Hypertriglyceridemia-induced acute pancreatitis Digestive System
Conditions
Interventions
The randomization list will be generated by a computer programme. Information of randomization will be placed in sealed envelopes. The sequence of distribution will be prepared with variable block len
Sponsors
University of Pécs Medical School
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency of severe AP according to the revised Atlanta Classification measured by clinical assessment at discharge or mortality from admission to discharge 1. Frequency of severe AP according to the revised Atlanta Classification, measured by clinical assessment at discharge 2. Mortality, measured from admission to discharge, assessed daily during the study 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). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Serum triglyceride level measured by standard laboratory test daily during the study 2. Serum albumin level measured by standard laboratory test daily during the study 3. Serum calcium level measured by standard laboratory test daily during the study 4. Pain assessed using a visual analog scale at 1, 2 and 3 days after randomization 5. C-reactive protein (CRP) serum levels measured by standard laboratory test daily during the study 6. Leukocyte count measured by standard laboratory test daily during the study 7. Length of hospital stay in days assessed daily during clinical visits 8. Need for ICU admission measured at admission and daily during the study, based on the state of the patients at physical examination, mental state, vital parameters (blood pressure, pulse, O2 saturation) and laboratory parameters (e.g. blood urea nitrogen [BUN], creatinine) 9. Length of ICU stay in days assessed daily during clinical visits 10. Organ failure (divided into transient and persistent organ failure) measured at admission and daily during the study according to the revised Atlanta Classification 11. Complications of plasmapheresis measured at admission and daily during the study, by clinical assessment 12. Healthcare cost spent on each patient will be calculated by a healthcare economist after the trial is completed | — |
Countries
Germany, Hungary, Spain
Outcome results
None listed