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Recruiting NCT04843982

Immunoinflammatory Regulation of Esketamine in Septic Patients

Phase IV Interventional Esketamine Sepsis Inflammatory Response Immunosuppression

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Esketamine hydrochloride.
Who it may be relevant to
Registry conditions: Esketamine, Sepsis, Inflammatory Response, Immunosuppression. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

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.

Primary outcome measures

  • Serum concentration of inflammatory cytokines (0 h) [Time frame: 0 hour after study inclusion]
  • Serum concentration of inflammatory cytokines (48 h) [Time frame: 48 hours after study inclusion]
  • Serum concentration of inflammatory cytokines (72 h) [Time frame: 72 hours after study inclusion]
  • Absolute number of lymphocyte subsets in the peripheral blood (0 h) [Time frame: 0 hour after study inclusion]
  • Absolute number of lymphocyte subsets in the peripheral blood (48 h) [Time frame: 48 hours after study inclusion]
  • Absolute number of lymphocyte subsets in the peripheral blood (72 h) [Time frame: 72 hours after study inclusion]
  • ICU length of stay [Time frame: up to 8 weeks]
Secondary outcome measures (12)
  • Serum concentration of atrial natriuretic peptide (ANP) (0 h) [Time frame: 0 hour after study inclusion]
  • Serum concentration of atrial natriuretic peptide (ANP) (48h) [Time frame: 48 hours after study inclusion]
  • Serum concentration of atrial natriuretic peptide (ANP) (72h) [Time frame: 72 hours after study inclusion]
  • Acute physiology and chronic health evaluation (APACHE) Ⅱ score [Time frame: 0 hour after study inclusion]
  • Acute physiology and chronic health evaluation (APACHE) Ⅱ score [Time frame: 24 hours after study inclusion]
  • Acute physiology and chronic health evaluation (APACHE) Ⅱ score [Time frame: 48 hours after study inclusion]
  • Acute physiology and chronic health evaluation (APACHE) Ⅱ score [Time frame: 72 hours after study inclusion]
  • Sequential organ failure assessment (SOFA) score [Time frame: 0 hour after study inclusion]
  • Sequential organ failure assessment (SOFA) score [Time frame: 24 hours after study inclusion]
  • Sequential organ failure assessment (SOFA) score [Time frame: 48 hours after study inclusion]
  • Sequential organ failure assessment (SOFA) score [Time frame: 72 hours after study inclusion]
  • Mechanical ventilation time after inclusion [Time frame: Up to 8 weeks]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

China · 2 centers
  • Department of Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong Uni — Wuhan
  • Department of Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong Uni — Wuhan

Identifiers

NCT: NCT04843982 · YSY202001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