initial suspension of norepinephrine (norepinephrine group).
VasopressinOther
The patients will be randomized for the initial suspension of vasopressin (vasopressin group).
| Study group | Role | What they receive |
|---|---|---|
| norepinephrine group | Experimental | Initial suspension of norepinephrine. Receives: Other: Norepinephrine |
| vasopressin group | Experimental | Initial suspension of vasopressin. Receives: Other: Vasopressin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of hypotension
Evaluation of the incidence of hypotension in the first 24 hours after discontinuation of one of the vasoactive drugs: norepinephrine or vasopressin. It is defined as hypotension the drop in mean blood pressure below 65 mmHg, triggering one or more of the following measures: a) administration of crystalloid or colloid aliquot, b) dose increase of the remaining vasoactive drug or c) re-establishment of the drug vasoactive paused.
Measured: The first 24 hours after the start of reduction of one of the vasopressors.
Secondary outcomes (5)
Mortality
Evaluation of the mortality in first 28 days after discontinuation of one of the vasoactive drugs.
Measured: Mortality in a 28-day follow-up, from the beginning of the reduction of one of the vasopressors.
Length of stay in intensive care unit
Evaluation of the length of stay in intensive care unit.
Measured: In a 28-day follow-up, from the beginning of reduction of one of the vasopressors.
Time of use of the vasoactive drugs
Quantify the time spent using vasoactive drugs after the removal of the first drug (norepinephrine or vasopressin) in days.
Measured: Follow-up of up to 7 days, from the beginning of reduction of one of the vasopressors.
Incidence of arrhythmias
Quantify the incidence of arrhythmias with hemodynamic repercussions in 24 hours after withdrawal of the first drug (norepinephrine or vasopressin). This group includes events in which hemodynamic worsening required electrical or chemical cardioversion.
Measured: The first 24 hours after the start of reduction of one of the vasopressors.
Incidence of hemodialysis
Quantify the incidence of hemodialysis, independent of dialysis modality, excluding patients on dialysis chronic.
Measured: The first 72 hours after the start of reduction of one of the vasopressors.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2022
- Study start1 May 2022
- Primary completion1 Dec 2022
- Study completion30 Jun 2023
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 Septic ShockStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized, parallel, open-case clinical trial.
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Nossa Senhora da Conceicao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cassio Mallmann, MD, Principal investigator, casmallmann@yahoo.com.br
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05506319
- Sponsor's protocol ID
- 57213022.0.0000.5530
- Acronym
- RENOVA
- Status last verified
- Mar 2025
- First submitted
- 25 Jul 2022
- Last updated
- 14 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Landry DW, Oliver JA. The pathogenesis of vasodilatory shock. N Engl J Med. 2001 Aug 23;345(8):588-95. doi: 10.1056/NEJMra002709. No abstract available.
PubMed 11529214Evans L, Rhodes A, Alhazzani W, Antonelli M, Coopersmith CM, French C, Machado FR, Mcintyre L, Ostermann M, Prescott HC, Schorr C, Simpson S, Wiersinga WJ, Alshamsi F, Angus DC, Arabi Y, Azevedo L, Beale R, Beilman G, Belley-Cote E, Burry L, Cecconi M, Centofanti J, Coz Yataco A, De Waele J, Dellinger RP, Doi K, Du B, Estenssoro E, Ferrer R, Gomersall C, Hodgson C, Hylander Moller M, 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. Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock 2021. Crit Care Med. 2021 Nov 1;49(11):e1063-e1143. doi: 10.1097/CCM.0000000000005337. No abstract available.
PubMed 34605781Russell JA, Walley KR, Singer J, Gordon AC, Hebert PC, Cooper DJ, Holmes CL, Mehta S, Granton JT, Storms MM, Cook DJ, Presneill JJ, Ayers D; VASST Investigators. Vasopressin versus norepinephrine infusion in patients with septic shock. N Engl J Med. 2008 Feb 28;358(9):877-87. doi: 10.1056/NEJMoa067373.
PubMed 18305265Der-Nigoghossian C, Hammond DA, Ammar MA. Narrative Review of Controversies Involving Vasopressin Use in Septic Shock and Practical Considerations. Ann Pharmacother. 2020 Jul;54(7):706-714. doi: 10.1177/1060028020901521. Epub 2020 Jan 20.
