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

NCT03342807 | Unknown Phase 4 FDA Drug FDA Device

• 1 other identifier: HTG-AP-Insulin
• Study Type: interventional
• Target: 220
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Pancreatitis, Acute; Hypertriglyceridemia

Keywords

Hypertriglyceridemia-induced acute pancreatitis; insulin; triglyceride; treatment

Outcome Measures

Primary Outcomes (1)

• serum TG

  Elimination of serum triglyceride.

  every 4 hours in first 3 days

Study Arms (2)

Group Insulin

EXPERIMENTAL

Drug: Insulin

Group Aphesis

EXPERIMENTAL

Device: Aphesis

Interventions

Insulin DRUG

Insulin infusion for subjects in Group Insulin.

Group Insulin

Aphesis DEVICE

Aphesis for subjects in Group Aphesis.

Group Aphesis

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Related Publications (1)

• Song X, Shi D, Cui Q, Yu S, Yang J, Song P, Walline J, Xu J, Zhu H, Yu X. Intensive insulin therapy versus plasmapheresis in the management of hypertriglyceridemia-induced acute pancreatitis (Bi-TPAI trial): study protocol for a randomized controlled trial. Trials. 2019 Jun 18;20(1):365. doi: 10.1186/s13063-019-3498-x.

  PMID: 31215460 DERIVED

MeSH Terms

Conditions

Pancreatitis; Hypertriglyceridemia; Insulin Resistance

Interventions

Insulin

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Hyperinsulinism; Glucose Metabolism Disorders

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2017
• First Posted: November 17, 2017
• Study Start: November 1, 2017
• Primary Completion: November 1, 2019
• Study Completion: November 1, 2020
• Last Updated: November 17, 2017

Record last verified: 2017-08