Early Enteral Nutrition for Severe Acute Pancreatitis

Sichuan Academy of Medical Sciences

Status and phase: Completed; Phase 4

Conditions: Acute Necrotizing Pancreatitis

Treatments: Dietary Supplement: early enteral nutrition; Dietary Supplement: Parenteral nutrition

Study type: Interventional

Funder types: Other

Identifiers

NCT00995098

SAMS-080384

Details and patient eligibility

About

There is increasing evidence that indicates early enteral nutrition may be associated with improved outcome in acute pancreatitis patients. However, most of the clinical trials regarding this targeted mild to moderated pancreatitis patients. In regard to severe acute pancreatitis (SAP) patients, current results from randomized control trials (RCTs) are inconclusive. The researchers of this study aim to investigate the impact of early enteral nutrition on the clinical outcomes of SAP patients.

Enrollment: 42 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of severe acute pancreatitis
• Consent informed

Exclusion criteria

• Diabetes mellitus
• Allergy for any ingredient of PN or EN regimen
• Pregnancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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42 participants in 2 patient groups

Early enteral nutrition

Experimental group

Description:

Twenty patient will be enrolled into this arm. Enteral nutrition administration will start within 24 hours after admission through naso-jejunal tube and continue for 7 days after admission.Naso-jejunal tube will be set up by endoscopy.

Treatment:

Dietary Supplement: early enteral nutrition

Control: Parenteral Nutrition

Active Comparator group

Description:

Twenty patient will be enrolled into this arm. PN administration will start within 24 hours after admission and continue for 7 days after admission.Parenteral nutrition will be administered through subclavian central venous catheter.

Treatment:

Dietary Supplement: Parenteral nutrition