Enteral Nutrition in Acute Pancreatitis
- Conditions
- Acute Pancreatitis
- Interventions
- Dietary Supplement: Enteral nutrition
- Registration Number
- NCT01965873
- Lead Sponsor
- University Hospital Rijeka
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 214
- 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
- patients < 18 years of age
- pregnant and breastfeeding women
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Enteral nutrition Enteral nutrition In the enteral nutrition group a nasojejunal feeding tube will be placed via esophagogastroduodenoscopy and the position confirmed radiographically. Nutritional support will be started within 24 hours of enrollment, supplying daily 105 kJ (25 kcal)/kg, and 1.5 g/kg of protein based on ideal body weight. An elemental product for enteral nutrition will be infused at a rate of 25 ml/h, and increased by 10 ml/h every 6 hours, until the target rate of 100 ml/h will be achieved within 24-48 hours.
- Primary Outcome Measures
Name Time Method SIRS (Systemic Inflammatory Response Syndrome) 4 weeks
- Secondary Outcome Measures
Name Time Method 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 Length of hospital stay 4 weeks