Effects of Delayed Enteral Nutrition on Inflammatory Responses and Immune Function Competence in Critically Ill Patients With Prolonged Fasting

Phase 3

Completed

• Conditions: Severe Acute Pancreatitis Patients; Duodenal Fistula; Inflammatory Intestinal Obstruction

• Registration Number: NCT01834430
• Lead Sponsor: Nanjing PLA General Hospital

Brief Summary

Different studies suggest that early enteral nutrition (EEN) has benefits in reducing infectious complications, there is no data that addresses whether delayed enteral nutrition (EN) is detrimental and if it may have effects on inflammatory responses and immune function.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02
• Primary Completion: 2012-02
• Status Verified: 2013-04
• Study First Submitted: 2013-04-07
• Study First Submitted QC: 2013-04-15
• Last Update Submitted: 2013-04-15
• Study First Posted: 2013-04-17
• Last Update Posted: 2013-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• having a fasting time of more than 14 days
• American Society of Anesthesiologists (ASA) physical status ranging between 1 and 3, and their condition allows enteral nutrition therapy.

Exclusion Criteria

• chronic renal failure (peritoneal or hemodialysis or creatinine > 2.5 mg/dl)
• history of chronic obstructive pulmonary disease
• hepatic dysfunction or cirrhosis or a bilirubin value > 3 mg/dl
• metabolic diseases,severe anemia
• blood coagulation dysfunction
• pregnancy lactation
• history of psychiatric illness
• patients underwent immunosuppressive therapy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
all cause mortality	28 days

Secondary Outcome Measures

Name	Time	Method
organ failure	7 days