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

Sponsor

Peking Union Medical College Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT03342807

Collaborator

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

220

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Pancreatitis, Acute Hypertriglyceridemia	Drug: Insulin Device: Aphesis	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

220 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Nov 1, 2017

Anticipated Primary Completion Date :

Nov 1, 2019

Anticipated Study Completion Date :

Nov 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group Insulin	Drug: Insulin Insulin infusion for subjects in Group Insulin.
Experimental: Group Aphesis	Device: Aphesis Aphesis for subjects in Group Aphesis.

Arm

Intervention/Treatment

Experimental: Group Insulin

Drug: Insulin

Insulin infusion for subjects in Group Insulin.

Experimental: Group Aphesis

Device: Aphesis

Aphesis for subjects in Group Aphesis.

Outcome Measures

Primary Outcome Measures

serum TG [every 4 hours in first 3 days]
Elimination of serum triglyceride.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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