Septic ShockPhase 3WAVESNCT07067866
Weaning Approaches for Vasopressin in Sepsis
A Phase 3 study testing Titrated weaning of vasopressin. and Abrupt weaning of vasopressin. in people with Septic Shock, run by Hospital Nossa Senhora da Conceicao at 1 site in Brazil.
Trial summary
In this study, we aim to evaluate the incidence of hypotension during vasopressin weaning by comparing two methods - titrated reduction versus abrupt withdrawal - through the conduct of a randomized clinical trial. 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?
- Titrated weaning of vasopressin. and Abrupt weaning of vasopressin.
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Oct 2025to 1 Oct 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- Age over 18 years
- Admitted to the Intensive Care Unit
- Patients with vasopressor dependent sepsis
- Receiving combined norepinephrine and vasopressin therapy
Who cannot join
- Withdrawal/reduction of vasopressin related to a plan of treatment limitation or palliative care
- Withdrawal/reduction of vasopressin associated with the initiation of adrenaline or any other vasopressor
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Hospital Nossa Senhora da Conceição
Porto Alegre, Rio Grande do Sul, 91350200
About this study
Official title: Weaning Approaches for Vasopressin in Sepsis - a Randomized Controlled Trial of Titrated Versus Abrupt Discontinuation During Stabilization of Septic Shock - WAVES Trial
In this study, we aim to evaluate the incidence of hypotension during vasopressin weaning by comparing two methods - titrated reduction versus abrupt withdrawal - through the conduct of a randomized clinical trial.
Read the detailed description
Catecholamine infusions are usually tapered gradually in a titrated manner. However, little is known about how to manage adjunctive therapies such as vasopressin. While catecholamines have a short half-life (2-3 minutes), vasopressin's half-life ranges from 10 to 20 minutes. Although endogenous vasopressin levels are depleted in the early phase of shock, they are restored during recovery. Given its pharmacokinetic profile and the endogenous dynamics across different phases of shock, the optimal approach to vasopressin withdrawal - whether titrated or abrupt - remains unclear.
In 2021, a study was published comparing abrupt versus gradual vasopressin discontinuation. This was a retrospective observational study including 1,318 patients. Using ICU length of stay as the primary outcome, no significant difference was observed between groups (abrupt discontinuation: 7.9 days; gradual discontinuation: 7.3 days; p = 0.6). Similarly, there was no difference in the incidence of clinically significant hypotension (abrupt: 39.7%; gradual: 41.7%; p = 0.53). However, when stratifying patients based on whether catecholamine infusions were still ongoing at the time of vasopressin discontinuation, the results reversed in terms of ICU stay (abrupt: 9.2 days; gradual: 7.6 days), although this difference was not statistically significant (p = 0.24). In 2023, another retrospective observational study was published comparing abrupt versus gradual vasopressin withdrawal, including 74 patients. No difference was found in the incidence of clinically significant hypotension (abrupt: 57.1%; gradual: 52.3%; p = 0.68), nor in ICU length of stay. It is important to note, however, that in this cohort only patients who had already discontinued catecholamines prior to vasopressin withdrawal were included.
- Conditions
- Septic Shock
- Being tested
- Titrated weaning of vasopressin., Abrupt weaning of vasopressin.
- Keywords
- vasopressin, septic shock, vasopressor weaning
- Medical subject headings
- Shock, Septic, Diabetes Insipidus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Titrated weaning of vasopressin.Other
The titrated group will follow the vasopressin weaning protocol used in the DOVSS study (reduction of 0.01 U/min per hour).
Abrupt weaning of vasopressin.Other
The abrupt group will discontinue the vasopressin infusion at the time of randomization, without dose titration.
| Study group | Role | What they receive |
|---|---|---|
| Titrated group | Experimental | The titrated group will follow the vasopressin weaning protocol used in the DOVSS study (reduction of 0.01 U/min per hour). Receives: Other: Titrated weaning of vasopressin. |
| Abrupt group | Active comparator | The abrupt group will discontinue the vasopressin infusion at the time of randomization, without dose titration. Receives: Other: Abrupt weaning of vasopressin. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypotension within the first 24 hours
Incidence of hypotension with clinical repercussions within the first 24 hours after titrated reduction or abrupt withdrawal of vasopressin.
