Intravenous Administration of Insulin and Plasma Exchange on Triglyceride Levels in Early Stage of Hypertriglyceridemia-induced Pancreatitis

Hypertriglyceridemia Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03342807
• Other study ID #: HTG-AP-Insulin
• Status: Not yet recruiting
• Phase: Phase 4
• First received: November 5, 2017
• Last updated: November 14, 2017
• Start date: November 2017
• Est. completion date: November 2020

Study information

• Verified date: August 2017
• Source: Peking Union Medical College Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 220
• Est. completion date: November 2020
• Est. primary completion date: November 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypertriglyceridemia
• Pancreatitis
• Pancreatitis, Acute

Intervention

Drug:
• Insulin
Insulin infusion for subjects in Group Insulin.

Device:
• Aphesis
Aphesis for subjects in Group Aphesis.

Locations

Country	Name	City	State
n/a

Sponsors (16)

Lead Sponsor

Collaborator

Peking Union Medical College Hospital

Cangzhou Center Hospital, First Affiliated Hospital of Kunming Medical College, First Affiliated Hospital, Sun Yat-Sen University, First Hospitals affiliated to the China PLA General Hospital, Fujian Provincial Hospital Emergency Center, General Hospital of Ningxia Medical University, Guangdong Provincial Hospital of Traditional Chinese Medicine, Jinhua Central Hospital, Nanjing General Hospital, Shenzhen Baoan District People 's Hospital, The First Affiliated Hospital with Nanjing Medical University, The First Hospital of Hebei Medical College, The General Hospital of Shenyang Military, Tianjin Medical University General Hospital, Wuxi Third People 's Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	serum TG	Elimination of serum triglyceride.	every 4 hours in first 3 days