Enteral Nutrition in Acute Pancreatitis

NCT ID: NCT01965873

Last Updated: 2015-04-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 214 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-05-31
• Study Completion Date: 2012-06-30

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

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

Conditions

Acute Pancreatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Enteral nutrition

Intervention Type: DIETARY_SUPPLEMENT

Same as arm description

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Enteral nutrition

Same as arm description

Intervention Type: DIETARY_SUPPLEMENT

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Rijeka

OTHER

Sponsor Role: lead

Responsible Party

Goran Poropat

Medical doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Davor Štimac, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Gastroenterology, University Hospital Rijeka

References

Stimac D, Poropat G, Hauser G, Licul V, Franjic N, Valkovic Zujic P, Milic S. Early nasojejunal tube feeding versus nil-by-mouth in acute pancreatitis: A randomized clinical trial. Pancreatology. 2016 Jul-Aug;16(4):523-8. doi: 10.1016/j.pan.2016.04.003. Epub 2016 Apr 13.

Reference Type: DERIVED

PMID: 27107634 (View on PubMed)

Other Identifiers

062-0000000-0211

Identifier Type: -

Identifier Source: org_study_id