Clinical trial NCT03342807: 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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Pancreatitis, Acute
Hypertriglyceridemia
Keywords: Hypertriglyceridemia-induced acute pancreatitis
insulin
triglyceride
treatment
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
Collaborators: name: First Hospitals affiliated to the China PLA General Hospital
name: Nanjing General Hospital
name: Fujian Provincial Hospital Emergency Center
name: First Affiliated Hospital, Sun Yat-Sen University
name: Jinhua Central Hospital
name: Guangdong Provincial Hospital of Traditional Chinese Medicine
name: First Affiliated Hospital of Kunming Medical University
name: Tianjin Medical University General Hospital
name: The First Hospital of Hebei Medical College
name: The First Affiliated Hospital with Nanjing Medical University
name: Shenzhen Baoan District People 's Hospital
name: The General Hospital of Shenyang Military
name: Cangzhou Center Hospital
name: Wuxi Third People 's Hospital
name: General Hospital of Ningxia Medical University
First posted: 2017-11-17
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To investigate an economical and effective way to reduce the level of serum triglyceride in patients with hypertriglyceridemia-induced acute pancreatitis.


Eligibility criteria: Inclusion Criteria:

1. Adult aged 18 to 80 years old;
2. abdominal pain consistent with AP;
3. serum amylase and / or lipase activity is at least 3 times higher than the normal upper limit;
4. abdominal imaging consistent with AP imaging changes.
5. severe hyperlipidemia "fasting serum TG\> 1,000 mg/dL (11.2mmol/L)";
6. except for other AP causes, such as cholelithiasis, alcohol, drugs and so on.

Exclusion Criteria:

1. other etiologies other than hyperlipidemia leading to AP;
2. fasting serum TG less than 1,000 mg / dL (11.2mmol / L);
3. acute lipid-induced pancreatitis at the same time combined with other etiologies of acute pancreatitis.
4. 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.
5. without informed consent, the patient refused to plasma replacement, and other circumstances may bring significant bias.

Primary outcomes:
measure: serum TG
timeFrame: every 4 hours in first 3 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
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.