Immunoinflammatory Regulation of Esketamine in Septic Patients

  • STATUS
    Recruiting
  • End date
    Dec 31, 2022
  • participants needed
    100
  • sponsor
    Wuhan Union Hospital, China
Updated on 12 August 2021
mechanical ventilation
continuous infusion
inflammatory response

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.

Details
Condition sepsis syndrome, immune suppression, Sepsis and Septicemia, Inflammatory Response, systemic infections, sepsis, systemic infection, immunosuppressive therapy, Septicemia, s-ketamine, esketamine, Immunosuppression, inflammatory responses
Treatment Esketamine hydrochloride
Clinical Study IdentifierNCT04843982
SponsorWuhan Union Hospital, China
Last Modified on12 August 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

years old age 60 years old
SOFA score 2
Mechanical ventilation should be required for at least 24 hours when included in the study
Informed consent is obtained

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.), or hematologic malignancies (leukemia and lymphoma, etc.)
Received radiotherapy or chemotherapy within the past 30 days, or received immunosuppressant 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 ischemic stroke, 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 30 days, 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
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