Immunoinflammatory Regulation of Esketamine in Septic Patients

Last updated: July 17, 2025
Sponsor: Wuhan Union Hospital, China
Overall Status: Active - Recruiting

Phase

4

Condition

Organ Transplant

Soft Tissue Infections

Inflammation

Treatment

Esketamine hydrochloride

Clinical Study ID

NCT04843982
YSY202001
  • Ages 18-80
  • All Genders

Study Summary

Studies have shown that excessive systemic inflammatory response and concomitant immunosuppression are the main cause of early death in patients with sepsis. Therefore, it is very important to reduce excessive inflammation and improve immunosuppression in the acute phase of sepsis. Clinical studies have shown that esketamine combined with propofol for sedation has been proven to be safe and effective for septic patients in the ICU due to its cardiovascular stability. Previous studies have demonstrated that esketamine has anti-inflammatory effects against depression and surgical stress. Our preliminary experimental studies have found that esketamine had strong anti-inflammatory effects in the acute phase of sepsis. However, it is not clear whether esketamine could reduce excessive inflammation and improve immunosuppression in septic patients primarily sedated with a continuous infusion of propofol.

This intervention study is to investigate whether three consecutive days of intravenous esketamine infusions via infusion pump (0.07 mg/kg/h) could reduce excessive inflammation and improve immunosuppression in septic patients requiring mechanical ventilation in the ICU under sedation primarily with propofol.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 18 years old ≤ age ≤60 years old;

  • SOFA score ≥2;

  • Mechanical ventilation should be required for at least 24 hours when included in thestudy;

  • Informed consent is obtained.

Exclusion

Exclusion Criteria:

  • Age < 18 years old or ≥ 60 years old;

  • Previous solid organ or bone marrow transplantation;

  • Autoimmune diseases (rheumatoid arthritis, systemic lupus erythematosus, etc.), orhematologic malignancies (leukemia and lymphoma, etc.);

  • Received radiotherapy or chemotherapy within the past 30 days, or receivedimmunosuppressant drugs (tripterygium wilfordii, mycophenolate mofetil,cyclophosphamide, FK506, etc.), or continuous treatment with prednisolone more than 10 mg/day (or equivalent doses of the other hormones);

  • Unstable angina pectoris or myocardial infarction in the past six months;

  • Acute brain injury (traumatic brain injury, subarachnoid hemorrhage, acute ischemicstroke, acute intracranial hemorrhage, acute intracranial infection, etc.);

  • Poorly controlled hypertension and congestive heart failure;

  • Increased intraocular or intracranial pressure;

  • Chronic kidney disease, received continuous renal replacement therapy in the past 30days, or acute renal failure requiring CRRT;

  • Severe chronic liver disease (Child-Pugh class B or C);

  • Alcohol dependence, mental illness or severe cognitive impairment;

  • Pregnancy or lactation;

  • Informed consent is not obtained.

Study Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: Esketamine hydrochloride
Phase: 4
Study Start date:
July 28, 2021
Estimated Completion Date:
October 30, 2026

Connect with a study center

  • Department of Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei 430022
    China

    Site Not Available

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