Stopping vasopressin in septic shock: gradual versus abrupt
Weaning Approaches for Vasopressin in Sepsis - a Randomized Controlled Trial of Titrated Versus Abrupt Discontinuation During Stabilization of Septic Shock - WAVES Trial
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 |
| Enrollment | 82 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospital Nossa Senhora da Conceicao Academic / other |
| Locations | 1 site (Porto Alegre, Rio Grande do Sul) |
| Trial ID | NCT07067866 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Porto Alegre, Rio Grande do Sul
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.