Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT07063680

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

Led by Centre Hospitalier Universitaire Dijon · Updated on 2026-04-14

390

Participants Needed

1

Research Sites

142 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged �3e= 18 years
  • Vasoplegic shock requiring vasopressor at inclusion with cardiac index �3e= 2.3 L/min/m�B2 and hyperlactatemia > 2 mmol/l
  • Vasoplegia caused primarily by sepsis, post-operative vasoplegia, post hemorrhage, sterile systemic inflammation, anaphylaxis, liver failure, or other causes
  • Refractory shock defined as vasopressor dose �3e= 0.25 bcg/kg/min norepinephrine equivalent
  • Vasoplegic shock refractory for less than 12 hours
  • Informed consent obtained from patient or surrogate
  • Covered by French national health insurance
Not Eligible

You will not qualify if you...

  • Vasoplegic and refractory shock resolved at inclusion
  • Current vasopressin treatment
  • Current inotrope treatment other than norepinephrine
  • Ongoing acute coronary syndrome or mesenteric ischemia
  • Uncontrolled active bleeding
  • Vasoplegia caused by neurogenic shock
  • Vasospastic diseases such as Raynaud's disease or systemic scleroderma
  • Hyponatremia with sodium less than 120 mmol/l
  • Known allergy to Argipressin or its excipients
  • Already enrolled in another interventional trial
  • Decision to limit life-sustaining treatments
  • Person under legal protection
  • Pregnant, parturient, or breastfeeding women

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Trial Site Locations

Total: 1 location

1

CHU Dijon Bourgogne

Dijon, France, 21000

Actively Recruiting

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Research Team

M

Maxime NGUYEN

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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