Intensive Insulin for Severe/Moderate Hypertriglyceridemia Pancreatitis.

Study Overview
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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.

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.

Official Title
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Randomized, Controlled, Open-label Trial of Intravenous Intensive Insulin for Severe/Moderate Hypertriglyceridemia Pancreatitis.

Conditions
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Acute Pancreatitis, Hypertriglyceridemia

Intervention / Treatment
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* Drug: Insulin
* Device: plasmapheresis


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A: intensive insulin<br>Group A: intensive insulin (glycemic control 4.4-6.1mmol/L) | Drug: Insulin<br>* 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.<br>|
| Active Comparator: Group B: standard insulin<br>Group B: standard insulin (glycemic control 7.8-10.0 mmol/L), | Drug: Insulin<br>* 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.<br>|
| Active Comparator: Group C: plasmapheresis<br>Group C: plasmapheresis | Device: plasmapheresis<br>* Triglyceridemia should be less than 5.65 mmol/l.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of mortality | Number of participants with fatal outcome during hospitalisation | From admition to hospital discharge, an average of 2 months | 
| Reduction of organ failure | reanl failure, respiratory failure, circulatory failure etal | From admition to hospital discharge, an average of 2 months | 
| triglyceride levels | triglyceride levels | From admition to hospital discharge, an average of 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cytokines in serum, urine | IL-6, IL-8, IL-10 | From admition to 7 days | 
| insulin dose | insulin dose | From admition to 7 days | 
| Severity Score in CT scan | CT Balthazar score/grade or MCTSI score | From admition to 7 days | 
| TNF-α in serum, urine | TNF-α | From admition to 7 days | 
| Clinical Severity Score | BISAP score | From admition to 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hyperlipidaemic pancreatitis, Plasmapheresis, insulin