Back to resultsIntravenous Administration of Insulin and Plasma Exchange on Triglyceride Levels in Early Stage of Hypertriglyceridemia-induced Pancreatitis
Primary Purpose
Pancreatitis, Acute, Hypertriglyceridemia
Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Insulin
Aphesis
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatitis, Acute focused on measuring Hypertriglyceridemia-induced acute pancreatitis, insulin, triglyceride, treatment
Eligibility Criteria
Inclusion Criteria:
- Adult aged 18 to 80 years old;
- abdominal pain consistent with AP;
- serum amylase and / or lipase activity is at least 3 times higher than the normal upper limit;
- abdominal imaging consistent with AP imaging changes.
- severe hyperlipidemia "fasting serum TG> 1,000 mg/dL (11.2mmol/L)";
- except for other AP causes, such as cholelithiasis, alcohol, drugs and so on.
Exclusion Criteria:
- other etiologies other than hyperlipidemia leading to AP;
- fasting serum TG less than 1,000 mg / dL (11.2mmol / L);
- acute lipid-induced pancreatitis at the same time combined with other etiologies of acute pancreatitis.
- the existence of plasma replacement contraindications: serious allergies to plasma, human serum albumin, heparin and others; the existence of mental disorders; unstable heart or cerebral infarction; intracranial hemorrhage or severe cerebral edema associated with hernia.
- 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 Type
Experimental
Experimental
Arm Label
Group Insulin
Group Aphesis
Arm Description
Outcomes
Primary Outcome Measures
serum TG
Elimination of serum triglyceride.
Secondary Outcome Measures
Full Information
NCT ID
NCT03342807
First Posted
November 5, 2017
Last Updated
November 14, 2017
Sponsor
Peking Union Medical College Hospital
Collaborators
First Hospitals affiliated to the China PLA General Hospital, Nanjing General Hospital, Fujian Provincial Hospital Emergency Center, First Affiliated Hospital, Sun Yat-Sen University, Jinhua Central Hospital, Guangdong Provincial Hospital of Traditional Chinese Medicine, First Affiliated Hospital of Kunming Medical University, Tianjin Medical University General Hospital, The First Hospital of Hebei Medical College, The First Affiliated Hospital with Nanjing Medical University, Shenzhen Baoan District People 's Hospital, The General Hospital of Shenyang Military, Cangzhou Center Hospital, Wuxi Third People 's Hospital, General Hospital of Ningxia Medical University
1. Study Identification
Unique Protocol Identification Number
NCT03342807
Brief Title
Intravenous Administration of Insulin and Plasma Exchange on Triglyceride Levels in Early Stage of Hypertriglyceridemia-induced Pancreatitis
Official Title
Randomized, Controlled, Multicenter Studies of the Effects of Intravenous Administration of Insulin and Plasma Exchange on Triglyceride Levels in Early Stage of Hypertriglyceridemia-induced Pancreatitis
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Unknown status
Study Start Date
November 2017 (Anticipated)
Primary Completion Date
November 2019 (Anticipated)
Study Completion Date
November 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking Union Medical College Hospital
Collaborators
First Hospitals affiliated to the China PLA General Hospital, Nanjing General Hospital, Fujian Provincial Hospital Emergency Center, First Affiliated Hospital, Sun Yat-Sen University, Jinhua Central Hospital, Guangdong Provincial Hospital of Traditional Chinese Medicine, First Affiliated Hospital of Kunming Medical University, Tianjin Medical University General Hospital, The First Hospital of Hebei Medical College, The First Affiliated Hospital with Nanjing Medical University, Shenzhen Baoan District People 's Hospital, The General Hospital of Shenyang Military, Cangzhou Center Hospital, Wuxi Third People 's Hospital, General Hospital of Ningxia Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief Summary
To investigate an economical and effective way to reduce the level of serum triglyceride in patients with hypertriglyceridemia-induced acute pancreatitis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatitis, Acute, Hypertriglyceridemia
Keywords
Hypertriglyceridemia-induced acute pancreatitis, insulin, triglyceride, treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
220 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group Insulin
Arm Type
Experimental
Arm Title
Group Aphesis
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Insulin
Intervention Description
Insulin infusion for subjects in Group Insulin.
Intervention Type
Device
Intervention Name(s)
Aphesis
Intervention Description
Aphesis for subjects in Group Aphesis.
Primary Outcome Measure Information:
Title
serum TG
Description
Elimination of serum triglyceride.
Time Frame
every 4 hours in first 3 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult aged 18 to 80 years old;
abdominal pain consistent with AP;
serum amylase and / or lipase activity is at least 3 times higher than the normal upper limit;
abdominal imaging consistent with AP imaging changes.
severe hyperlipidemia "fasting serum TG> 1,000 mg/dL (11.2mmol/L)";
except for other AP causes, such as cholelithiasis, alcohol, drugs and so on.
Exclusion Criteria:
other etiologies other than hyperlipidemia leading to AP;
fasting serum TG less than 1,000 mg / dL (11.2mmol / L);
acute lipid-induced pancreatitis at the same time combined with other etiologies of acute pancreatitis.
the existence of plasma replacement contraindications: serious allergies to plasma, human serum albumin, heparin and others; the existence of mental disorders; unstable heart or cerebral infarction; intracranial hemorrhage or severe cerebral edema associated with hernia.
without informed consent, the patient refused to plasma replacement, and other circumstances may bring significant bias.
12. IPD Sharing Statement
Citations:
PubMed Identifier
31215460
Citation
Song X, Shi D, Cui Q, Yu S, Yang J, Song P, Walline J, Xu J, Zhu H, Yu X. Intensive insulin therapy versus plasmapheresis in the management of hypertriglyceridemia-induced acute pancreatitis (Bi-TPAI trial): study protocol for a randomized controlled trial. Trials. 2019 Jun 18;20(1):365. doi: 10.1186/s13063-019-3498-x.
Results Reference
derived
Learn more about this trial
Intravenous Administration of Insulin and Plasma Exchange on Triglyceride Levels in Early Stage of Hypertriglyceridemia-induced Pancreatitis
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