With septic shock
Conditions
Interventions
experimental group:Scopolamine hydrobromide injection + standard therapy
control group:Scopolamine hydrobromide injection analogue + standard therapy
Sponsors
Ruijin Hospital, School of Medicine, Shanghai Jiao Tong University
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1: Referring to the Surviving Sepsis Campaign: International Guidelines for the Management of Sepsis and Septic Shock: 2016, hospitalised patients with a clinical diagnosis of septic shock 2: Age 18~85 years old (including the threshold), gender is not limited 3: Diagnosis of septic shock within 48h; 4: Maximum blood lactate value > 4 mol/L within 48h of the diagnosis of septic shock; 5: Obtain informed consent and signature of the patient or his/her legal representative
Exclusion criteria
Exclusion criteria: 1: Poor prognosis, e.g., particularly severe craniocerebral injury, post-cardiopulmonary resuscitation, advanced malignant tumour, serious various systemic diseases 2: Severe tachyarrhythmias 3: brain dead 4: Patients with cardiogenic shock, obstructive shock, hypovolaemic shock 5: Acute myocardial infarction within 72h 6: Immunosuppressed patients: patients on continuous immunosuppression; hormone use longer than 1 month 7: Exclusion of patients with granulocyte deficiency 8: Exclusion of patients with increased intracranial pressure, acute phase of cerebral haemorrhage, prostatic hypertrophy and elevated intraocular pressure in acute glaucoma 9: Exclusion of patients with an acute gastrointestinal injury classification (AGI) score of 3 or higher 10: Exclusion of patients using extracorporeal membrane pulmonary oxygenation (ECMO) 11: Allergy, history of drug or food allergy or known allergy to the components of this drug 12: Pregnant or planning a pregnancy, breastfeeding women 13: Combined haematological disorders 14: Patients with uncontrolled solid tumours 15: Participation in other clinical trials in the last 3 months 16: Those with an expected survival time of less than 48 hours; 17: Those with other reasons that the researcher considers inappropriate for enrolment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 28-day all-cause mortality; | — |
Secondary
| Measure | Time frame |
|---|---|
| 7-day all-cause mortality;90-day all-cause mortality;hospital mortality;Shock correction rate;No organ failure within 28 days;Blood lactate clearance rate;SOFA, GCS, APACHE II, MODS, AGI;Proportion of patients transferred out of the intensive care unit within 7 and 28 days;Total time in Intensive Care Unit (ICU) stay;Proportion and duration of mechanical ventilation, renal replacement therapy, and ECMO use within 28 days;hospital stay;Usage of vasoactive drugs (norepinephrine, epinephrine, dopamine, dobutamine, meta hydroxylamine) within 28 days: duration of use and total dose (vasoactive drug equivalent); | — |
Countries
China
Contacts
Public ContactChenDechang
Ruijin Hospital, School of Medicine, Shanghai Jiao Tong University
Outcome results
None listed