Immunoinflammatory Regulation of Esketamine in Septic Patients

Launched by WUHAN UNION HOSPITAL, CHINA · Apr 11, 2021

Keywords

ClinConnect Summary

This clinical trial is investigating whether a medication called esketamine can help reduce inflammation and improve the immune response in patients with sepsis who need mechanical ventilation in the Intensive Care Unit (ICU). Sepsis is a severe condition caused by the body's response to infection, which can lead to serious complications and early death. Esketamine has shown promise in previous studies for its anti-inflammatory effects, and this trial aims to see if giving it through an intravenous infusion for three days can provide benefits for septic patients who are sedated primarily with another medication called propofol.

To participate in this study, patients must be between 18 and 60 years old, require mechanical ventilation for at least 24 hours, and have a certain level of illness severity as measured by the SOFA score. However, individuals with certain health conditions or recent treatments that could interfere with the study are not eligible. Participants can expect to receive the esketamine infusion alongside their usual care in the ICU, and the study will help doctors learn more about the potential benefits of esketamine for patients with sepsis.

Gender

ALL

Eligibility criteria

• 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 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.