Comparing three early treatments for sudden-onset pancreatitis (inflammation of the pancreas) caused by high levels of fat in the blood

Not Applicable

Suspended

• Conditions: Hypertriglyceridemia-induced acute pancreatitis; Digestive System

• Registration Number: ISRCTN41530928
• Lead Sponsor: niversity of Pécs Medical School

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-12-10
• Last Update Posted: 18 May 2020
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: Suspended
• Sex: All
• Target Recruitment: 495

Inclusion Criteria

1. Aged 18-80 years
2. Diagnosed with AP on the basis of the '2 out of 3' criteria in the IAP/APA guidelines:
2.1. Upper abdominal pain
2.2. Serum amylase or lipase >3x upper limit of normal range
2.3. Characteristic findings on pancreatic imaging
3. HTG is diagnosed: if the blood TG level is at least 1000 mg/dl (11.3 mmol/l)
4. Signed informed consent

Exclusion Criteria

1. Pregnancy or breast feeding
2. Any of the interventions is not available within 48 h calculated from the start of abdominal pain
3. Any of the interventions can not be started within 12 h calculated from the venepuncture which provided the blood sample for HTG analysis
4. Coma
5. Malignancy
6. Early ARDS
7. Renal failure
8. Allergy to insulin or heparin
9. Chronic pancreatitis
10. Hospitalisation before admission
11. Any reasons contraindicating plasmapheresis: severe active bleeding or disseminated intravascular coagulation (hematocrit level <20%), other forms of coagulopathy; hemodynamic instability; potassium plasma levels <3.5 mEq/l, sepsis, allergy to albumin, chronic heart failure (NYHA Grade II or more or ejection fraction lower than 50%) or symptoms of fluid overload at recruitment or long QT syndrome

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Frequency of severe AP according to the revised Atlanta Classification measured by clinical assessment at discharge or mortality from admission to discharge<br> 1. Frequency of severe AP according to the revised Atlanta Classification, measured by clinical assessment at discharge<br> 2. Mortality, measured from admission to discharge, assessed daily during the study<br> These outcomes will be evaluated using yes/no questions as part of a questionnaire filled out by the doctor who examines the patients (who is not the doctor who made the randomisation).<br>