A Phase 3 interventional study of Titrated weaning of vasopressin. and Abrupt weaning of vasopressin. in Septic Shock, sponsored by Hospital Nossa Senhora da Conceicao. Recruiting at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-02.
Sponsored by Hospital Nossa Senhora da Conceicao · Phase 3, Interventional, and Treatment
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.
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.
1,078 studies on the registry are indexed under Shock, Septic; 232 are open to participants now.
This study's planned enrollment of 82 is close to the median of 79 across 636 interventional studies indexed under Shock, Septic.
Browse Shock, Septic studies →Hospital Nossa Senhora da Conceicao is the lead sponsor of 21 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
The titrated group will follow the vasopressin weaning protocol used in the DOVSS study (reduction of 0.01 U/min per hour).
Other: Titrated weaning of vasopressin.
The abrupt group will discontinue the vasopressin infusion at the time of randomization, without dose titration.
Other: Abrupt 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).
The abrupt group will discontinue the vasopressin infusion at the time of randomization, without dose titration.
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.
Time frame: 24 hours
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 7 days
Renal replacement therapy
Initiation of hemodialysis between randomization and day 7, excluding chronic dialysis patients.
Time frame: 7 days
Cardiac arrhythmias
Incidence of arrhythmias with hemodynamic consequences between randomization and day 7, defined as hemodynamic deterioration requiring electrical or chemical cardioversion.
Time frame: 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.
Time frame: 28 days
Ischemic events
Occurrence of mesenteric ischemia, ischemic stroke, digital ischemia and acute coronary syndrome between randomization and day 28.
Time frame: 28 days
All-cause mortality
All-cause mortality within 28 days after randomization.
Time frame: 28 days
Plan to share: No
Started Oct 2025 (actual). Primary completion is estimated for Dec 2027, 26 months after the start.
Of 45 non-industry phase 3 interventional studies under Shock, Septic, half reached primary completion within 42 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 59. This study's planned 26 months is below that.
Counting every sponsor, half of 46 studies reached it within 42 months; a quarter within 16 and three quarters within 59.
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