Definition of hypotension with clinical repercussions:
mean arterial pressure < 60 mmHg, leading to:
- administration of crystalloid/colloid bolus and/or
- increase in norepinephrine dose and/or
- reinitiation or increase in vasopressin dose.
Measured: 24 hours
Secondary outcomes (9)
Hypotension stratified according to vasopressin duration
Incidence of hypotension with clinical repercussions within the first 24 hours after titrated reduction or abrupt withdrawal of vasopressin, stratified according to vasopressin duration:
< 48 hours
≥ 48 hours
Definition of hypotension with clinical repercussions:
mean arterial pressure < 60 mmHg, leading to:
- administration of crystalloid/colloid bolus and/or
- increase in norepinephrine dose and/or
- reinitiation or increase in vasopressin dose.
Measured: 24 hours
Hypotension within the first hour
Incidence of hypotension with clinical repercussions within the first hour after titrated reduction or abrupt withdrawal of vasopressin.
Definition of hypotension with clinical repercussions:
mean arterial pressure < 60 mmHg, leading to:
- administration of crystalloid/colloid bolus and/or
- increase in norepinephrine dose and/or
- reinitiation or increase in vasopressin dose.
Measured: First hour
Vasopressor-free days
Number of days a patient is alive and free of vasopressor between randomization and day 7. Non-survivors will be considered to have zero vasopressor-free days.
Measured: 7 days
Vasopressin-free days
Number of days a patient is alive and free of vasopressin between randomization and day 7. Non-survivors will be considered to have zero vasopressin-free days.
Measured: 7 days
Renal replacement therapy
Initiation of hemodialysis between randomization and day 7, excluding chronic dialysis patients.
Measured: 7 days
Cardiac arrhythmias
Incidence of arrhythmias with hemodynamic consequences between randomization and day 7, defined as hemodynamic deterioration requiring electrical or chemical cardioversion.
Measured: 7 days
ICU-free days
Number of days a patient is alive and outside the ICU between randomization and day 28. Non-survivors will be considered to have zero ICU-free days.
Measured: 28 days
Ischemic events
Occurrence of mesenteric ischemia, ischemic stroke, digital ischemia and acute coronary syndrome between randomization and day 28.
Measured: 28 days
All-cause mortality
All-cause mortality within 28 days after randomization.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2025
- Study start1 Oct 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion1 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Nossa Senhora da Conceicao
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cássio Mallmann, Hospital Nossa Senhora da Conceicao
- Investigators
- Cássio Mallmann, Critical Care Physician, MS, Principal investigator, Hospital Nossa Senhora da Conceicao
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07067866
- Sponsor's protocol ID
- CAAE: 83246724.1.0000.5530
- Acronym
- WAVES
- Status last verified
- Dec 2025
- First submitted
- 6 Jul 2025
- Last updated
- 2 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Murata J, Buckley M, Lehn J, Agarwal SK, Stevenson B, Martinez B, MacLaren R. Incidence of Hypotension Associated With Two Different Vasopressin Discontinuation Strategies in the Recovery Phase of Septic Shock. J Pharm Pract. 2023 Aug;36(4):830-838. doi: 10.1177/08971900221078270. Epub 2022 Mar 25.
PubMed 35331049Lam SW, Sacha GL, Duggal A, Reddy AJ, Bauer SR. Abrupt Discontinuation Versus Down-Titration of Vasopressin in Patients Recovering from Septic Shock. Shock. 2021 Feb 1;55(2):210-214. doi: 10.1097/SHK.0000000000001609.
PubMed 32842024Der-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 31958982Jeon K, Song JU, Chung CR, Yang JH, Suh GY. Incidence of hypotension according to the discontinuation order of vasopressors in the management of septic shock: a prospective randomized trial (DOVSS). Crit Care. 2018 May 21;22(1):131. doi: 10.1186/s13054-018-2034-9.
