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OpenTrials
Completed

NCT Number: NCT01965873

Enteral Nutrition in Acute Pancreatitis

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

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Key information

Conditions

Acute Pancreatitis Behavior Digestive System Diseases Fasting Feeding Behavior Pancreatic Diseases Pancreatitis Pancreatitis, Acute Necrotizing

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Enteral Nutrition

Dietary Supplement

Same as arm description

Primary outcomes

  1. SIRS (Systemic Inflammatory Response Syndrome)

    Time frame: 4 weeks

Secondary outcomes

  1. All-cause mortality

    Time frame: 4 weeks

  2. Organ failure (cardiovascular, respiratory, renal)

    Time frame: 4 weeks

  3. Local complications (pancreatic necrosis, fluid collections, pseudocyst, abscess)

    Time frame: 4 weeks

  4. Local septic complications

    Time frame: 4 weeks

  5. Other infections

    Time frame: 4 weeks

  6. Inflammatory response (CRP on the first and third day)

    Time frame: First and third day of admission

  7. Length of hospital stay

    Time frame: 4 weeks

  8. Adverse events

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

University Hospital Rijeka

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2012
Study completion
2012
First posted
Oct 18, 2013
Registry last updated
Apr 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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