Clinical trial NCT01965873: Enteral Nutrition in Acute Pancreatitis
Official title: Enteral Nutrition for Treatment of Acute Pancreatitis - a Prospective, Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Pancreatitis
Keywords: Pancreatitis, Acute necrotizing
Enteral nutrition
Fasting
Complications
Mortality
Lead sponsor: University Hospital Rijeka
Sponsor class: OTHER
First posted: 2013-10-18
Enrollment: 214
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: SIRS (Systemic Inflammatory Response Syndrome)
timeFrame: 4 weeks
Secondary outcomes:
measure: All-cause mortality
timeFrame: 4 weeks
measure: Organ failure (cardiovascular, respiratory, renal)
timeFrame: 4 weeks
measure: Local complications (pancreatic necrosis, fluid collections, pseudocyst, abscess)
timeFrame: 4 weeks
measure: Local septic complications
timeFrame: 4 weeks
measure: Other infections
timeFrame: 4 weeks
measure: Inflammatory response (CRP on the first and third day)
timeFrame: First and third day of admission
measure: Length of hospital stay
timeFrame: 4 weeks
measure: Adverse events
timeFrame: 4 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Department of Gastroenterology, University Hospital Rijeka
name: Davor Štimac, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stimac D, Poropat G, Hauser G, Licul V, Franjic N, Valkovic Zujic P, Milic S. Early nasojejunal tube feeding versus nil-by-mouth in acute pancreatitis: A randomized clinical trial. Pancreatology. 2016 Jul-Aug;16(4):523-8. doi: 10.1016/j.pan.2016.04.003. Epub 2016 Apr 13.