NCT03342807UnknownPhase 4
Randomized, Controlled, Multicenter Studies of the Effects of Intravenous Administration of Insulin and Plasma Exchange on Triglyceride Levels in Early Stage of Hypertriglyceridemia-induced Pancreatitis
Peking Union Medical College Hospital0 sites220 target enrollmentStarted: November 2017Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Enrollment
- 220
- Primary Endpoint
- serum TG
Study Overview
Brief Summary
To investigate an economical and effective way to reduce the level of serum triglyceride in patients with hypertriglyceridemia-induced acute pancreatitis.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adult aged 18 to 80 years old;
- •abdominal pain consistent with AP;
- •serum amylase and / or lipase activity is at least 3 times higher than the normal upper limit;
- •abdominal imaging consistent with AP imaging changes.
- •severe hyperlipidemia "fasting serum TG> 1,000 mg/dL (11.2mmol/L)";
- •except for other AP causes, such as cholelithiasis, alcohol, drugs and so on.
Exclusion Criteria
- •other etiologies other than hyperlipidemia leading to AP;
- •fasting serum TG less than 1,000 mg / dL (11.2mmol / L);
- •acute lipid-induced pancreatitis at the same time combined with other etiologies of acute pancreatitis.
- •the existence of plasma replacement contraindications: serious allergies to plasma, human serum albumin, heparin and others; the existence of mental disorders; unstable heart or cerebral infarction; intracranial hemorrhage or severe cerebral edema associated with hernia.
- •without informed consent, the patient refused to plasma replacement, and other circumstances may bring significant bias.
Arms & Interventions
Group Insulin
Experimental
Intervention: Insulin (Drug)
Group Aphesis
Experimental
Intervention: Aphesis (Device)
Outcomes
Primary Outcomes
serum TG
Time Frame: every 4 hours in first 3 days
Elimination of serum triglyceride.
Secondary Outcomes
No secondary outcomes reported
Investigators
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