PubMed 31958982Russell JA, Fjell C, Hsu JL, Lee T, Boyd J, Thair S, Singer J, Patterson AJ, Walley KR. Vasopressin compared with norepinephrine augments the decline of plasma cytokine levels in septic shock. Am J Respir Crit Care Med. 2013 Aug 1;188(3):356-64. doi: 10.1164/rccm.201302-0355OC.
PubMed 23796235Gordon AC, Wang N, Walley KR, Ashby D, Russell JA. The cardiopulmonary effects of vasopressin compared with norepinephrine in septic shock. Chest. 2012 Sep;142(3):593-605. doi: 10.1378/chest.11-2604.
PubMed 22518026Nascente APM, Freitas FGR, Bakker J, Bafi AT, Ladeira RT, Azevedo LCP, Lima A, Machado FR. Microcirculation improvement after short-term infusion of vasopressin in septic shock is dependent on noradrenaline. Clinics (Sao Paulo). 2017 Dec;72(12):750-757. doi: 10.6061/clinics/2017(12)06.
PubMed 29319721Yin A, Yamada A, Stam WB, van Hasselt JGC, van der Graaf PH. Quantitative systems pharmacology analysis of drug combination and scaling to humans: the interaction between noradrenaline and vasopressin in vasoconstriction. Br J Pharmacol. 2018 Aug;175(16):3394-3406. doi: 10.1111/bph.14385. Epub 2018 Jul 10.
PubMed 29859008Stolk RF, van der Poll T, Angus DC, van der Hoeven JG, Pickkers P, Kox M. Potentially Inadvertent Immunomodulation: Norepinephrine Use in Sepsis. Am J Respir Crit Care Med. 2016 Sep 1;194(5):550-8. doi: 10.1164/rccm.201604-0862CP.
PubMed 27398737Hotchkiss RS, Karl IE. The pathophysiology and treatment of sepsis. N Engl J Med. 2003 Jan 9;348(2):138-50. doi: 10.1056/NEJMra021333. No abstract available.
PubMed 12519925Gordon AC, Mason AJ, Thirunavukkarasu N, Perkins GD, Cecconi M, Cepkova M, Pogson DG, Aya HD, Anjum A, Frazier GJ, Santhakumaran S, Ashby D, Brett SJ; VANISH Investigators. Effect of Early Vasopressin vs Norepinephrine on Kidney Failure in Patients With Septic Shock: The VANISH Randomized Clinical Trial. JAMA. 2016 Aug 2;316(5):509-18. doi: 10.1001/jama.2016.10485.
PubMed 27483065Smith SE, Newsome AS, Tackett RL. Prescribing of Pressor Agents in Septic Shock: A Survey of Critical Care Pharmacists. J Pharm Technol. 2019 Oct;35(5):187-193. doi: 10.1177/8755122519846164. Epub 2019 May 8.
PubMed 34752520Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287.
PubMed 26903338Bauer SR, Aloi JJ, Ahrens CL, Yeh JY, Culver DA, Reddy AJ. Discontinuation of vasopressin before norepinephrine increases the incidence of hypotension in patients recovering from septic shock: a retrospective cohort study. J Crit Care. 2010 Jun;25(2):362.e7-362.e11. doi: 10.1016/j.jcrc.2009.10.005.
PubMed 19926252Hammond DA, McCain K, Painter JT, Clem OA, Cullen J, Brotherton AL, Chopra D, Meena N. Discontinuation of Vasopressin Before Norepinephrine in the Recovery Phase of Septic Shock. J Intensive Care Med. 2019 Oct;34(10):805-810. doi: 10.1177/0885066617714209. Epub 2017 Jun 15.
PubMed 28618919
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Hypotension in the Weaning From Vasopressor Drugs
- ClinicalTrials.gov ID
- NCT05506319
- Acronym / sponsor ID
- RENOVA / 57213022.0.0000.5530
- Conditions
- Septic Shock
- Keywords
- vasoconstrictor agents, sepsis, critical care, vasopressin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Hospital Nossa Senhora da ConceicaoUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 18 Aug 2022 (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.
