Stopping vasopressin in septic shock: gradual versus abrupt
Official title: Weaning Approaches for Vasopressin in Sepsis - a Randomized Controlled Trial of Titrated Versus Abrupt Discontinuation During Stabilization of Septic Shock - WAVES Trial
Run by Hospital Nossa Senhora da Conceicao · NCT07067866 · Data updated 2026-11-12
This trial will test whether slowly reducing vasopressin or stopping it suddenly causes less low blood pressure in adults in the ICU with septic shock who are on both vasopressin and norepinephrine.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 82 (estimated) |
| Sponsor | Hospital Nossa Senhora da Conceicao Academic / other |
| Locations | 1 site (Porto Alegre, Rio Grande do Sul) |
| Status | Recruiting |
| Started | October 1, 2025 |
| Main results expected | December 31, 2027 |
| Study ends | October 1, 2028 |
| Registry record updated | January 2, 2026 |
| Trial ID | NCT07067866 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (age ≥18) admitted to the ICU with vasopressor-dependent septic shock who are receiving combined norepinephrine and vasopressin and are not undergoing palliative treatment or planned initiation of other vasopressors at the time of vasopressin change.
✕Probably not a fit
Patients not on combined vasopressin and norepinephrine, pediatric patients, those in palliative care, or patients whose vasopressin is stopped because another vasopressor is being started are unlikely to benefit from this trial's findings.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a randomized, phase 3 trial comparing two approaches to vasopressin withdrawal—titrated (gradual) reduction versus abrupt cessation—in adults with vasopressor-dependent septic shock. The main outcome is the incidence of clinically significant hypotension during vasopressin weaning. Eligible patients are ICU adults receiving combined norepinephrine and vasopressin; those with planned treatment limitation or who require initiation of other vasopressors at the time of vasopressin change are excluded. The trial is conducted at a single center in Porto Alegre, Brazil, using standard ICU monitoring and protocols to record hemodynamic events during and after weaning.
Why it matters
Potential benefit: If successful, the results could reduce episodes of dangerously low blood pressure during vasopressin withdrawal and help clinicians choose a safer weaning method.
How similar studies have gone: Previous evidence is limited to retrospective observational analyses (including a 1,318-patient cohort and a smaller 74-patient series) that found no clear overall difference between abrupt and gradual withdrawal, though subgroup analyses suggested possible differences when catecholamines were still being given; randomized data are currently lacking.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age over 18 years * Admitted to the Intensive Care Unit * Patients with vasopressor dependent sepsis * Receiving combined norepinephrine and vasopressin therapy Exclusion Criteria: * 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
Where it's running
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Hospital Nossa Senhora da Conceição
Porto Alegre, Rio Grande do Sul, Brazil Recruiting
Study contacts
- Principal investigator: Cássio Mallmann, Critical Care Physician, MS — Hospital Nossa Senhora da Conceicao
- Study coordinator: Wagner Luis Nedel, Critical Care Physician, PhD
- Email: wagnernedel@gmail.com
- Phone: 55 51 999547554
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.