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Enteral Nutrition in Acute Pancreatitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01965873
Recruitment Status : Completed
First Posted : October 18, 2013
Last Update Posted : April 3, 2015
Sponsor:
Information provided by (Responsible Party):
Goran Poropat, University Hospital Rijeka

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

Condition or disease Intervention/treatment Phase
Acute Pancreatitis Dietary Supplement: Enteral nutrition Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 214 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Enteral Nutrition for Treatment of Acute Pancreatitis - a Prospective, Randomized Clinical Trial
Study Start Date : May 2007
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pancreatitis

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.



Primary Outcome Measures :
  1. SIRS (Systemic Inflammatory Response Syndrome) [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01965873


Sponsors and Collaborators
University Hospital Rijeka
Investigators
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Principal Investigator: Davor Štimac, MD, PhD Department of Gastroenterology, University Hospital Rijeka
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Goran Poropat, Medical doctor, University Hospital Rijeka
ClinicalTrials.gov Identifier: NCT01965873    
Other Study ID Numbers: 062-0000000-0211
First Posted: October 18, 2013    Key Record Dates
Last Update Posted: April 3, 2015
Last Verified: March 2015
Keywords provided by Goran Poropat, University Hospital Rijeka:
Pancreatitis, Acute necrotizing
Enteral nutrition
Fasting
Complications
Mortality
Additional relevant MeSH terms:
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Pancreatitis
Pancreatic Diseases
Digestive System Diseases