Enteral Nutrition for Treatment of Acute Pancreatitis - a Prospective, Randomized Clinical Trial
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Acute Pancreatitis
- Sponsor
- University Hospital Rijeka
- Enrollment
- 214
- Primary Endpoint
- SIRS (Systemic Inflammatory Response Syndrome)
- Status
- Completed
- Last Updated
- 11 years ago
Overview
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
Investigators
Goran Poropat
Medical doctor
University Hospital Rijeka
Eligibility 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
Outcomes
Primary Outcomes
SIRS (Systemic Inflammatory Response Syndrome)
Time Frame: 4 weeks
Secondary Outcomes
- Length of hospital stay(4 weeks)
- Inflammatory response (CRP on the first and third day)(First and third day of admission)
- All-cause mortality(4 weeks)
- Local complications (pancreatic necrosis, fluid collections, pseudocyst, abscess)(4 weeks)
- Other infections(4 weeks)
- Organ failure (cardiovascular, respiratory, renal)(4 weeks)
- Local septic complications(4 weeks)
- Adverse events(4 weeks)