Acute Pancreatitis, Hypertriglyceridemia
Conditions
Keywords
hyperlipidaemic pancreatitis, Plasmapheresis, insulin
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.
Interventions
DRUGInsulin
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.
DEVICEplasmapheresis
Triglyceridemia should be less than 5.65 mmol/l.
Sponsors
First Affiliated Hospital of Wenzhou Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Severity Score in CT scan | From admition to 7 days | CT Balthazar score/grade or MCTSI score |
| Clinical Severity Score | From admition to 7 days | BISAP score |
| TNF-α in serum, urine | From admition to 7 days | TNF-α |
| cytokines in serum, urine | From admition to 7 days | IL-6, IL-8, IL-10 |
| insulin dose | From admition to 7 days | insulin dose |
Other
| Measure | Time frame | Description |
|---|---|---|
| Genomics | From admition to 7 days | cfDNA et.al. |
| Clinical Severity Score | From admition to 7 days | Ranson score |
Contacts
Primary ContactKeQing Shi, M.D.
Outcome results
None listed