Although there is consensus in the literature on hemodynamic management of septic shock in the resuscitation phase, the best way to conduct the weaning of vasopressor drugs in the stabilization phase remains open. The present study aims to study the incidence of hypotension in the weaning phase of vasopressor drugs- norepinephrine and vasopressin.
Detailed description
A randomized, open-case clinical trial with 2 arms will be conducted: initial suspension of norepinephrine (norepinephrine group) versus initial vasopressin (vasopressin group).
The selection of patients who will participate in the study will be for convenience. The randomization of the patients will be done by opaque envelopes 1:1, grouped into blocks, generated by random numbers.
The study will be carried out in the intensive care unit of a tertiary hospital in Southern Brazil, taking into account the clinical and surgical patients. In the intensive care unit, after randomization, patients will be identified by posters, attached to the bed. The titration of vasoactive drugs will be criterion of the assistant team.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A randomized, parallel, open-case clinical trial.
| Arm | Type | Receives |
|---|---|---|
| norepinephrine group | Experimental | Other: NorepinephrineInitial suspension of norepinephrine. |
| vasopressin group | Experimental | Other: VasopressinInitial suspension of vasopressin. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with septic shock, according to the definitions of SEPSIS - 3: septic and hypotensive patients, demanding use of vasoactive drug and lactate greater than 2 mmol/L (18 mg/dL).
- Patients admitted to the intensive care unit.
- Patients in need of associated use of norepinephrine and vasopressin.
Key exclusion criteria (2 listed)
- Patients in whom discontinuation of norepinephrine or vasopressin has been given by decision of the assistant team, from a perspective of prioritizing palliative care.
- Patients using a combination of a third drug, with the effect of predominantly vasopressor - adrenaline.
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 |
|---|---|---|
| NorepinephrineThe patients will be randomized for the initial suspension of norepinephrine (norepinephrine group). | Other | norepinephrine group |
| VasopressinThe patients will be randomized for the initial suspension of vasopressin (vasopressin group). | Other | vasopressin group |
Primary outcome
Incidence of hypotension
Time frame: The first 24 hours after the start of reduction of one of the vasopressors.
Evaluation of the incidence of hypotension in the first 24 hours after discontinuation of one of the vasoactive drugs: norepinephrine or vasopressin. It is defined as hypotension the drop in mean blood pressure below 65 mmHg, triggering one or more of the following measures: a) administration of crystalloid or colloid aliquot, b) dose increase of the remaining vasoactive drug or c) re-establishment of the drug vasoactive paused.
5 secondary outcomes
Mortality
Time frame: Mortality in a 28-day follow-up, from the beginning of the reduction of one of the vasopressors.
Length of stay in intensive care unit
Time frame: In a 28-day follow-up, from the beginning of reduction of one of the vasopressors.
Time of use of the vasoactive drugs
Time frame: Follow-up of up to 7 days, from the beginning of reduction of one of the vasopressors.
Incidence of arrhythmias
Time frame: The first 24 hours after the start of reduction of one of the vasopressors.
Incidence of hemodialysis
Time frame: The first 72 hours after the start of reduction of one of the vasopressors.
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 14 Mar 2025.
- Results publication: PubMed 11529214Landry DW, Oliver JA. The pathogenesis of vasodilatory shock. N Engl J Med. 2001 Aug 23;345(8):588-95. doi: 10.1056/NEJMra002709. No abstract available.
- Results publication: PubMed 34605781Evans L, Rhodes A, Alhazzani W, Antonelli M, Coopersmith CM, French C, Machado FR, Mcintyre L, Ostermann M, Prescott HC, Schorr C, Simpson S, Wiersinga WJ, Alshamsi F, Angus DC, Arabi Y, Azevedo L, Beale R, Beilman G, Belley-Cote E, Burry L, Cecconi M, Centofanti J, Coz Yataco A, De Waele J, Dellinger RP, Doi K, Du B, Estenssoro E, Ferrer R, Gomersall C, Hodgson C, Hylander Moller M, 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. Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock 2021. Crit Care Med. 2021 Nov 1;49(11):e1063-e1143. doi: 10.1097/CCM.0000000000005337. No abstract available.
