Patients With Norepinephrine-refractory Vasoplegic ShockPhase 3Vaso²RNCT07063680
Efficacy of Early Argipressin in the Management of Intensive Care Patients With Norepinephrine-refractory Vasoplegic Shock
A Phase 3 study testing Argipressin, Chlorure de sodium and Collection of clinical data in people with Patients With Norepinephrine-refractory Vasoplegic Shock, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients With Norepinephrine-refractory Vasoplegic Shock
- What is being tested?
- Argipressin, Chlorure de sodium and Collection of clinical data
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 390 participants
- Where
- 1 siteFrance
- Study dates
- 7 Apr 2026to Jan 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged ≥ 18 years
- Vasoplegic shock defined as patient requiring vasopressor at the time of inclusion AND with a cardiac index ≥ 2.3/L/min/m² [32] (measured by echocardiography, Swan-Ganz, pulse contour analysis or thermodilution) and with hyperlactatemia > 2 mmol/l.
- 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
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- 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
Who cannot join
- Patients that do not present the criteria for vasoplegic AND refractory shock at the time of inclusion anymore (resolved condition)
- Ongoing vasopressin treatment
- Ongoing inotrope treatment (except norepinephrine)
- Ongoing acute coronary syndrome, mesenteric ischemia
- Uncontrolled active bleeding
- Vasoplegia due to neurogenic shock
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Dijon Bourgogne
Dijon, 21000
Maxime NGUYEN, 03 80 29 35 28 ext. +33, nguyen-soenen@chu-dijon.fr
About this study
Official title: Efficacy of Early Argipressin (Arginine Vasopressin) in the Management of Intensive Care Patients With Norepinephrine-refractory Vasoplegic Shock: a Multicentric Randomized, Double-blind Placebo-controlled Superiority Trial
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:
Read more
- 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.
- 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.
- Being tested
- Argipressin, Chlorure de sodium, Collection of clinical data
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ArgipressinDrug
Argipressin 0.4 U.ml-1 (i.e. 40IU diluted in 100ml 0.9% NaCl bag)
Chlorure de sodiumDrug
NaCl 0.9%
Collection of clinical dataOther
At inclusion, D0 to D7, ICU discharge, D30 and D90
| Study group | Role | What they receive |
|---|---|---|
| Interventional group | Experimental | Not described Receives: Drug: Argipressin; Other: Collection of clinical data |
| Standard group | Active comparator | Not described Receives: Drug: Chlorure de sodium; Other: Collection of clinical data |
What is being measured
The primary outcome is the main question the study is designed to answer.
The mortality rate
in order to determine whether the administration of vasopressin in addition to norepinephrine improves survival
Measured: 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
Measured: 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
Measured: At Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2025
- Study start7 Apr 2026
- Primary completionJan 2029 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With Norepinephrine-refractory Vasoplegic ShockStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 390 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07063680
- Sponsor's protocol ID
- NGUYEN PHRCN 2023
- Acronym
- Vaso²R
- Status last verified
- Apr 2026
- First submitted
- 3 Jul 2025
- Last updated
- 14 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Early Argipressin (Arginine Vasopressin) in the Management of Intensive Care Patients With Norepinephrine-refractory Vasoplegic Shock: a Multicentric Randomized, Double-blind Placebo-controlled Superiority Trial
- ClinicalTrials.gov ID
- NCT07063680
- Acronym / sponsor ID
- Vaso²R / NGUYEN PHRCN 2023
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 390 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 7 Apr 2026 (actual)
- Primary completion
- Jan 2029 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 14 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional group | Experimental | Drug: Argipressin, Other: Collection of clinical data |
| Standard group | Active comparator | Drug: Chlorure de sodium, Other: Collection of clinical data |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Patients aged ≥ 18 years
- Vasoplegic shock defined as patient requiring vasopressor at the time of inclusion AND with a cardiac index ≥ 2.3/L/min/m² [32] (measured by echocardiography, Swan-Ganz, pulse contour analysis or thermodilution) and with hyperlactatemia > 2 mmol/l.
- Vasoplegia must be primarily caused by one of the following etiologies:
- 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.
Key exclusion criteria (13 listed)
- Patients that do not present the criteria for vasoplegic AND refractory shock at the time of inclusion anymore (resolved condition)
- Ongoing vasopressin treatment
- Ongoing inotrope treatment (except norepinephrine)
- Ongoing acute coronary syndrome, mesenteric ischemia
- Uncontrolled active bleeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ArgipressinArgipressin 0.4 U.ml-1 (i.e. 40IU diluted in 100ml 0.9% NaCl bag) | Drug | Interventional group |
| Chlorure de sodiumNaCl 0.9% | Drug | Standard group |
| Collection of clinical dataAt inclusion, D0 to D7, ICU discharge, D30 and D90 | Other | Interventional group, Standard group |
Primary outcome
The mortality rate
Time frame: At Day 30
in order to determine whether the administration of vasopressin in addition to norepinephrine improves survival
The use of renal replacement therapy within 30 days post-inclusion
Time frame: At Day 30
in order to determine whether the administration of vasopressin in addition to norepinephrine improves renal function
The persistence of vasopressor use within 15 days post-inclusion
Time frame: At Day 15
to determine whether the administration of vasopressin in addition to norepinephrine reduce the duration of shock
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Argipressin, Chlorure de sodium and Collection of clinical data in people with Patients With Norepinephrine-refractory Vasoplegic Shock, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maxime NGUYEN (03 80 29 35 28 ext. +33, maxime.nguyen-soenen@chu-dijon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The mortality rate (time frame: At Day 30). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.