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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
100
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.
Department of Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
NOT_YET_RECRUITINGDepartment of Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
RECRUITINGSerum 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 inclusion
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 inclusion
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 inclusion
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 inclusion
Absolute number of lymphocyte subsets in the peripheral blood (48 h)
CD3(+), CD3(+) CD4(+), CD3(+) CD8(+), CD3(-) CD16(+) CD56(+) , and CD19(+) cells
Time frame: 48 hours after study inclusion
Absolute number of lymphocyte subsets in the peripheral blood (72 h)
CD3(+), CD3(+) CD4(+), CD3(+) CD8(+), CD3(-) CD16(+) CD56(+) , and CD19(+) cells
Time frame: 72 hours after study inclusion
ICU length of stay
Length of stay in the ICU
Time frame: up to 8 weeks
Serum concentration of atrial natriuretic peptide (ANP) (0 h)
ANP is secreted primarily by atrial cardiomyocytes
Time frame: 0 hour after study inclusion
Serum concentration of atrial natriuretic peptide (ANP) (48h)
ANP is secreted primarily by atrial cardiomyocytes
Time frame: 48 hours after study inclusion
Serum concentration of atrial natriuretic peptide (ANP) (72h)
ANP is secreted primarily by atrial cardiomyocytes
Time frame: 72 hours after study inclusion
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 inclusion
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: 24 hours after study inclusion
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: 48 hours after study inclusion
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: 72 hours after study inclusion
Sequential organ failure assessment (SOFA) score
0-43, higher scores correspond to more severe sepsis
Time frame: 0 hour after study inclusion
Sequential organ failure assessment (SOFA) score
0-43, higher scores correspond to more severe sepsis
Time frame: 24 hours after study inclusion
Sequential organ failure assessment (SOFA) score
0-43, higher scores correspond to more severe sepsis
Time frame: 48 hours after study inclusion
Sequential organ failure assessment (SOFA) score
0-43, higher scores correspond to more severe sepsis
Time frame: 72 hours after study inclusion
Mechanical ventilation time after inclusion
Patients requiring mechanical ventilation after study inclusion
Time frame: Up to 8 weeks
Total hospital length of stay
Total length of hospital stay
Time frame: Through study completion, an average of 2 year
Infection complications
Pulmonary infection, urinary tract infection, bloodstream infections, etc
Time frame: Through study completion, an average of 2 year
In-hospital mortality
Mortality rates for the entire period of hospitalization
Time frame: Through study completion, an average of 2 year
90-day readmission rate
Percentage of readmission to hospital within 90 days of study inclusion
Time frame: Through study completion, an average of 2 year
CCL1 expression in alveolar macrophages (0 h)
CCL1 expression in alveolar macrophages collected from bronchoalveolar lavage fluid
Time frame: 0 hour after study inclusion
CCL1 expression in alveolar macrophages (24 h)
CCL1 expression in alveolar macrophages collected from bronchoalveolar lavage fluid
Time frame: 24 hours after study inclusion
CCL1 expression in alveolar macrophages (72 h)
CCL1 expression in alveolar macrophages collected from bronchoalveolar lavage fluid
Time frame: 72 hours after study inclusion
expression of WNT pathway proteins in alveolar macrophages (0 h)
Wnt5a, FZD5, b-catenin, Lef1 expression in alveolar macrophages collected from bronchoalveolar lavage fluid
Time frame: 0 hour after study inclusion
expression of WNT pathway proteins in alveolar macrophages (24 h)
Wnt5a, FZD5, b-catenin, Lef1 expression in alveolar macrophages collected from bronchoalveolar lavage fluid
Time frame: 24 hours after study inclusion
expression of WNT pathway proteins in alveolar macrophages (72 h)
Wnt5a, FZD5, b-catenin, Lef1 expression in alveolar macrophages collected from bronchoalveolar lavage fluid
Time frame: 72 hours after study inclusion
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