- Results publication: PubMed 18305265Russell JA, Walley KR, Singer J, Gordon AC, Hebert PC, Cooper DJ, Holmes CL, Mehta S, Granton JT, Storms MM, Cook DJ, Presneill JJ, Ayers D; VASST Investigators. Vasopressin versus norepinephrine infusion in patients with septic shock. N Engl J Med. 2008 Feb 28;358(9):877-87. doi: 10.1056/NEJMoa067373.
- Results publication: PubMed 31958982Der-Nigoghossian C, Hammond DA, Ammar MA. Narrative Review of Controversies Involving Vasopressin Use in Septic Shock and Practical Considerations. Ann Pharmacother. 2020 Jul;54(7):706-714. doi: 10.1177/1060028020901521. Epub 2020 Jan 20.
- Results publication: PubMed 23796235Russell JA, Fjell C, Hsu JL, Lee T, Boyd J, Thair S, Singer J, Patterson AJ, Walley KR. Vasopressin compared with norepinephrine augments the decline of plasma cytokine levels in septic shock. Am J Respir Crit Care Med. 2013 Aug 1;188(3):356-64. doi: 10.1164/rccm.201302-0355OC.
- Results publication: PubMed 22518026Gordon AC, Wang N, Walley KR, Ashby D, Russell JA. The cardiopulmonary effects of vasopressin compared with norepinephrine in septic shock. Chest. 2012 Sep;142(3):593-605. doi: 10.1378/chest.11-2604.
- Results publication: PubMed 29319721Nascente APM, Freitas FGR, Bakker J, Bafi AT, Ladeira RT, Azevedo LCP, Lima A, Machado FR. Microcirculation improvement after short-term infusion of vasopressin in septic shock is dependent on noradrenaline. Clinics (Sao Paulo). 2017 Dec;72(12):750-757. doi: 10.6061/clinics/2017(12)06.
- Results publication: PubMed 29859008Yin A, Yamada A, Stam WB, van Hasselt JGC, van der Graaf PH. Quantitative systems pharmacology analysis of drug combination and scaling to humans: the interaction between noradrenaline and vasopressin in vasoconstriction. Br J Pharmacol. 2018 Aug;175(16):3394-3406. doi: 10.1111/bph.14385. Epub 2018 Jul 10.
- Results publication: PubMed 27398737Stolk RF, van der Poll T, Angus DC, van der Hoeven JG, Pickkers P, Kox M. Potentially Inadvertent Immunomodulation: Norepinephrine Use in Sepsis. Am J Respir Crit Care Med. 2016 Sep 1;194(5):550-8. doi: 10.1164/rccm.201604-0862CP.
- Results publication: PubMed 12519925Hotchkiss RS, Karl IE. The pathophysiology and treatment of sepsis. N Engl J Med. 2003 Jan 9;348(2):138-50. doi: 10.1056/NEJMra021333. No abstract available.
- Results publication: PubMed 27483065Gordon AC, Mason AJ, Thirunavukkarasu N, Perkins GD, Cecconi M, Cepkova M, Pogson DG, Aya HD, Anjum A, Frazier GJ, Santhakumaran S, Ashby D, Brett SJ; VANISH Investigators. Effect of Early Vasopressin vs Norepinephrine on Kidney Failure in Patients With Septic Shock: The VANISH Randomized Clinical Trial. JAMA. 2016 Aug 2;316(5):509-18. doi: 10.1001/jama.2016.10485.
- Results publication: PubMed 34752520Smith SE, Newsome AS, Tackett RL. Prescribing of Pressor Agents in Septic Shock: A Survey of Critical Care Pharmacists. J Pharm Technol. 2019 Oct;35(5):187-193. doi: 10.1177/8755122519846164. Epub 2019 May 8.
- Borges RB, et al. Power and Sample Size for Health Researchers: uma ferramenta para cálculo de tamanho amostral e poder do teste voltado a pesquisadores da área da saúde.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Sepsis
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.
Cassio Mallmann, MD principal investigator
casmallmann@yahoo.com.br
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Norepinephrine and Vasopressin in people with Septic Shock, run by Hospital Nossa Senhora da Conceicao at 1 site in Brazil.
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 3 inclusion and 2 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 14 Mar 2025. 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 Brazil. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Incidence of hypotension (time frame: The first 24 hours after the start of reduction of one of the vasopressors.). 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 NCT05506319, 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 14 Mar 2025.