Clinical Trial: Enteral Nutrition in Acute Pancreatitis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary:

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

Sponsor: University Hospital Rijeka

Current Primary Outcome: SIRS (Systemic Inflammatory Response Syndrome) [ Time Frame: 4 weeks ]

Original Primary Outcome: All-cause mortality [ Time Frame: 4 weeks ]

Current Secondary Outcome:

  • All-cause mortality [ Time Frame: 4 weeks ]
  • Organ failure (cardiovascular, respiratory, renal) [ Time Frame: 4 weeks ]
  • Local complications (pancreatic necrosis, fluid collections, pseudocyst, abscess) [ Time Frame: 4 weeks ]
  • Local septic complications [ Time Frame: 4 weeks ]
  • Other infections [ Time Frame: 4 weeks ]
  • Inflammatory response (CRP on the first and third day) [ Time Frame: First and third day of admission ]
  • Length of hospital stay [ Time Frame: 4 weeks ]
  • Adverse events [ Time Frame: 4 weeks ]


Original Secondary Outcome:

  • Systemic complications (respiratory, renal, and/or cardiovascular failure) [ Time Frame: 4 weeks ]
  • Local complications (pancreatic necrosis, fluid collections, pseudocyst, abscess) [ Time Frame: 4 weeks ]
  • SIRS (Systemic inflammatory response syndrome) [ Time Frame: 4 weeks ]
  • Inflammatory response (CRP) [ Time Frame: 4 weeks ]
  • Length of hospital stay [ Time Frame: 4 weeks ]
  • Adverse events [ Time Frame: 4 weeks ]


Information By: University Hospital Rijeka

Dates:
Date Received: October 16, 2013
Date Started: May 2007
Date Completion:
Last Updated: March 30, 2015
Last Verified: March 2015