PubMed 29784057Sacha GL, Lam SW, Duggal A, Torbic H, Reddy AJ, Bauer SR. Hypotension Risk Based on Vasoactive Agent Discontinuation Order in Patients in the Recovery Phase of Septic Shock. Pharmacotherapy. 2018 Mar;38(3):319-326. doi: 10.1002/phar.2082. Epub 2018 Feb 8.
PubMed 29328496Hammond DA, Painter JT, Meena N. Incidence of Clinically Significant Hypotension Stratified by Vasopressin Duration. J Intensive Care Med. 2019 Jan;34(1):77-78. doi: 10.1177/0885066617745809. No abstract available.
PubMed 30798676Landry DW, Levin HR, Gallant EM, Ashton RC Jr, Seo S, D'Alessandro D, Oz MC, Oliver JA. Vasopressin deficiency contributes to the vasodilation of septic shock. Circulation. 1997 Mar 4;95(5):1122-5. doi: 10.1161/01.cir.95.5.1122.
PubMed 9054839Bissell BD, Magee C, Moran P, Bastin MLT, Flannery AH. Hemodynamic Instability Secondary to Vasopressin Withdrawal in Septic Shock. J Intensive Care Med. 2019 Sep;34(9):761-765. doi: 10.1177/0885066617716396. Epub 2017 Jul 28.
PubMed 28750598Bauer 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 19926252De Backer D, Deutschman CS, Hellman J, Myatra SN, Ostermann M, Prescott HC, Talmor D, Antonelli M, Pontes Azevedo LC, Bauer SR, Kissoon N, Loeches IM, Nunnally M, Tissieres P, Vieillard-Baron A, Coopersmith CM; Surviving Sepsis Campaign Research Committee. Surviving Sepsis Campaign Research Priorities 2023. Crit Care Med. 2024 Feb 1;52(2):268-296. doi: 10.1097/CCM.0000000000006135. Epub 2024 Jan 19.
PubMed 38240508Teboul JL, Duranteau J, Russell JA. Intensive care medicine in 2050: vasopressors in sepsis. Intensive Care Med. 2018 Jul;44(7):1130-1132. doi: 10.1007/s00134-017-4909-7. Epub 2017 Aug 31. No abstract available.
PubMed 28861671Leone M, Einav S, Antonucci E, Depret F, Lakbar I, Martin-Loeches I, Wieruszewski PM, Myatra SN, Khanna AK. Multimodal strategy to counteract vasodilation in septic shock. Anaesth Crit Care Pain Med. 2023 Jun;42(3):101193. doi: 10.1016/j.accpm.2023.101193. Epub 2023 Jan 5.
PubMed 36621622Hammond DA, Rech MA, Daley MJ, Devlin JW, Hodge EK, Kooda KJ, Lat I, Personett HA, Roberts R, Sacha G, Stollings JL, Swanson JM, Bauer SR. Perceptions regarding vasopressin use and practices in septic shock, and cost containment strategies. J Am Coll Clin Pharm. 2019 Jun;2(3):257-267. doi: 10.1002/jac5.1079. Epub 2019 Jan 24.
PubMed 38213315
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weaning Approaches for Vasopressin in Sepsis - a Randomized Controlled Trial of Titrated Versus Abrupt Discontinuation During Stabilization of Septic Shock - WAVES Trial
- ClinicalTrials.gov ID
- NCT07067866
- Acronym / sponsor ID
- WAVES / CAAE: 83246724.1.0000.5530
- Conditions
- Septic Shock
- Keywords
- vasopressin, septic shock, vasopressor weaning
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Hospital Nossa Senhora da ConceicaoUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 1 Oct 2028 (estimated)
- First posted
- 16 Jul 2025 (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.
In this study, we aim to evaluate the incidence of hypotension during vasopressin weaning by comparing two methods - titrated reduction versus abrupt withdrawal - through the conduct of a randomized clinical trial.
