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Tests treatment safety and results for Patients With Norepinephrine-refractory Vasoplegic Shock
Official title Efficacy of Early Argipressin in the Management of Intensive Care Patients With Norepinephrine-refractory Vasoplegic Shock
ClinicalTrials.gov ID: NCT07063680
What this study is testing
What is Argipressin?
Argipressin is an investigational medicine, being studied as a potential treatment for patients with norepinephrine-refractory vasoplegic shock.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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)
You likely can't join if
- 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
See the full eligibility criteria
- 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...
- 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...
- 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
- 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
- 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 treatment trial
- Decision to limit life-sustaining treatments
- Person under legal protection
- Pregnant, parturient or breastfeeding women
The study team makes the final eligibility decision.
Where it's taking place
- Dijon, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Dijon, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.