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

Nanjing PLA General Hospital

Status and phase: Completed; Phase 3

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

Treatments: Dietary Supplement: enteral nutrition

Study type: Interventional

Funder types: Other

Identifiers

NCT01834430

2009NLY059

Details and patient eligibility

About

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.

Enrollment: 45 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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45 participants in 2 patient groups

EN group

Experimental group

Description:

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.

Treatment:

Dietary Supplement: enteral nutrition

parenteral nutrient group

No Intervention group