Clinical Trial

Immunoinflammatory Regulation of Esketamine in Septic Patients

Recruiting Phase 4
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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.
Protocol Amendment History 7 amendments
This ClinicalTrials.gov record has been amended 7 times since 2021-04-11; most recent amendment 2025-07-17.
Status change: Not Yet Recruiting → Recruiting 2021-07-29
Trial Details
NCT Number NCT04843982
Lead Sponsor Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Conditions Esketamine, Sepsis, Inflammatory Response, Immunosuppression
Enrollment 100 participants
Start Date 2021-07-28
Primary Completion 2026-10-30 (estimated)
Study Completion 2026-10-30 (estimated)
Updated on ClinicalTrials.gov 2025-07-18