Using esketamine to manage inflammation in septic patients

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

This study is testing if esketamine can help reduce inflammation and improve recovery in patients with sepsis who are on mechanical ventilation.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology (Academic / other)
• Drugs / interventions: chemotherapy, cyclophosphamide
• Locations: 2 sites (Wuhan, Hubei and 1 other locations)
• Trial ID: NCT04843982 on ClinicalTrials.gov

What this trial studies

This study investigates the effects of esketamine on reducing excessive inflammation and improving immunosuppression in patients with sepsis who require mechanical ventilation. It involves administering intravenous esketamine for three consecutive days to assess its safety and efficacy in this critical care setting. The study aims to determine whether esketamine can provide cardiovascular stability while addressing the inflammatory response associated with sepsis. The approach builds on previous findings that suggest esketamine has anti-inflammatory properties.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 60 who are mechanically ventilated and have a SOFA score of 2 or higher.

Not a fit: Patients under 18 or over 60, those with autoimmune diseases, or those who have received recent immunosuppressive treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve outcomes for septic patients by reducing inflammation and enhancing immune function.

How similar studies have performed: Previous studies have shown promising results with esketamine in similar contexts, suggesting potential for success in this novel application.

Eligibility criteria

Inclusion Criteria:

* 18 years old ≤ age ≤60 years old;
* SOFA score ≥2;
* Mechanical ventilation should be required for at least 24 hours when included in the study;
* Informed consent is obtained.

Exclusion Criteria:

* Age \< 18 years old or ≥ 60 years old;
* Previous solid organ or bone marrow transplantation;
* Autoimmune diseases (rheumatoid arthritis, systemic lupus erythematosus, etc.), or hematologic malignancies (leukemia and lymphoma, etc.);
* Received radiotherapy or chemotherapy within the past 30 days, or received immunosuppressant drugs (tripterygium wilfordii, mycophenolate mofetil, cyclophosphamide, FK506, etc.), or continuous treatment with prednisolone more than 10 mg/day (or equivalent doses of the other hormones);
* Unstable angina pectoris or myocardial infarction in the past six months;
* Acute brain injury (traumatic brain injury, subarachnoid hemorrhage, acute ischemic stroke, acute intracranial hemorrhage, acute intracranial infection, etc.);
* Poorly controlled hypertension and congestive heart failure;
* Increased intraocular or intracranial pressure;
* Chronic kidney disease, received continuous renal replacement therapy in the past 30 days, or acute renal failure requiring CRRT;
* Severe chronic liver disease (Child-Pugh class B or C);
* Alcohol dependence, mental illness or severe cognitive impairment;
* Pregnancy or lactation;
* Informed consent is not obtained.

Where this trial is running

Wuhan, Hubei and 1 other locations

• Department of Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China (Not_yet_recruiting)
• Department of Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China (Recruiting)

Study contacts

• Principal investigator: Shiying Yuan, PhD, MD — Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
• Study coordinator: Jiancheng Zhang, PhD, MD

Conditions Esketamine; Sepsis; Inflammatory Response; Immunosuppression