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

Study Overview
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Brief Summary
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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.

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

Conditions
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Severe Acute Pancreatitis Patients, Duodenal Fistula, Inflammatory Intestinal Obstruction

Intervention / Treatment
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* Dietary Supplement: enteral nutrition


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EN group<br>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. | Dietary Supplement: enteral nutrition<br> <br> |
| No Intervention: parenteral nutrient group<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| all cause mortality |  | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| organ failure |  | 7 days |