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

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ClinicalTrials.gov Identifier: NCT01834430
Recruitment Status : Completed
First Posted : April 17, 2013
Last Update Posted : April 17, 2013
Sponsor:
Information provided by (Responsible Party):
Gao Tao, Nanjing PLA General Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Severe Acute Pancreatitis Patients Duodenal Fistula Inflammatory Intestinal Obstruction Dietary Supplement: enteral nutrition Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Delayed Enteral Nutrition on Inflammatory Responses and Immune Function Competence in Critically Ill Patients With Prolonged Fasting
Study Start Date : February 2010
Actual Primary Completion Date : February 2012

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Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. all cause mortality [ Time Frame: 28 days ]

Secondary Outcome Measures :
  1. organ failure [ Time Frame: 7 days ]

Other Outcome Measures:
  1. inflammatory markers [ Time Frame: 7 days ]
    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)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Responsible Party: Gao Tao, Clinical Professor, Nanjing PLA General Hospital
ClinicalTrials.gov Identifier: NCT01834430    
Other Study ID Numbers: 2009NLY059
First Posted: April 17, 2013    Key Record Dates
Last Update Posted: April 17, 2013
Last Verified: April 2013
Additional relevant MeSH terms:
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Pancreatitis
Intestinal Obstruction
Fistula
Pathological Conditions, Anatomical
 Pancreatic Diseases
Digestive System Diseases
Intestinal Diseases
Gastrointestinal Diseases