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

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.

Study Overview

• Status: Completed
• Conditions: Severe Acute Pancreatitis Patients; Duodenal Fistula; Inflammatory Intestinal Obstruction
• Intervention / Treatment: Dietary supplement: enteral nutrition

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EN group; 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
No Intervention: parenteral nutrient group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
all cause mortality	28 days

Secondary Outcome Measures

Outcome Measure	Time Frame
organ failure	7 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
inflammatory markers	white blood cell count, C reactive protein(CRP), pro-inflammatory cytokines (TNF-a,IL-1,IL-6), and anti-inflammatory cytokines (IL-4, IL-10)	7 days

Collaborators and Investigators

• Sponsor: Nanjing PLA General Hospital

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (Actual): February 1, 2012

Study Registration Dates

• First Submitted: April 7, 2013
• First Submitted That Met QC Criteria: April 15, 2013
• First Posted (Estimate): April 17, 2013

Study Record Updates

• Last Update Posted (Estimate): April 17, 2013
• Last Update Submitted That Met QC Criteria: April 15, 2013
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Pathological Conditions, Anatomical; Pancreatic Diseases; Fistula; Pancreatitis; Intestinal Obstruction
• Other Study ID Numbers: 2009NLY059