Intensive Insulin for Severe/Moderate Hypertriglyceridemia Pancreatitis.

Phase 4

• Conditions: Acute Pancreatitis; Hypertriglyceridemia
• Interventions: Device: plasmapheresis; Drug: Insulin

• Registration Number: NCT03501680
• Lead Sponsor: First Affiliated Hospital of Wenzhou Medical University

Brief Summary

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

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 Timeline

• Study First Submitted: 2018-03-29
• Study First Submitted QC: 2018-04-10
• Study First Posted: 2018-04-18
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-04
• Study Start: 2018-06-06
• Last Update Posted: 2018-06-06
• Primary Completion: 2020-03-08
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group C: plasmapheresis	plasmapheresis	Group C: plasmapheresis
Group A: intensive insulin	Insulin	Group A: intensive insulin (glycemic control 4.4-6.1mmol/L)
Group B: standard insulin	Insulin	Group B: standard insulin (glycemic control 7.8-10.0 mmol/L),

Primary Outcome Measures

Name	Time	Method
Reduction of organ failure	From admition to hospital discharge, an average of 2 months	reanl failure, respiratory failure, circulatory failure etal
triglyceride levels	From admition to hospital discharge, an average of 2 months	triglyceride levels
Reduction of mortality	From admition to hospital discharge, an average of 2 months	Number of participants with fatal outcome during hospitalisation

Secondary Outcome Measures

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