Acute Pancreatitis
Conditions
Keywords
Pancreatitis, Acute necrotizing, Enteral nutrition, Fasting, Complications, Mortality
Brief summary
The purpose of this prospective randomised clinical trial is to compare beneficial and harmful effects of the use enteral nutrition versus a nil-by-mouth and intravenous fluid replacement principle of treatment in patients with moderate to severe acute pancreatitis (AP). The hypothesis: * enteral nutrition is no significantly better compared with the nil-by-mouth principle regarding mortality, incidence of local and systemic complications, length of hospital stay, and intensity of the inflammatory response in patients with moderate to severe AP * enteral nutrition has the same safety as nil-by-mouth principle in patients with moderate to severe AP
Detailed description
Patients with first attack of AP irrespective of etiology will be enrolled in the study, if they are eligible according to the following criteria: Inclusion criteria: * onset of symptoms consistent with AP within 72 hours before admission to the hospital * an 3-fold elevation of serum amylase or serum lipase over the upper limit of normal * APACHE II score 6 or more * a signed informed consent Exclusion criteria: * patients \< 18 years of age * pregnant and breastfeeding women
Interventions
DIETARY_SUPPLEMENTEnteral nutrition
Same as arm description
Sponsors
University Hospital Rijeka
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* onset of symptoms consistent with AP within 72 hours before admission to the hospital * an 3-fold elevation of serum amylase or serum lipase over the upper limit of normal * APACHE II score 6 or more * a signed informed consent
Exclusion criteria
* patients \< 18 years of age * pregnant and breastfeeding women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| SIRS (Systemic Inflammatory Response Syndrome) | 4 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Organ failure (cardiovascular, respiratory, renal) | 4 weeks |
| Local complications (pancreatic necrosis, fluid collections, pseudocyst, abscess) | 4 weeks |
| Local septic complications | 4 weeks |
| All-cause mortality | 4 weeks |
| Inflammatory response (CRP on the first and third day) | First and third day of admission |
| Length of hospital stay | 4 weeks |
| Adverse events | 4 weeks |
| Other infections | 4 weeks |
Outcome results
None listed