Argipressin

Clinical trials investigating Argipressin are studying how it may help in several urgent and surgical settings. The trials mainly look at outcomes such as survival, organ failure, kidney problems, blood loss, fluid use, and blood pressure support in adults with cardiac arrest, septic shock, vasoplegic shock, and cancer surgery.

Table of Contents

Clinical trial overview

The trial data show that Argipressin is being studied in several serious hospital settings, especially where blood pressure support, organ protection, or survival are key goals.[1] The studies include people with cardiac arrest, septic shock, vasoplegic shock, liver surgery, liver transplantation, chronic thromboembolic pulmonary hypertension, and some cancer-related surgery.[1]

Most of the listed studies are Phase 3 trials, which usually compare a treatment with standard care or placebo in larger groups of patients.[1] One completed study in liver surgery is a Phase 2 trial, which is an earlier stage of testing.[1]

Cardiac arrest and post-resuscitation studies

One major study, NCT05139849, is a randomized trial in cardiac arrest patients and is looking at whether adding vasopressin and steroids to adrenaline can improve 30-day survival.[1] The study is Phase 3, and the planned enrollment is 1,400 patients.[1] Its primary outcome is survival at 30 days.[1]

A second cardiac arrest study, NCT04591990, includes adult patients who have regained circulation after resuscitation, called sustained ROSC (return of spontaneous circulation), but still have hemodynamic failure, meaning poor blood flow and unstable blood pressure.[1] This Phase 3 trial studies Argipressin with hydrocortisone versus placebo, and its main goal is good neurological outcome at day 30, measured with the Glasgow Outcome Scale.[1]

These studies are focused on very sick adults after a life-threatening event, and they look not only at survival but also at brain recovery and overall recovery after resuscitation.[1]

Septic shock and vasoplegic shock studies

Several trials study Argipressin in septic shock, which is a severe state caused by infection that can make blood pressure dangerously low.[1] The 2024-513401-31-00 study is a prospective, randomized, double-blind Phase 3 trial in hyperkinetic septic shock patients, and it measures the difference in SOFA score 48 hours after treatment.[1] The SOFA score is a way to measure organ failure in intensive care.[1]

The 2023-509071-16-00 trial also studies septic shock and asks whether earlier use of vasopressin with norepinephrine can reduce the need for CRRT (continuous renal replacement therapy), which is a kidney support treatment used when kidneys are not working well enough.[1] This Phase 3 trial plans to include 242 patients and looks at kidney-related outcomes during the first 7 days in the intensive care unit.[1]

Another important study, 2024-516639-28-00, is in adults with norepinephrine-refractory vasoplegic shock, meaning shock that does not respond well to norepinephrine treatment.[1] This Phase 3 trial compares early Argipressin with placebo and uses a composite score that includes 30-day mortality, need for renal replacement therapy, and ongoing vasopressor use.[1]

The NCT05568160 trial also studies vasoplegic syndrome, but in patients undergoing cardiac surgery with extracorporeal circulation.[1] It compares vasopressin with norepinephrine and measures a combined outcome of renal complications or death up to 7 days after the syndrome begins.[1]

Major surgery studies

Argipressin is also being studied during major operations where blood pressure and fluid balance matter a lot.[1] The completed NCT05293041 trial, called ARG-01, studied whether Argipressin during hepatic resection could reduce blood loss compared with placebo.[1] This was a Phase 2, double-blinded, randomized, placebo-controlled study in 248 patients, and the main outcome was blood loss at the end of surgery.[1]

The 2023-506512-40-00 AVENIR trial studies low-dose vasopressin during liver transplantation to see whether it reduces post-transplant acute kidney injury.[1] It is a Phase 3 study with 304 planned participants, and it measures the stage of acute kidney injury during the first 7 postoperative days using KDIGO criteria.[1]

The 2025-525153-39-00 trial compares vasopressin with norepinephrine after pulmonary endarterectomy surgery in patients with chronic thromboembolic pulmonary hypertension.[1] This Phase 3 open-label trial plans to enroll 90 patients and measures mean pulmonary arterial pressure, which is the pressure in the artery that carries blood from the heart to the lungs.[1]

Cancer-related studies

Argipressin also appears in some cancer-related trials, although in these studies it is not always the main treatment being tested.[1] The 2024-513598-33-00 HiPRESS study is in people with disseminated cancer and looks at whether low-dose argipressin can lower the total amount of fluid given during CRS-HIPEC surgery, compared with standard noradrenaline under a goal-directed therapy protocol.[1] This Phase 3 study plans to enroll 70 patients.[1]

Two lung cancer trials, NCT06117774 and NCT06211036, list Argipressin among many other study drugs, but the main study questions are about tarlatamab-based treatment strategies in limited-stage and extensive-stage small-cell lung cancer.[1] These are both Phase 3 studies and focus on outcomes such as progression-free survival and overall survival.[1]

Main outcomes being measured

The trial endpoints show what researchers care about most in these studies.[1] In emergency trials, the main outcomes are survival at 30 days and good neurological recovery, because these tell whether patients live and recover brain function after a critical event.[1]

