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

• Register: ChiCTR
• Last refreshed on: 11 September 2017
• Main ID: ChiCTR-IIR-17012614
• Date of registration: 2017-09-08
• Prospective Registration: Yes
• Primary sponsor: Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
• Public 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
• Scientific 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
• Date of first enrolment: 2017-09-11
• Target sample size: Group Insulin:110;Group Aphesis:110;
• Recruitment status: Recruiting
• URL: http://www.chictr.org.cn/showproj.aspx?proj=21483
• Study type: Interventional study
• Study design: Randomized parallel controlled trial
• Phase: IV (Phase IV study)

Countries of recruitment

China

Contacts

• Name: Huadong Zhu
• Affiliation: Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College

• Name: Xiao Song
• Affiliation: Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College

Key inclusion & exclusion 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.

Age minimum: 18
Age maximum: 80
Gender: Both

Health Condition(s) or Problem(s) studied

acute hypertriglyceridemia-induced pancreatitis

Intervention(s)

Group Insulin:insulin infusion;Group Aphesis:Aphesis;

Primary Outcome(s)

serum TG;

Secondary Outcome(s)

IL-6;IL-8;IL-10;TNF-a;hsCRP;ESR;Amylase;lipase;

Source(s) of Monetary Support

No