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

Primary Purpose

Severe Acute Pancreatitis Patients, Duodenal Fistula, Inflammatory Intestinal Obstruction

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
enteral nutrition
Sponsored by
Nanjing PLA General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Severe Acute Pancreatitis Patients

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    EN group

    parenteral nutrient group

    Arm 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.

    Outcomes

    Primary Outcome Measures

    all cause mortality

    Secondary Outcome Measures

    organ failure

    Full Information

    First Posted
    April 7, 2013
    Last Updated
    April 15, 2013
    Sponsor
    Nanjing PLA General Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01834430
    Brief Title
    Effects of Delayed Enteral Nutrition on Inflammatory Responses and Immune Function Competence in Critically Ill Patients With Prolonged Fasting
    Official Title
    Effects of Delayed Enteral Nutrition on Inflammatory Responses and Immune Function Competence in Critically Ill Patients With Prolonged Fasting
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2010 (undefined)
    Primary Completion Date
    February 2012 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Nanjing PLA General Hospital

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Severe Acute Pancreatitis Patients, Duodenal Fistula, Inflammatory Intestinal Obstruction

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    45 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    EN group
    Arm Type
    Experimental
    Arm 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.
    Arm Title
    parenteral nutrient group
    Arm Type
    No Intervention
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    enteral nutrition
    Primary Outcome Measure Information:
    Title
    all cause mortality
    Time Frame
    28 days
    Secondary Outcome Measure Information:
    Title
    organ failure
    Time Frame
    7 days
    Other Pre-specified Outcome Measures:
    Title
    inflammatory markers
    Description
    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)
    Time Frame
    7 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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

    12. IPD Sharing Statement

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