Actively Recruiting
Immunoinflammatory Regulation of Esketamine in Septic Patients
Led by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Updated on 2025-07-18
100
Participants Needed
2
Research Sites
274 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Immunoinflammatory Regulation of Esketamine in Septic Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 60 years old
- SOFA score of 2 or higher
- Requires mechanical ventilation for at least 24 hours at study inclusion
- Informed consent obtained
You will not qualify if you...
- Age under 18 or 60 and older
- Previous solid organ or bone marrow transplant
- Autoimmune diseases like rheumatoid arthritis or lupus, or blood cancers such as leukemia or lymphoma
- Radiotherapy or chemotherapy in past 30 days, or use of immunosuppressants or high-dose steroids
- Unstable angina or heart attack in past 6 months
- Acute brain injuries such as stroke or hemorrhage
- Poorly controlled high blood pressure or heart failure
- Increased eye or brain pressure
- Chronic kidney disease or recent kidney therapy
- Severe chronic liver disease (Child-Pugh class B or C)
- Alcohol dependence, mental illness, or severe cognitive problems
- Pregnancy or lactation
- Informed consent not obtained
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Department of Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430022
Not Yet Recruiting
2
Department of Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430022
Actively Recruiting
Research Team
J
Jiancheng Zhang, PhD, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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