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
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Enteral nutrition | Same 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.