Clinical Trials Directory

Trials / Completed

CompletedNCT01965873

Enteral Nutrition in Acute Pancreatitis

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

Status
Completed
Phase
Phase 4
Study type
Interventional
Enrollment
214 (actual)
Sponsor
University Hospital Rijeka · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTEnteral nutritionSame as arm description

Timeline

Start date
2007-05-01
Primary completion
2012-06-01
Completion
2012-06-01
First posted
2013-10-18
Last updated
2015-04-03

Source: ClinicalTrials.gov record NCT01965873. Inclusion in this directory is not an endorsement.