Intensive Insulin for Severe/Moderate Hypertriglyceridemia Pancreatitis.

First Affiliated Hospital of Wenzhou Medical University200 enrolled

Overview

The aim of this study is to investigate the therapeutic efficacy of intensive insulin in patients with hypertriglyceridemia induced moderate/severe acute pancreatitis on the course and outcome of disease.

Hypertriglyceridemia-induced acute pancreatitis occurs in about 1-4% of the cases. It is the third leading cause of pancreatitis after biliary and alcoholic etiology. Hypertriglyceridemia can be caused by primary causes, lipid metabolism disorders and secondary causes. Hyperlipidemic pancreatitis can be provoked when triglyceride levels (TGL) exceed 11.3 mmol/l (1,000 mg/dl). Except for standard symptomatic treatment, plasmapheresis and insulin have been performed to rapidly reduce TGL and chylomicron levels in the blood.The therapeutic efficacy of intensive insulin, standard insulin, and plasmapheresis in patients with hypertriglyceridemia induced moderate/severe acute pancreatitis on the course and outcome of disease.After acceptance patients will be randomized by random envelope in the 3 groups: Group A: intensive insulin (glycemic control 4.4-6.1mmol/L), Group B: standard insulin (glycemic control 7.8-10.0 mmol/L), and Group C: plasmapheresis.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

200

Conditions

Acute Pancreatitis Hypertriglyceridemia

Interventions

InsulinDRUG

Group A: intensive insulin (glycemic control 4.4-6.1mmol/L), Group B: standard insulin (glycemic control 7.8-10.0 mmol/L), and Group C: plasmapheresis. Insulin was injected by insulin pump.

plasmapheresisDEVICE

Triglyceridemia should be less than 5.65 mmol/l.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosis of hypertriglyceridemia induced acute pancreatitis (AP): Typical pain increase in serum lipase or amylase with serum TG\> 1,000 mg/dL (11.3mmol/L) or serum was milky with serum TG\> 500 mg/dL(5.65 mmol/L) * Onset of abdominal pain within \<=48h before admission * moderate severe or severe Acute Pancreatitis according to Atlanta criteria * except for other AP causes, such as cholelithiasis, alcohol, drugs and so on Exclusion Criteria: * other etiologies other than hyperlipidemia leading to AP * at the same time combined with other etiologies of AP * appear difficult to reverse respiratory failure, severe systemic circulatory failure, coma and other the endangered symptoms, patients expected to die within 24hours * disseminated intravascular coagulation, or patients with severe active bleeding * without informed consent, the patient refused to plasma replacement, and other circumstances may bring significant bias.

Outcomes

Primary Outcomes

Reduction of mortality

Number of participants with fatal outcome during hospitalisation

Time frame: From admition to hospital discharge, an average of 2 months

Reduction of organ failure

reanl failure, respiratory failure, circulatory failure etal

Time frame: From admition to hospital discharge, an average of 2 months

triglyceride levels

Time frame: From admition to hospital discharge, an average of 2 months