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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| esketamine plus propofol | Experimental | After inclusion, patients are sedated primarily with propofol (0-3 mg/kg/h) using a microinfusion pump and adjusted according to the depth of sedation (Richmond Agitation Sedation Scale (RASS): 0 to -2). 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. |
|
| propofol | No Intervention | After inclusion, patients are sedated primarily with propofol (0-3 mg/kg/h) using a microinfusion pump and adjusted according to the depth of sedation (Richmond Agitation Sedation Scale (RASS): 0 to -2). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Esketamine hydrochloride | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 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 | 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 | 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 | 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 | 72 hours after study inclusion |
| ICU length of stay | Length of stay in the ICU | up to 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Serum concentration of atrial natriuretic peptide (ANP) (0 h) | ANP is secreted primarily by atrial cardiomyocytes | 0 hour after study inclusion |
| Serum concentration of atrial natriuretic peptide (ANP) (48h) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiancheng Zhang, PhD, MD | Contact | +8613554105815 | zhjcheng1@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Shiying Yuan, PhD, MD | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Not yet recruiting | Wuhan | Hubei | 430022 | China |
After the completion of the study, the original data will be sent to the email address: zhjcheng1@163.com, and the password will be provided after the paper is published.
Six months after the paper was published
The raw data supporting the conclusions of this manuscript will be made available by the authors, without undue reservation, to any qualified researcher.
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| ID | Term |
|---|---|
| D018805 | Sepsis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
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ANP is secreted primarily by atrial cardiomyocytes
| 48 hours after study inclusion |
| Serum concentration of atrial natriuretic peptide (ANP) (72h) | ANP is secreted primarily by atrial cardiomyocytes | 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 | 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 | 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 | 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 | 72 hours after study inclusion |
| Sequential organ failure assessment (SOFA) score | 0-43, higher scores correspond to more severe sepsis | 0 hour after study inclusion |
| Sequential organ failure assessment (SOFA) score | 0-43, higher scores correspond to more severe sepsis | 24 hours after study inclusion |
| Sequential organ failure assessment (SOFA) score | 0-43, higher scores correspond to more severe sepsis | 48 hours after study inclusion |
| Sequential organ failure assessment (SOFA) score | 0-43, higher scores correspond to more severe sepsis | 72 hours after study inclusion |
| Mechanical ventilation time after inclusion | Patients requiring mechanical ventilation after study inclusion | Up to 8 weeks |
| Total hospital length of stay | Total length of hospital stay | Through study completion, an average of 2 year |
| Infection complications | Pulmonary infection, urinary tract infection, bloodstream infections, etc | Through study completion, an average of 2 year |
| In-hospital mortality | Mortality rates for the entire period of hospitalization | Through study completion, an average of 2 year |
| 90-day readmission rate | Percentage of readmission to hospital within 90 days of study inclusion | 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 | 0 hour after study inclusion |
| CCL1 expression in alveolar macrophages (24 h) | CCL1 expression in alveolar macrophages collected from bronchoalveolar lavage fluid | 24 hours after study inclusion |
| CCL1 expression in alveolar macrophages (72 h) | CCL1 expression in alveolar macrophages collected from bronchoalveolar lavage fluid | 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 | 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 | 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 | 72 hours after study inclusion |
| Department of Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Recruiting | Wuhan | Hubei | 430022 | China |
|
| D013568 |
| Pathological Conditions, Signs and Symptoms |