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Efficacy of Early Argipressin in the Management of Intensive Care Patients With Norepinephrine-refractory Vasoplegic Shock

Study acronym: Vaso²R
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Recruitment opened Primary and study completion pushed from Sep 2028 to Jan 2029 · Start date changed from estimate of Jan 2026 to Apr 7, 2026 · Site details revisedv4 Show 3 more changesShow less
    • Primary and study completion pushed from Sep 2028 to Jan 2029
    • Start date changed from estimate of Jan 2026 to Apr 7, 2026
    • Site details revised
  2. Minor Primary and study completion dates: Aug 2028 to Sep 2028 Start date: Dec 2025 to Jan 2026v3 Show 1 more changeShow less
    • Start date: Dec 2025 to Jan 2026
  3. Notable Start date: Sep 2025 to Dec 2025 Primary and study completion dates: May 2028 to Aug 2028v2 Show 1 more changeShow less
    • Primary and study completion dates: May 2028 to Aug 2028
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Acute circulatory failure (shock) is defined as insufficient oxygen transport to meet the oxygen requirements of organs and tissues. Vasoplegic shock is the most frequent cause of shock, defined by vasoplegia and a drop in arterial pressure with preserved cardiac output. The main aetiologies of vasoplegic shock are sepsis and post-operative vasoplegia. Symptomatic treatment of vasoplegic shock is based on vasopressors. The first-line vasopressor is norepinephrine. Refractory vasoplegic shock refers as high norepinephrine requirements. In patients with catecholamine-refractory vasoplegia, the use of vasopressin as a second-line treatment is proposed. The use of vasopressin could improve organ and tissue perfusion, improve renal function, accelerate shock reversal and reduce patients' exposure to catecholamines, and thus to their side effects. Currently, there is a gap between evidence and guidelines/practice regarding vasopressin in patients with refractory vasoplegic shock: 1. There are no large randomized control trial focusing on vasopressin use in patients with refractory vasoplegic shock and data extrapolated from non-refractory shock have contradictory conclusions regarding the benefit of vasopressin in this population. 2. In patients with vasoplegic shock, expert often recommend vasopressin as second line vasopressor and, in the case of septic shock, current international guidelines clearly position vasopressin as second-line therapy in septic shock and advocate its initiation in patients with vasoplegia refractory to norepinephrine. The strengh of those recommendation is weak due to moderate quality of evidence highlighting the need to conduct a large randomized control trial on this topic. We hypothesize that the use of vasopressin in patients with refractory vasoplegic shock may improve 30-day survival, decrease renal replacement therapy and reduce duration of vasopressor administration. This is the first multicentred study aiming to confirm the superiority of vasopressin in combination with norepinephrine over norepinephrine alone in this population.
Trial Details
NCT Number NCT07063680
Lead Sponsor Centre Hospitalier Universitaire Dijon
Conditions Patients With Norepinephrine-refractory Vasoplegic Shock
Enrollment 390 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov