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RECRUITING
NCT04843982
PHASE4

Immunoinflammatory Regulation of Esketamine in Septic Patients

Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

View on ClinicalTrials.gov

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.

Official title: Effects of Esketamine Combined With Propofol for Sedation on Systemic Inflammation and Immune Function in Septic Patients in the ICU: a Single-center, Non-blind, Prospective Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2021-07-28

Completion Date

2026-10-30

Last Updated

2025-07-18

Healthy Volunteers

No

Interventions

DRUG

Esketamine hydrochloride

After inclusion, septic patients will be received a single intravenous injection of esketamine (0.7 mg/kg), and then followed by an intravenous administration of esketamine (0.07 mg/kg/h) with an infusion pump for three consecutive days.

Locations (2)

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

Wuhan, Hubei, China

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

Wuhan, Hubei, China