In intensive care trials, researchers often measure kidney outcomes, such as the need for renal replacement therapy, acute kidney injury, or changes in kidney-related scores.[1] In surgery trials, the main outcomes include blood loss, fluid given during surgery, and pressure measurements such as mean pulmonary arterial pressure.[1]

Some cancer trials use cancer endpoints such as PFS and OS, which stand for progression-free survival and overall survival.[1] These outcomes help show whether a treatment delays cancer growth or helps patients live longer.[1]

Study phases and status

Most of the Argipressin-related trials in the data are Phase 3 studies, showing that the treatment is being tested in larger and more advanced trials.[1] The only Phase 2 study in the list is the completed liver surgery trial, which focused on blood loss during hepatic resection.[1]

The study status is mixed: several trials are Authorised, one is Completed, and one is Suspended.[1] This means the research program is active across different clinical settings, but not every study is moving forward at the same time.[1]

Trial ID Phase Condition studied Status Enrollment
NCT05139849 Phase 3 Cardiac arrest Suspended / Authorised 1400
2024-513401-31-00 Phase 3 Septic shock Authorised 120
NCT05568160 Phase 3 Vasoplegic syndrome Authorised 840
NCT05293041 Phase 2 Hepatic resection due to primary malignant disease, metastasis or benign tumour Completed 248
2024-513598-33-00 Phase 3 Disseminated cancer Authorised 70
2023-506512-40-00 Phase 3 Acute Kidney Injury, Liver transplantation Authorised 304
2024-516639-28-00 Phase 3 Norepinephrine-refractory vasoplegic shock Authorised 390
2023-509071-16-00 Phase 3 Septic shock Authorised 242
NCT04591990 Phase 3 Adult cardiac arrest patients with sustained ROSC and hemodynamic failure due to post-resuscitation syndrome Authorised 380
NCT06211036 Phase 3 Extensive stage small cell lung cancer Authorised 558
2025-525153-39-00 Phase 3 Chronic thromboembolic pulmonary hypertension Authorised 90

Ongoing Clinical Trials on Argipressin

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

    Recruiting

    1 1 1
    Investigated diseases:
    France
  • Study on Adding Vasopressin to Treat Patients with Septic Shock

    Recruiting

    1 1 1
    Investigated diseases:
    France
  • Study on Reducing Fluid Use During Cancer Surgery with Argipressin for Patients with Disseminated Cancer

    Recruiting

    1 1 1 1
    Investigated drugs:
    The Netherlands
  • Study on Early Use of Vasopressin and Norepinephrine for Patients with Septic Shock

    Recruiting

    1 1 1 1
    Investigated diseases:
    Italy
  • Study on the Effect of Arginine-Vasopressin and Noradrenaline Tartrate on Acute Kidney Injury in Liver Transplant Patients

    Recruiting

    1 1 1 1
    France
  • Vasopressin Versus Norepinephrine for Patients with Chronic Thromboembolic Pulmonary Hypertension After Pulmonary Endarterectomy Surgery

    Not yet recruiting

    1 1 1 1
    France
  • Study on the Effect of Adrenaline, Vasopressin, and Steroids on Survival in Cardiac Arrest Patients

    Not yet recruiting

    1 1 1 1
    Investigated diseases:
    Sweden
  • Study of Tarlatamab for Patients with Limited-Stage Small-Cell Lung Cancer After Chemoradiotherapy

    Not recruiting

    1 1 1
    Austria Belgium Bulgaria France Germany Greece +6
  • Study of Tarlatamab and Durvalumab compared to Durvalumab alone for patients with extensive stage small cell lung cancer

    Not recruiting

    1 1 1 1
    Austria Belgium Bulgaria Czechia Denmark France +10
  • Study on Argipressin and Sodium Chloride to Reduce Blood Loss in Liver Surgery for Patients with Liver Cancer or Tumors

    Not recruiting

    1 1
    Investigated diseases:
    Sweden

Glossary

  • Cardiac arrest: A sudden stop of the heart. It is an emergency because the body no longer gets enough blood and oxygen.
  • Septic shock: A severe condition caused by infection, where blood pressure becomes dangerously low and organs may not get enough blood.
  • Vasoplegic shock: A type of shock where blood vessels are too relaxed, so blood pressure stays low even with treatment.
  • Phase 3: A later stage of clinical testing that compares a treatment with standard care or placebo in larger groups of patients.
  • Phase 2: An earlier testing stage that looks more closely at whether a treatment may work and how well it performs in a smaller group.
  • Primary outcome: The main result a trial is designed to measure, such as survival, blood loss, or kidney problems.
  • Overall survival (OS): The length of time patients are alive after entering the study.
  • Progression-free survival (PFS): The length of time during which cancer does not get worse.
  • Renal replacement therapy (RRT): A treatment that helps the kidneys do their job when the kidneys are not working well enough.
  • KDIGO criteria: A standard way to define and grade acute kidney injury, which means sudden kidney damage.
  • SOFA score: A score used in intensive care to measure how well organs are working.
  • Glasgow Outcome Scale (GOS): A scale used to measure recovery after brain injury or a severe medical event, including good or poor neurological outcome.

References