Enteral Nutrition in Acute Pancreatitis

March 30, 2015 updated by: Goran Poropat, University Hospital Rijeka

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

214

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Enteral nutrition
In the enteral nutrition group a nasojejunal feeding tube will be placed via esophagogastroduodenoscopy and the position confirmed radiographically. Nutritional support will be started within 24 hours of enrollment, supplying daily 105 kJ (25 kcal)/kg, and 1.5 g/kg of protein based on ideal body weight. An elemental product for enteral nutrition will be infused at a rate of 25 ml/h, and increased by 10 ml/h every 6 hours, until the target rate of 100 ml/h will be achieved within 24-48 hours.
Dietary supplement: Enteral nutrition
Same as arm description
No Intervention: Nil-by-mouth treatment
The nil-by-mouth treatment consists intravenous fluid replacement according to assessed needs via peripheral veins. This will include crystalloid (0.9% saline and 5% glucose), and colloid (10% hydroxyethyl starch and 3.5% plasma expander - haemaccel) solutions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
SIRS (Systemic Inflammatory Response Syndrome)
Time Frame: 4 weeks
4 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Rijeka

Investigators

  • Principal Investigator: Davor Štimac, MD, PhD, Department of Gastroenterology, University Hospital Rijeka

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

October 16, 2013

First Submitted That Met QC Criteria

October 17, 2013

First Posted (Estimate)

October 18, 2013

Study Record Updates

Last Update Posted (Estimate)

April 3, 2015

Last Update Submitted That Met QC Criteria

March 30, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 062-0000000-0211

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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