Enteral Nutrition in Acute Pancreatitis

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Acute Pancreatitis

Intervention / Treatment
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* Dietary Supplement: Enteral nutrition


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Enteral nutrition<br>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<br>* Same as arm description<br>|
| No Intervention: Nil-by-mouth treatment<br>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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SIRS (Systemic Inflammatory Response Syndrome) |  | 4 weeks | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pancreatitis, Acute necrotizing, Enteral nutrition, Fasting, Complications, Mortality