Randomized, Controlled, Open-label Trial of Intravenous Intensive Insulin for Severe/Moderate Hypertriglyceridemia Pancreatitis.
Overview
- Phase
- Phase 4
- Intervention
- Insulin
- Conditions
- Acute Pancreatitis
- Sponsor
- First Affiliated Hospital of Wenzhou Medical University
- Enrollment
- 200
- Primary Endpoint
- Reduction of organ failure
- Last Updated
- 7 years ago
Overview
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.
Investigators
Meng-Tao Zhou
The director of the department of pancreatitis; the president of First Affiliated Hospital of Wenzhou Medical Univeristy
First Affiliated Hospital of Wenzhou Medical University
Eligibility Criteria
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.
Arms & Interventions
Group A: intensive insulin
Group A: intensive insulin (glycemic control 4.4-6.1mmol/L)
Intervention: Insulin
Group B: standard insulin
Group B: standard insulin (glycemic control 7.8-10.0 mmol/L),
Intervention: Insulin
Group C: plasmapheresis
Group C: plasmapheresis
Intervention: plasmapheresis
Outcomes
Primary Outcomes
Reduction of organ failure
Time Frame: From admition to hospital discharge, an average of 2 months
reanl failure, respiratory failure, circulatory failure etal
triglyceride levels
Time Frame: From admition to hospital discharge, an average of 2 months
triglyceride levels
Reduction of mortality
Time Frame: From admition to hospital discharge, an average of 2 months
Number of participants with fatal outcome during hospitalisation
Secondary Outcomes
- cytokines in serum, urine(From admition to 7 days)
- Severity Score in CT scan(From admition to 7 days)
- TNF-α in serum, urine(From admition to 7 days)
- insulin dose(From admition to 7 days)
- Clinical Severity Score(From admition to 7 days)