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Intensive Insulin for Severe/Moderate Hypertriglyceridemia Pancreatitis. (HAPinsulin)

Primary Purpose

Acute Pancreatitis, Hypertriglyceridemia

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Insulin
plasmapheresis
Sponsored by
First Affiliated Hospital of Wenzhou Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Pancreatitis focused on measuring hyperlipidaemic pancreatitis, Plasmapheresis, insulin

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Active Comparator

    Active Comparator

    Arm Label

    Group A: intensive insulin

    Group B: standard insulin

    Group C: plasmapheresis

    Arm Description

    Group A: intensive insulin (glycemic control 4.4-6.1mmol/L)

    Group B: standard insulin (glycemic control 7.8-10.0 mmol/L),

    Group C: plasmapheresis

    Outcomes

    Primary Outcome Measures

    Reduction of mortality
    Number of participants with fatal outcome during hospitalisation
    Reduction of organ failure
    reanl failure, respiratory failure, circulatory failure etal
    triglyceride levels
    triglyceride levels

    Secondary Outcome Measures

    cytokines in serum, urine
    IL-6, IL-8, IL-10
    insulin dose
    insulin dose
    Severity Score in CT scan
    CT Balthazar score/grade or MCTSI score
    TNF-α in serum, urine
    TNF-α
    Clinical Severity Score
    BISAP score

    Full Information

    First Posted
    March 29, 2018
    Last Updated
    June 4, 2018
    Sponsor
    First Affiliated Hospital of Wenzhou Medical University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03501680
    Brief Title
    Intensive Insulin for Severe/Moderate Hypertriglyceridemia Pancreatitis.
    Acronym
    HAPinsulin
    Official Title
    Randomized, Controlled, Open-label Trial of Intravenous Intensive Insulin for Severe/Moderate Hypertriglyceridemia Pancreatitis.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 6, 2018 (Anticipated)
    Primary Completion Date
    March 8, 2020 (Anticipated)
    Study Completion Date
    December 31, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    First Affiliated Hospital of Wenzhou Medical University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    Yes
    Device Product Not Approved or Cleared by U.S. FDA
    Yes
    Product Manufactured in and Exported from the U.S.
    Yes
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acute Pancreatitis, Hypertriglyceridemia
    Keywords
    hyperlipidaemic pancreatitis, Plasmapheresis, insulin

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    200 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Group A: intensive insulin
    Arm Type
    Experimental
    Arm Description
    Group A: intensive insulin (glycemic control 4.4-6.1mmol/L)
    Arm Title
    Group B: standard insulin
    Arm Type
    Active Comparator
    Arm Description
    Group B: standard insulin (glycemic control 7.8-10.0 mmol/L),
    Arm Title
    Group C: plasmapheresis
    Arm Type
    Active Comparator
    Arm Description
    Group C: plasmapheresis
    Intervention Type
    Drug
    Intervention Name(s)
    Insulin
    Intervention Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    plasmapheresis
    Intervention Description
    Triglyceridemia should be less than 5.65 mmol/l.
    Primary Outcome Measure Information:
    Title
    Reduction of mortality
    Description
    Number of participants with fatal outcome during hospitalisation
    Time Frame
    From admition to hospital discharge, an average of 2 months
    Title
    Reduction of organ failure
    Description
    reanl failure, respiratory failure, circulatory failure etal
    Time Frame
    From admition to hospital discharge, an average of 2 months
    Title
    triglyceride levels
    Description
    triglyceride levels
    Time Frame
    From admition to hospital discharge, an average of 2 months
    Secondary Outcome Measure Information:
    Title
    cytokines in serum, urine
    Description
    IL-6, IL-8, IL-10
    Time Frame
    From admition to 7 days
    Title
    insulin dose
    Description
    insulin dose
    Time Frame
    From admition to 7 days
    Title
    Severity Score in CT scan
    Description
    CT Balthazar score/grade or MCTSI score
    Time Frame
    From admition to 7 days
    Title
    TNF-α in serum, urine
    Description
    TNF-α
    Time Frame
    From admition to 7 days
    Title
    Clinical Severity Score
    Description
    BISAP score
    Time Frame
    From admition to 7 days
    Other Pre-specified Outcome Measures:
    Title
    Genomics
    Description
    cfDNA et.al.
    Time Frame
    From admition to 7 days
    Title
    Clinical Severity Score
    Description
    Ranson score
    Time Frame
    From admition to 7 days
    Title
    Clinical Severity Score
    Description
    Apache2
    Time Frame
    From admition to 7 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    KeQing Shi, M.D.
    Phone
    (086)15858515296
    Email
    skochilly@163.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Meng-Tao Zhou, M.D.
    Organizational Affiliation
    The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    22201145
    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.
    Results Reference
    background
    PubMed Identifier
    19293788
    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.
    Results Reference
    background

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    Intensive Insulin for Severe/Moderate Hypertriglyceridemia Pancreatitis.

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