Enteral Nutrition in Acute Pancreatitis

Acute Pancreatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01965873
• Other study ID #: 062-0000000-0211
• Status: Completed
• Phase: Phase 4
• First received: October 16, 2013
• Last updated: March 30, 2015
• Start date: May 2007
• Est. completion date: June 2012

Study information

• Verified date: March 2015
• Source: University Hospital Rijeka
• Contact: n/a
• Is FDA regulated: No
• Health authority: Croatia: Ethics Committee
• Study type: Interventional

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 214
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Intervention

Dietary Supplement:
• Enteral nutrition
Same as arm description

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Rijeka

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SIRS (Systemic Inflammatory Response Syndrome)		4 weeks	No
Secondary	All-cause mortality		4 weeks	No
Secondary	Organ failure (cardiovascular, respiratory, renal)		4 weeks	No
Secondary	Local complications (pancreatic necrosis, fluid collections, pseudocyst, abscess)		4 weeks	No
Secondary	Local septic complications		4 weeks	No
Secondary	Other infections		4 weeks	No
Secondary	Inflammatory response (CRP on the first and third day)		First and third day of admission	No
Secondary	Length of hospital stay		4 weeks	No
Secondary	Adverse events		4 weeks	Yes