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

Phase 4

• Conditions: Pancreatitis, Acute; Hypertriglyceridemia
• Interventions: Drug: Insulin; Device: Aphesis

• Registration Number: NCT03342807
• Lead Sponsor: Peking Union Medical College Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-08
• Study Start: 2017-11
• Study First Submitted: 2017-11-05
• Study First Submitted QC: 2017-11-14
• Last Update Submitted: 2017-11-14
• Study First Posted: 2017-11-17
• Last Update Posted: 2017-11-17
• Primary Completion: 2019-11
• Study Completion: 2020-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 220

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group Insulin	Insulin	-
Group Aphesis	Aphesis	-

Primary Outcome Measures

Name	Time	Method
serum TG	every 4 hours in first 3 days	Elimination of serum triglyceride.