Detailed description
Catecholamine infusions are usually tapered gradually in a titrated manner. However, little is known about how to manage adjunctive therapies such as vasopressin. While catecholamines have a short half-life (2-3 minutes), vasopressin's half-life ranges from 10 to 20 minutes. Although endogenous vasopressin levels are depleted in the early phase of shock, they are restored during recovery. Given its pharmacokinetic profile and the endogenous dynamics across different phases of shock, the optimal approach to vasopressin withdrawal - whether titrated or abrupt - remains unclear.
In 2021, a study was published comparing abrupt versus gradual vasopressin discontinuation. This was a retrospective observational study including 1,318 patients. Using ICU length of stay as the primary outcome, no significant difference was observed between groups (abrupt discontinuation: 7.9 days; gradual discontinuation: 7.3 days; p = 0.6). Similarly, there was no difference in the incidence of clinically significant hypotension (abrupt: 39.7%; gradual: 41.7%; p = 0.53). However, when stratifying patients based on whether catecholamine infusions were still ongoing at the time of vasopressin discontinuation, the results reversed in terms of ICU stay (abrupt: 9.2 days; gradual: 7.6 days), although this difference was not statistically significant (p = 0.24). In 2023, another retrospective observational study was published comparing abrupt versus gradual vasopressin withdrawal, including 74 patients. No difference was found in the incidence of clinically significant hypotension (abrupt: 57.1%; gradual: 52.3%; p = 0.68), nor in ICU length of stay. It is important to note, however, that in this cohort only patients who had already discontinued catecholamines prior to vasopressin withdrawal were included.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Titrated group | Experimental | Other: Titrated weaning of vasopressin.The titrated group will follow the vasopressin weaning protocol used in the DOVSS study (reduction of 0.01 U/min per hour). |
| Abrupt group | Active comparator | Other: Abrupt weaning of vasopressin.The abrupt group will discontinue the vasopressin infusion at the time of randomization, without dose titration. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age over 18 years
- Admitted to the Intensive Care Unit
- Patients with vasopressor dependent sepsis
- Receiving combined norepinephrine and vasopressin therapy
Key exclusion criteria (2 listed)
- Withdrawal/reduction of vasopressin related to a plan of treatment limitation or palliative care
- Withdrawal/reduction of vasopressin associated with the initiation of adrenaline or any other vasopressor
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 |
|---|---|---|
| Titrated weaning of vasopressin.The titrated group will follow the vasopressin weaning protocol used in the DOVSS study (reduction of 0.01 U/min per hour). | Other | Titrated group |
| Abrupt weaning of vasopressin.The abrupt group will discontinue the vasopressin infusion at the time of randomization, without dose titration. | Other | Abrupt group |
Primary outcome
Hypotension within the first 24 hours
Time frame: 24 hours
Incidence of hypotension with clinical repercussions within the first 24 hours after titrated reduction or abrupt withdrawal of vasopressin. Definition of hypotension with clinical repercussions: mean arterial pressure < 60 mmHg, leading to: * administration of crystalloid/colloid bolus and/or * increase in norepinephrine dose and/or * reinitiation or increase in vasopressin dose.
9 secondary outcomes
Hypotension stratified according to vasopressin duration
Time frame: 24 hours
Hypotension within the first hour
Time frame: First hour
Vasopressor-free days
Time frame: 7 days
Vasopressin-free days
Time frame: 7 days
Renal replacement therapy
Time frame: 7 days
Cardiac arrhythmias
Time frame: 7 days
ICU-free days
Time frame: 28 days
Ischemic events
Time frame: 28 days
All-cause mortality
Time frame: 28 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2026.
- Results publication: PubMed 35331049Murata J, Buckley M, Lehn J, Agarwal SK, Stevenson B, Martinez B, MacLaren R. Incidence of Hypotension Associated With Two Different Vasopressin Discontinuation Strategies in the Recovery Phase of Septic Shock. J Pharm Pract. 2023 Aug;36(4):830-838. doi: 10.1177/08971900221078270. Epub 2022 Mar 25.
