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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A: intensive insulin | Experimental | Group A: intensive insulin (glycemic control 4.4-6.1mmol/L) |
|
| Group B: standard insulin | Active Comparator | Group B: standard insulin (glycemic control 7.8-10.0 mmol/L), |
|
| Group C: plasmapheresis | Active Comparator | Group C: plasmapheresis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin | 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. |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Genomics | cfDNA et.al. | From admition to 7 days |
| Clinical Severity Score | Ranson score | From admition to 7 days |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| KeQing Shi, M.D. | Contact | (086)15858515296 | skochilly@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Meng-Tao Zhou, M.D. | The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22201145 | Background | Lutfi R, Huang J, Wong HR. Plasmapheresis to treat hypertriglyceridemia in a child with diabetic ketoacidosis and pancreatitis. Pediatrics. 2012 Jan;129(1):e195-8. doi: 10.1542/peds.2011-0217. Epub 2011 Dec 26. | |
| 19293788 | Background | Tsuang W, Navaneethan U, Ruiz L, Palascak JB, Gelrud A. Hypertriglyceridemic pancreatitis: presentation and management. Am J Gastroenterol. 2009 Apr;104(4):984-91. doi: 10.1038/ajg.2009.27. Epub 2009 Mar 17. |
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| ID | Term |
|---|---|
| D010195 | Pancreatitis |
| D015228 | Hypertriglyceridemia |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
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| ID | Term |
|---|---|
| D007328 | Insulin |
| D010956 | Plasmapheresis |
| ID | Term |
|---|---|
| D011384 | Proinsulin |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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| plasmapheresis | Device | Triglyceridemia should be less than 5.65 mmol/l. |
|
| 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 |
| Clinical Severity Score | Apache2 | From admition to 7 days |
| D052439 |
| Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001781 | Blood Component Removal |
| D013812 | Therapeutics |
| D016060 | Sorption Detoxification |
| D005112 | Extracorporeal Circulation |
| D013514 | Surgical Procedures, Operative |