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
• Interventions: Dietary Supplement: enteral nutrition

• 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

Arm && Interventions

Group	Intervention	Description
EN group	enteral nutrition	The EN group gradually restored enteral nutrition, while the PN group continued to receive parenteral nutrition treatment. Both groups received between 20 to 25 kcal/kg/day and 1.5 g/kg/day of protein. Because of the low volume, concentration, and calorie amount, on the first day, tube feeding utilized 500 ml with the speed of 30 \~ 50 ml/h. On the second day, tube feeding utilized 1000 ml with the speed of 60 \~ 80 ml/h. On the third day, tube feeding utilized 1500 \~ 2000 ml with the speed of 100 \~ 120 ml/h. If enteral nutrition could not meet a patient's caloric requirements, PN supplement was started on the fourth day. The required calories and protein for each individual in the two groups was assumed to be achieved after three days of therapy. The PN group continued to receive parenteral nutrition.

Primary Outcome Measures

Name	Time	Method
all cause mortality	28 days

Secondary Outcome Measures

Name	Time	Method
organ failure	7 days