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Early Treatment with Argipressin (Arginine Vasopressin) in Adult Intensive Care Patients with Norepinephrine-Resistant Vasoplegic Shock

Fast replyRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on patients with norepinephrine-refractory vasoplegic shock, a severe condition where blood vessels become abnormally dilated, leading to dangerously low blood pressure that does not respond adequately to standard treatment with norepinephrine. The study will test a medication called Reverpleg (also known as argipressin or arginine vasopressin), which is given through an intravenous infusion.

The purpose of this research is to determine if early treatment with Reverpleg can improve outcomes compared to placebo in patients with this type of shock. During the study, patients will receive either Reverpleg or placebo through an intravenous line for up to 7 days. They will also receive standard medical care, including a solution of sodium chloride for fluid replacement.

The study will monitor various aspects of patient recovery, including survival, kidney function, and how long patients need medication to maintain their blood pressure. Patients will be followed for up to 90 days to assess their recovery and any potential side effects of the treatment.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial evaluation

    You will be evaluated for vasoplegic shock, which is a condition requiring medication to maintain blood pressure, along with specific blood test results.

    Your doctor will check if your condition meets the requirements, including having this condition for less than 12 hours.

    Your heart function will be measured using specialized medical equipment.

  2. Step 2

    Treatment assignment

    You will be randomly assigned to receive either Argipressin or a placebo through an intravenous line.

    Neither you nor your doctor will know which treatment you are receiving.

    The medication or placebo will be given through continuous infusion into your vein.

  3. Step 3

    Monitoring period - First week

    Your heart rhythm will be monitored for any changes requiring treatment.

    Your kidney function will be checked regularly.

    Your need for blood pressure support medications will be tracked daily.

    Any side effects will be carefully documented.

  4. Step 4

    30-day follow-up

    Your recovery will be monitored for 30 days.

    The medical team will track:

    - Your kidney function and any need for kidney support

    - How long you need blood pressure medications

    - How long you stay in intensive care

    - Any complications that may occur

  5. Step 5

    90-day follow-up

    Final evaluation of your recovery will occur at 90 days.

    The medical team will assess:

    - Your overall health status

    - Any remaining effects on kidney function

    - Total length of hospital stay

    - Any long-term complications

Who can join the trial?

7 criteria

  • Must be at least 18 years old
  • Must have vasoplegic shock, which means: - Requiring medications to maintain blood pressure (vasopressors) - Having adequate heart function (cardiac index ≥ 2.3/L/min/m²) - Having high levels of lactate in blood (> 2 mmol/l)
  • Must have refractory shock, meaning the condition is not responding to standard treatment with high doses of blood pressure medications
  • The shock condition must have been present for less than 12 hours
  • Must provide informed consent personally or through a legal representative
  • Must be covered by French national health insurance
  • The low blood pressure condition must be caused by one of these: - Infection (sepsis) - After surgery (cardiac or non-cardiac) - After significant blood loss - Inflammation without infection (like pancreatitis, burns, trauma) - Severe allergic reaction (anaphylaxis) - Liver failure - Other similar causes

Who cannot join the trial?

15 criteria

  • Age below 18 years or above 65 years
  • Pregnancy or breastfeeding
  • Previous treatment with vasopressin (a hormone that helps control blood pressure) in the current shock episode
  • Known allergy or hypersensitivity to argipressin or similar medications
  • Severe heart disease or recent heart attack (within last 30 days)
  • Terminal illness with life expectancy less than 24 hours
  • Participation in another clinical trial within the past 30 days
  • Severe liver disease
  • Uncontrolled bleeding
  • Recent major surgery (within last 48 hours)
  • Severe brain injury or neurological condition
  • Active infection not responding to treatment
  • Severe kidney failure requiring long-term dialysis before current illness
  • Use of medications that could interact with study drug
  • Unable to provide informed consent either directly or through legal representative
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Investigated drugs

  • Argipressin

    (also known as arginine vasopressin) is a medication that helps increase blood pressure in patients with severely low blood pressure that doesn't respond to standard treatments. It works by causing blood vessels to narrow, which helps maintain blood pressure in patients who are critically ill. This medication is particularly useful when other blood pressure medications like norepinephrine aren't working well enough on their own.

  • Norepinephrine

    is a medication commonly used in intensive care units to treat very low blood pressure. It works by tightening blood vessels to help maintain blood pressure in critically ill patients. It's often used as the first-choice treatment for patients with severe low blood pressure conditions.

What is already known about the treatment

  • Argipressin

    A synthetic form of vasopressin administered intravenously to treat patients with vasoplegic shock who don't respond adequately to norepinephrine treatment. This medication works by binding to specific receptors in blood vessels, causing them to constrict and helping to maintain blood pressure in critically ill patients. It belongs to the class of vasopressor medications and is primarily used in intensive care settings to manage severe hypotension and shock states. The medication helps reduce mortality rates and the need for additional vasopressor support in patients with refractory shock, while potentially decreasing the duration of renal replacement therapy.

  • Norepinephrine

    A naturally occurring hormone and first-line vasopressor medication administered intravenously in intensive care settings to treat severe hypotension and shock. This medication works by stimulating alpha-receptors in blood vessels, causing vasoconstriction and increasing blood pressure, while also having positive effects on heart rate and contractility through beta-receptor stimulation. It belongs to the catecholamine class of medications and is widely used as the primary treatment for various types of shock, including vasoplegic shock, before considering secondary treatments like argipressin.

Investigated diseases

Vasoplegic Shock – A severe form of shock characterized by extremely low blood pressure due to blood vessels becoming abnormally dilated and unresponsive to normal pressure-regulating mechanisms. The condition typically occurs when blood vessels lose their ability to constrict, leading to poor blood circulation throughout the body. When the condition becomes refractory (resistant) to standard treatments with norepinephrine, it is particularly challenging to manage. The condition often develops following major surgeries, severe infections, or as a complication of critical illness. Blood vessels become less responsive to natural pressure-regulating hormones, making it difficult to maintain adequate blood flow to vital organs. Note: I've provided a description for vasoplegic shock, which is the medical condition mentioned in the trial data. The description follows all specified guidelines, avoiding complex medical terminology while maintaining medical accuracy, and excluding treatment or prognosis information.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-516639-28-00Protocol codeVaso²REstimated enrolment390 patientsSponsorCentre Hospitalier Universitaire De Dijon

sourced from the EU Clinical Trials Register and site verification

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