- Results publication: PubMed 32842024Lam SW, Sacha GL, Duggal A, Reddy AJ, Bauer SR. Abrupt Discontinuation Versus Down-Titration of Vasopressin in Patients Recovering from Septic Shock. Shock. 2021 Feb 1;55(2):210-214. doi: 10.1097/SHK.0000000000001609.
- 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 29784057Jeon K, Song JU, Chung CR, Yang JH, Suh GY. Incidence of hypotension according to the discontinuation order of vasopressors in the management of septic shock: a prospective randomized trial (DOVSS). Crit Care. 2018 May 21;22(1):131. doi: 10.1186/s13054-018-2034-9.
- Results publication: PubMed 29328496Sacha GL, Lam SW, Duggal A, Torbic H, Reddy AJ, Bauer SR. Hypotension Risk Based on Vasoactive Agent Discontinuation Order in Patients in the Recovery Phase of Septic Shock. Pharmacotherapy. 2018 Mar;38(3):319-326. doi: 10.1002/phar.2082. Epub 2018 Feb 8.
- Results publication: PubMed 30798676Hammond DA, Painter JT, Meena N. Incidence of Clinically Significant Hypotension Stratified by Vasopressin Duration. J Intensive Care Med. 2019 Jan;34(1):77-78. doi: 10.1177/0885066617745809. No abstract available.
- Results publication: PubMed 9054839Landry DW, Levin HR, Gallant EM, Ashton RC Jr, Seo S, D'Alessandro D, Oz MC, Oliver JA. Vasopressin deficiency contributes to the vasodilation of septic shock. Circulation. 1997 Mar 4;95(5):1122-5. doi: 10.1161/01.cir.95.5.1122.
- Results publication: PubMed 28750598Bissell BD, Magee C, Moran P, Bastin MLT, Flannery AH. Hemodynamic Instability Secondary to Vasopressin Withdrawal in Septic Shock. J Intensive Care Med. 2019 Sep;34(9):761-765. doi: 10.1177/0885066617716396. Epub 2017 Jul 28.
- Results publication: PubMed 19926252Bauer 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.
- Results publication: PubMed 38240508De Backer D, Deutschman CS, Hellman J, Myatra SN, Ostermann M, Prescott HC, Talmor D, Antonelli M, Pontes Azevedo LC, Bauer SR, Kissoon N, Loeches IM, Nunnally M, Tissieres P, Vieillard-Baron A, Coopersmith CM; Surviving Sepsis Campaign Research Committee. Surviving Sepsis Campaign Research Priorities 2023. Crit Care Med. 2024 Feb 1;52(2):268-296. doi: 10.1097/CCM.0000000000006135. Epub 2024 Jan 19.
- Results publication: PubMed 28861671Teboul JL, Duranteau J, Russell JA. Intensive care medicine in 2050: vasopressors in sepsis. Intensive Care Med. 2018 Jul;44(7):1130-1132. doi: 10.1007/s00134-017-4909-7. Epub 2017 Aug 31. No abstract available.
- Results publication: PubMed 36621622Leone M, Einav S, Antonucci E, Depret F, Lakbar I, Martin-Loeches I, Wieruszewski PM, Myatra SN, Khanna AK. Multimodal strategy to counteract vasodilation in septic shock. Anaesth Crit Care Pain Med. 2023 Jun;42(3):101193. doi: 10.1016/j.accpm.2023.101193. Epub 2023 Jan 5.
- 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.
Cássio Mallmann, Critical Care Physician, MS principal investigator
Hospital Nossa Senhora da Conceicao
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Titrated weaning of vasopressin. and Abrupt weaning of 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 4 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: looking for participants now, as of the sponsor's last update on 2 Jan 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 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wagner Luis Nedel, Critical Care Physician, PhD (55 51 999547554, wagnernedel@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hypotension within the first 24 hours (time frame: 24 hours). 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 NCT07067866, which also lists 13 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 2 Jan 2026.