Immunoinflammatory Regulation of Esketamine in Septic Patients
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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);
Trial design
Design model
Parallel
Treatments tested in this trial
Esketamine hydrochloride
DrugAfter 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.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: esketamine plus propofolExperimental treatment 1 intervention
Group B: propofolNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Serum concentration of inflammatory cytokines (0 h)
Interleukin (IL)-6, tumor necrosis factor (TNF)-α, IL-2, IL-4, IL-10, IL-17A, and interferon (IFN)-γ
Time frame
0 hour after study inclusion2
Serum concentration of inflammatory cytokines (48 h)
IL-6, TNF-α, IL-2, IL-4, IL-10, IL-17A, and IFN-γ
Time frame
48 hours after study inclusion3
Serum concentration of inflammatory cytokines (72 h)
IL-6, TNF-α, IL-2, IL-4, IL-10, IL-17A, and IFN-γ
Time frame
72 hours after study inclusion4
Absolute number of lymphocyte subsets in the peripheral blood (0 h)
CD3(+), CD3(+) CD4(+), CD3(+) CD8(+), CD3(-) CD16(+) CD56(+) , and CD19(+) cells
Time frame
0 hour after study inclusionSecondary outcomes
1
Serum concentration of atrial natriuretic peptide (ANP) (0 h)
ANP is secreted primarily by atrial cardiomyocytes
Time frame
0 hour after study inclusion2
Serum concentration of atrial natriuretic peptide (ANP) (48h)
ANP is secreted primarily by atrial cardiomyocytes
Time frame
48 hours after study inclusion3
Serum concentration of atrial natriuretic peptide (ANP) (72h)
ANP is secreted primarily by atrial cardiomyocytes
Time frame
72 hours after study inclusion4
Acute physiology and chronic health evaluation (APACHE) Ⅱ score
0-67, higher scores correspond to more severe disease and a higher risk of death
Time frame
0 hour after study inclusionSponsors and contacts
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Source ClinicalTrials.gov