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