Hypertriglyceridemia-associated Acute Pancreatitis: Apheresis Vs. Conservative Treatment

NCT04708925 | Completed

• 1 other identifier: 0350-19-MMC
• Study Type: observational
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction: Hypertriglyceridemia is one of the etiologies of acute pancreatitis. It may cause severe multi-system disease resulting in high morbidity and mortality. There is controversy regarding the best method to treat it, which includes, among other therapies, high-dose insulin and performing plasma exchange (apheresis). Aims: Primary outcome - Comparison of 28- day mortality between hypertriglyceridemia-induced acute pancreatitis patients who received conservative therapy versus those who received apheresis therapy. Secondary outcomes: Comparison of morbidity parameters and rate of blood triglycerides level decrease between the groups. Materials and Methods: A retrospective study based on observational data collection, which will include all patients aged 18--99 who were admitted to the intensive care unit in 2010-2020 in the diagnosis of acute pancreatitis secondary to high blood lipids. Data will be collected from hospital files and computerized systems. Data will include demographics, admission times, ventilation days, pressor support, 28- day mortality,daily triglyceride level, medical history, APACHE-2 score, lactate level, need for dialysis, need for antibiotics and surgical intervention. The study will include 29 patients. All demographic and patient parameters will be statistically examined by a qualified statistician depending on the type of data.

Conditions

Acute Pancreatitis

Outcome Measures

Primary Outcomes (1)

• 28-day mortality

  mortality within 28 days from ICU admission

  28 days

Study Arms (2)

group A- conservative therpay

hypertriglyceridemia-induced acute pancreatitis patients who recieved conservative therapy

group B- plasmapharesis therapy

hypertriglyceridemia-induced acute pancreatitis patients who recieved plasmapharesis therapy

Other: conservative versus plasmapharesis therapy

Interventions

conservative versus plasmapharesis therapy OTHER

conservative versus plasmapharesis therapy

group B- plasmapharesis therapy

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients aged 18-99 who were admitted to the intensive care unit in Meir medical hospital between years 2010-2020, whose cause of admission was hypertriglyceridemia-induced acute pancreatitis, defined as abdominal pain, elevated levels of amylase and lipase and blood triglyceride level above 1000 mg/dl, without any other apparent etiology of pancreatitis. \-

Sponsors & Collaborators

• Meir Medical Center: lead

Study Sites (1)

Meir Medical Center

Kfar Saba, Israel

Location

MeSH Terms

Conditions

Pancreatitis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases

Study Officials

• Sara Dichtwald, MD

  Meir Medical Center

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: January 12, 2021
• First Posted: January 14, 2021
• Study Start: February 1, 2021
• Primary Completion: October 1, 2021
• Study Completion: October 1, 2021
• Last Updated: April 13, 2022

Record last verified: 2022-04

Locations

IL (1)