Actively Recruiting
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
Led by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Updated on 2025-07-18
100
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the effects of esketamine combined with propofol sedation on inflammation and immune function in adults with sepsis who need mechanical ventilation in the ICU. Excessive inflammation and immune suppression contribute to early death in sepsis, so this study aims to see if esketamine can reduce inflammation and improve immune response during the acute phase. Esketamine has shown anti-inflammatory effects in previous studies and may offer cardiovascular stability during sedation. Participants are randomly assigned to one of two groups. One group receives sedation primarily with propofol adjusted to maintain a moderate sedation level, while the other group receives a single intravenous injection of esketamine followed by a continuous infusion for three days alongside propofol sedation. The esketamine infusion is delivered via pump at a fixed rate for three consecutive days to assess its effects on inflammation and immune function. Throughout the study, researchers will measure inflammatory cytokines and lymphocyte numbers in the blood at multiple time points up to 72 hours after inclusion. They will also track ICU length of stay and other health scores related to organ function and severity of illness. Safety and clinical outcomes, including hospital stay length and mortality, will be monitored for up to two years. This study lasts from initial inclusion through long-term follow-up to fully evaluate esketamine's impact on sepsis patients under sedation.
CONDITIONS
Brief 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
- Mechanical ventilation required for at least 24 hours at study inclusion
- Informed consent obtained
You will not qualify if you...
- Age less than 18 or 60 years old and above
- Previous solid organ or bone marrow transplantation
- Autoimmune diseases such as rheumatoid arthritis or systemic lupus erythematosus
- Hematologic cancers like leukemia or lymphoma
- Received radiotherapy or chemotherapy within past 30 days
- Use of immunosuppressant drugs or prednisolone over 10 mg/day
- Unstable angina or myocardial infarction in past 6 months
- Acute brain injury including stroke or intracranial hemorrhage
- Poorly controlled hypertension or congestive heart failure
- Increased intraocular or intracranial pressure
- Chronic kidney disease or recent continuous renal replacement therapy
- Severe chronic liver disease (Child-Pugh class B or C)
- Alcohol dependence, mental illness, or severe cognitive impairment
- Pregnancy or breastfeeding
- Informed consent not obtained
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 days
Participants receive sedation primarily with propofol. Those in the experimental group receive a single intravenous injection of esketamine followed by continuous esketamine infusion for three consecutive days.
Daily visits for 3 days
Duration - Up to 2 years
Participants are monitored for up to 8 weeks for ICU stay, mechanical ventilation, and health outcomes, with extended observation for up to 2 years for hospital stay, infection complications, mortality, and readmission rates.
Periodic visits depending on clinical status
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here