Intensive Insulin for Severe/Moderate Hypertriglyceridemia Pancreatitis.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-06

Study Completion Date

2020-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Acute Pancreatitis Hypertriglyceridemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group A: intensive insulin

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

Group Type EXPERIMENTAL

Insulin

Intervention Type DRUG

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.

Group B: standard insulin

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

Group Type ACTIVE_COMPARATOR

Insulin

Intervention Type DRUG

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.

Group C: plasmapheresis

Group Type ACTIVE_COMPARATOR

plasmapheresis

Intervention Type DEVICE

Triglyceridemia should be less than 5.65 mmol/l.

Interventions

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Insulin

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.

Intervention Type DRUG

plasmapheresis

Triglyceridemia should be less than 5.65 mmol/l.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No