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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Unknown; Phase 4

Conditions: Hypertriglyceridemia; Pancreatitis, Acute

Treatments: Drug: Insulin; Device: Aphesis

Study type: Interventional

Funder types: Other

Identifiers

NCT03342807

HTG-AP-Insulin

Details and patient eligibility

About

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

Enrollment: 220 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

220 participants in 2 patient groups

Group Insulin

Experimental group

Treatment:

Drug: Insulin

Group Aphesis

Experimental group

Treatment:

Device: Aphesis