Intensive Insulin for Severe/Moderate Hypertriglyceridemia Pancreatitis. (HAPinsulin)

Wenzhou Medical University

Status and phase: Unknown; Phase 4

Conditions: Hypertriglyceridemia; Acute Pancreatitis

Treatments: Device: plasmapheresis; Drug: Insulin

Study type: Interventional

Funder types: Other

Identifiers

NCT03501680

HAPinsulin

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 3 patient groups

Group A: intensive insulin

Experimental group

Description:

Group A: intensive insulin (glycemic control 4.4-6.1mmol/L)

Treatment:

Drug: Insulin

Group B: standard insulin

Active Comparator group

Description:

Group B: standard insulin (glycemic control 7.8-10.0 mmol/L),

Treatment:

Drug: Insulin

Group C: plasmapheresis

Active Comparator group

Description:

Group C: plasmapheresis

Treatment:

Device: plasmapheresis