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

November 14, 2017 updated by: Peking Union Medical College Hospital

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

220

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
serum TG
Time Frame: every 4 hours in first 3 days
Elimination of serum triglyceride.
every 4 hours in first 3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 1, 2017

Primary Completion (Anticipated)

November 1, 2019

Study Completion (Anticipated)

November 1, 2020

Study Registration Dates

First Submitted

November 5, 2017

First Submitted That Met QC Criteria

November 14, 2017

First Posted (Actual)

November 17, 2017

Study Record Updates

Last Update Posted (Actual)

November 17, 2017

Last Update Submitted That Met QC Criteria

November 14, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HTG-AP-Insulin

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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