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

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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03342807
Enrollment
220
Registered
2017-11-17
Start date
2017-11-30
Completion date
2020-11-30
Last updated
2017-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertriglyceridemia, Pancreatitis, Acute

Keywords

Hypertriglyceridemia-induced acute pancreatitis, insulin, triglyceride, treatment

Brief summary

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

Interventions

DRUGInsulin

Insulin infusion for subjects in Group Insulin.

DEVICEAphesis

Aphesis for subjects in Group Aphesis.

Sponsors

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

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
serum TGevery 4 hours in first 3 daysElimination of serum triglyceride.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026