Enteral Nutrition in Acute Pancreatitis

Acute Pancreatitis Clinical Trial

Official title: Enteral Nutrition for Treatment of Acute Pancreatitis - a Prospective, Randomized Clinical Trial

Status Completed

Clinical Trial 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

Clinical Trial 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 ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Pancreatitis
• Pancreatitis

• NCT number: NCT01965873
• Study type: Interventional
• Source: University Hospital Rijeka
• Status: Completed
• Phase: Phase 4
• Start date: May 2007
• Completion date: June 2012