Actively Recruiting

Phase 4
Age: 18Years - 80Years
All Genders
NCT04843982

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

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

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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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Immunoinflammatory Regulation of Esketamine in Septic Patients | DecenTrialz