Weaning Approaches for Vasopressin in Sepsis

Last updated: July 6, 2025
Sponsor: Hospital Nossa Senhora da Conceicao
Overall Status: Active - Not Recruiting

Phase

3

Condition

Sepsis And Septicemia

Low Blood Pressure (Hypotension)

Treatment

Titrated weaning of vasopressin.

Abrupt weaning of vasopressin.

Clinical Study ID

NCT07067866
CAAE: 83246724.1.0000.5530
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age over 18 years

  • Admitted to the Intensive Care Unit

  • Patients with vasopressor dependent sepsis

  • Receiving combined norepinephrine and vasopressin therapy

Exclusion

Exclusion Criteria:

  • Withdrawal/reduction of vasopressin related to a plan of treatment limitation orpalliative care

  • Withdrawal/reduction of vasopressin associated with the initiation of adrenaline orany other vasopressor

Study Design

Total Participants: 82
Treatment Group(s): 2
Primary Treatment: Titrated weaning of vasopressin.
Phase: 3
Study Start date:
October 01, 2025
Estimated Completion Date:
October 01, 2028

Study 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, Lam et al. published the first study 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, Murata et al. published another retrospective observational study also 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.