hypertriglyceridemia-associated acute pancreatitis
Conditions
Interventions
Intervention group:fospropofol disodium
Sponsors
The General Hospital of the Eastern Theater Command of the Chinese People's Liberation Army (Jinling Hospital Affiliated to Nanjing University Medical School)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-70 years; 2.Admission diagnosis of HTG-AP; 3. Within 72 hours of symptom onset; 4. Triglycerides (TG) >= 11.3 mmol/L at enrollment; 5. C-reactive protein (CRP) > 150 mg/L or APACHE II score >= 8 at enrollment; 6. Receiving invasive mechanical ventilation with endotracheal intubation for 48 hours.
Exclusion criteria
Exclusion criteria: 1. Without informed consent form; 2. Expected to die within 48 hours; 3. Known allergy to the study drug or any component of propofol; 4. Pregnancy or lactation; 5. History of psychiatric illness, or history of drug or alcohol abuse; 6. Severe central nervous system diseases, including stroke, intracranial hemorrhage, traumatic brain injury, malignant tumor, cerebral edema, hypoxic-ischemic encephalopathy, etc.; 7. Severe cardiovascular diseases, including unstable angina, acute myocardial infarction, left ventricular ejection fraction <30%, heart rate <50 beats/min, second-degree or third-degree atrioventricular block (patients with an implanted pacemaker may not be excluded); 8. Severe hepatic impairment (Child-Pugh Class C); 9. Chronic kidney disease (glomerular filtration rate <60 mL/min/1.73 m^2); 10. Current participation or participation within 30 days in other interventional drug studies.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of delirium within 28 days after enrollment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Need for rescue sedation;Proportion of effective sedation duration;Number of days alive and free from mechanical ventilation within 14 days;28-day mortality;Adverse event;Triglyceride levels on days 1-7 after enrollment;Incidence of ventilator-associated pneumonia, accidental extubation rate, reintubation rate;Number of days without renal replacement therapy, number of days without vasoactive drug therapy; | — |
Countries
China
Contacts
Public ContactLu Ke
The General Hospital of the Eastern Theater Command of the Chinese People's Liberation Army (Jinling Hospital Affiliated to Nanjing University Medical School)
Outcome results
None listed