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

NCT07063680 | Recruiting Phase 3

• 1 other identifier: NGUYEN PHRCN 2023
• Study Type: interventional
• Target: 390
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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. 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.

Conditions

Patients With Norepinephrine-refractory Vasoplegic Shock

Outcome Measures

Primary Outcomes (3)

• The mortality rate

  in order to determine whether the administration of vasopressin in addition to norepinephrine improves survival

  At Day 30

• The use of renal replacement therapy within 30 days post-inclusion

  in order to determine whether the administration of vasopressin in addition to norepinephrine improves renal function

  At Day 30

• The persistence of vasopressor use within 15 days post-inclusion

  to determine whether the administration of vasopressin in addition to norepinephrine reduce the duration of shock

  At Day 15

Study Arms (2)

Interventional group

EXPERIMENTAL

Drug: Argipressin; Other: Collection of clinical data

Standard group

ACTIVE COMPARATOR

Drug: Chlorure de sodium; Other: Collection of clinical data

Interventions

Argipressin DRUG

Argipressin 0.4 U.ml-1 (i.e. 40IU diluted in 100ml 0.9% NaCl bag)

Interventional group

Chlorure de sodium DRUG

NaCl 0.9%

Standard group

Collection of clinical data OTHER

At inclusion, D0 to D7, ICU discharge, D30 and D90

Interventional group; Standard group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged ≥ 18 years
• Vasoplegia must be primarily caused by one of the following etiologies:
• Sepsis (documented or clinically suspected infection)
• Post-operative vasoplegia (following cardiac or non-cardiac surgery)
• Post hemorrhage
• Sterile systemic inflammation (e.g., pancreatitis, burns, trauma)
• Anaphylaxis
• Liver failure
• Other causes of vasoplegia
• Refractory shock: dose of vasopressor (express as norepinephrine base equivalent) ≥ 0.25 μg/kg/min in order to maintain perfusion pressure within patient-defined targets (defined by the physician in charge of the patient).
• Early intervention: Criteria for refractory AND vasoplegic shock reached for less than 12 hours.
• Informed consent obtained from the patient or, if unable to give consent, a surrogate. If the surrogate is not available, emergency consent can be considered.
• Covered by French national health insurance

You may not qualify if:

• Ongoing vasopressin treatment
• Ongoing inotrope treatment (except norepinephrine)
• Ongoing acute coronary syndrome, mesenteric ischemia
• Uncontrolled active bleeding
• Vasoplegia due to neurogenic shock
• Vasospastic disease (Raynaud's disease, systemic scleroderma…)
• Hyponatremia \<120 mmol l-1
• Known hypersensitivity to Argipressin or to any of the excipients of REVERPLEG®.
• Patient already enrolled in an interventional trial
• Decision to limit life-sustaining treatments
• Person under legal protection
• Pregnant, parturient or breastfeeding women

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead

Study Sites (1)

CHU Dijon Bourgogne

Dijon, 21000, France

RECRUITING

MeSH Terms

Interventions

Arginine Vasopressin

Intervention Hierarchy (Ancestors)

Vasopressins; Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Central Study Contacts

Maxime NGUYEN

CONTACT

03 80 29 35 28; maxime.nguyen-soenen@chu-dijon.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2025
• First Posted: July 14, 2025
• Study Start: April 7, 2026
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): January 1, 2029
• Last Updated: April 14, 2026

Record last verified: 2026-04

Locations

FR (1)