Enteral Nutrition in Acute Pancreatitis

University Hospital Rijeka

Status and phase: Completed; Phase 4

Conditions: Acute Pancreatitis

Treatments: Dietary Supplement: Enteral nutrition

Study type: Interventional

Funder types: Other

Identifiers

NCT01965873

062-0000000-0211

Details and patient eligibility

About

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

Full 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

Enrollment: 214 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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214 participants in 2 patient groups

Enteral nutrition

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Enteral nutrition

Nil-by-mouth treatment

No Intervention group

Description:

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.