Clinical trial NCT03501680: Intensive Insulin for Severe/Moderate Hypertriglyceridemia Pancreatitis.
Official title: Randomized, Controlled, Open-label Trial of Intravenous Intensive Insulin for Severe/Moderate Hypertriglyceridemia Pancreatitis.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Acute Pancreatitis
Hypertriglyceridemia
Keywords: hyperlipidaemic pancreatitis
Plasmapheresis
insulin
Lead sponsor: First Affiliated Hospital of Wenzhou Medical University
Sponsor class: OTHER
First posted: 2018-04-18
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Reduction of mortality
timeFrame: From admition to hospital discharge, an average of 2 months
measure: Reduction of organ failure
timeFrame: From admition to hospital discharge, an average of 2 months
measure: triglyceride levels
timeFrame: From admition to hospital discharge, an average of 2 months
Secondary outcomes:
measure: cytokines in serum, urine
timeFrame: From admition to 7 days
measure: insulin dose
timeFrame: From admition to 7 days
measure: Severity Score in CT scan
timeFrame: From admition to 7 days
measure: TNF-α in serum, urine
timeFrame: From admition to 7 days
measure: Clinical Severity Score
timeFrame: From admition to 7 days
Other outcomes:
measure: Genomics
timeFrame: From admition to 7 days
measure: Clinical Severity Score
timeFrame: From admition to 7 days
measure: Clinical Severity Score
timeFrame: From admition to 7 days
Locations:
Study officials:
affiliation: The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China
name: Meng-Tao Zhou, M.D.
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.