search
Back to results

Pectin Start Early Enteral Nutritional Support in Critically Ill Patients

Primary Purpose

Nutrition Disorders, Critical Illness

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
pectin
Sponsored by
Xingwei Xu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nutrition Disorders

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria::

  • Adult ICU patients who were at least 18 years old if they were expected to require EN support within 36 hours after an unplanned ICU admission.

Exclusion Criteria:

  • Could not be fed through enteral route,
  • Had received EN in the past 2 months,
  • Had a colectomy or jejunostomy in situ,
  • Had severe colonic disease such as ulcerative colitis and Crohn's,
  • Had pregnant,
  • Had EN taboo crowd.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Experimental

    Arm Label

    EN group

    PEC/EN group

    Arm Description

    5% glucose at a rate of 25 mL/h was given at day 1, followed with initial amount of EN (31.25g peptisorb dissolved in 250ml water) at 12.5 mL/h on day 2. From day 3 to day 6, the prescription is EN (62.5g peptisorb dissolved in 250ml water) at 12.5 mL/h. Since day 7, EN was began to advance to goal energy target as quickly as possibl

    An additional amount of pectin was added 4 hours ahead of EN given from day 2 to day 6 (24g everday). Since day 7, EN was advanced to goal energy target as the same step

    Outcomes

    Primary Outcome Measures

    all-cause mortality

    Secondary Outcome Measures

    duration of organ support
    Efficacy as measured by frequency of treated infectious and noninfectious complications
    Efficacy as measured by frequency of Vomiting
    Efficacy as measured by frequency of Diarrhea
    Efficacy as measured by frequency of Abdominal distention or Cramping
    Efficacy as measured by frequency of Constipation
    Efficacy as measured by frequency of Regurgitation
    Efficacy as measured by frequency of Given antidiarrheal
    Efficacy as measured by frequency of Given prokinetic agents

    Full Information

    First Posted
    August 30, 2014
    Last Updated
    March 4, 2015
    Sponsor
    Xingwei Xu
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02379624
    Brief Title
    Pectin Start Early Enteral Nutritional Support in Critically Ill Patients
    Official Title
    Pectin Start Early Enteral Nutritional Support in Critically Ill Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2014 (undefined)
    Primary Completion Date
    January 2015 (Actual)
    Study Completion Date
    January 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Xingwei Xu

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Acute lower gastrointestinal dysfunction is a kind of much common complication which occurred in critically ill patients. Once it developed, enteral nutrition would be disturbed. In this study, investigators suppose that early application of a sufficient amount of pectin ahead of enteral nutrition, may promote recovery of acute lower gastrointestinal dysfunction in critically ill patients, and exert its good effect on early EN support. Investigators designed this prospective randomized controlled trial to test and evaluates the effect whether EN feeding with or without a pectin start would be safe or with advanced clinical outcomes.
    Detailed Description
    Gastrointestinal function (GI) is an important determinant in the outcome of critically ill patients, with up to 62% of patients exhibiting at least one GI symptom for at least 1 day. Unlike the upper gastrointestinal dysfunction, which can be diagnosed early because of abdominal distension, nausea, and feeding intolerance, acute lower gastrointestinal dysfunction (ALGID) is a kind of more common complication which more easily neglected due to atypical symptoms. Once ALGID developed, critical patients could not get enteral nutrition (EN) normally, as early EN support is often essential and standard on critically ill patients when feasible. It also causes colonic bacteria reflux to the ileum and jejunum, leads to ischemic necrosis or colon perforation, and increases the incidence of various adverse events. Dietary fiber (DF) plays an important and helpful role in GI. It undergoes partial or total fermentation in the distal small bowel and colon, leading to the production of short chain fatty acids (SCFA) and gas. It also helps to conduct slower and delayed gastroenterology absorption, and reduce luminal flow. To date, many research and evidences exist for DF-supplemented EN reduces the incidence of colonic dysfunction in non-intensive care unit studies. However, until recently, it still lacks guidelines on how to conduct DF-supplemented EN rationally in critically ill patients. Pectin, a representative DF, is a gelatinous substance derived from the cell walls of fruits and some plants and contains galacturonan, consisting of mostly long-chain D-galacturonic acids combined into units by α-1,4 linkages. As a kind of soluble dietary fiber, pectin has been proved of controlling glucose and blood lipids. It slows rapid infusion of the liquid meal into the gut by delaying gastric emptying. Studies showed that 90% of ingested pectin can be found in the terminal ileum. In view of all the former studies data and on the basis of investigators' clinical observation, investigators postulate that early application of a sufficient amount of pectin ahead of EN, may promote ALGID recovery in critically ill patients, and exert its effect. Investigators designed this prospective randomized controlled trial to test whether EN feeding with or without a pectin start would be safe or with advanced clinical outcomes. Investigators speculated that pectin start EN could nourish the digestive tract in critically ill patients, and it is superior to traditional EN feeding for the delivery of early nutritional support.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Nutrition Disorders, Critical Illness

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    125 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    EN group
    Arm Type
    Placebo Comparator
    Arm Description
    5% glucose at a rate of 25 mL/h was given at day 1, followed with initial amount of EN (31.25g peptisorb dissolved in 250ml water) at 12.5 mL/h on day 2. From day 3 to day 6, the prescription is EN (62.5g peptisorb dissolved in 250ml water) at 12.5 mL/h. Since day 7, EN was began to advance to goal energy target as quickly as possibl
    Arm Title
    PEC/EN group
    Arm Type
    Experimental
    Arm Description
    An additional amount of pectin was added 4 hours ahead of EN given from day 2 to day 6 (24g everday). Since day 7, EN was advanced to goal energy target as the same step
    Intervention Type
    Drug
    Intervention Name(s)
    pectin
    Intervention Description
    Pectin, a representative diety fibre, is a gelatinous substance derived from the cell walls of fruits and some plants and contains galacturonan, consisting of mostly long-chain D-galacturonic acids combined into units by α-1,4 linkages. As a kind of soluble dietary fiber, pectin has been proved of controlling glucose and blood lipids. It slows rapid infusion of the liquid meal into the gut by delaying gastric emptying.
    Primary Outcome Measure Information:
    Title
    all-cause mortality
    Time Frame
    30 days
    Secondary Outcome Measure Information:
    Title
    duration of organ support
    Time Frame
    30 days
    Title
    Efficacy as measured by frequency of treated infectious and noninfectious complications
    Time Frame
    30 days
    Title
    Efficacy as measured by frequency of Vomiting
    Time Frame
    30 days
    Title
    Efficacy as measured by frequency of Diarrhea
    Time Frame
    30 days
    Title
    Efficacy as measured by frequency of Abdominal distention or Cramping
    Time Frame
    30 days
    Title
    Efficacy as measured by frequency of Constipation
    Time Frame
    30 days
    Title
    Efficacy as measured by frequency of Regurgitation
    Time Frame
    30 days
    Title
    Efficacy as measured by frequency of Given antidiarrheal
    Time Frame
    30 days
    Title
    Efficacy as measured by frequency of Given prokinetic agents
    Time Frame
    30 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria:: Adult ICU patients who were at least 18 years old if they were expected to require EN support within 36 hours after an unplanned ICU admission. Exclusion Criteria: Could not be fed through enteral route, Had received EN in the past 2 months, Had a colectomy or jejunostomy in situ, Had severe colonic disease such as ulcerative colitis and Crohn's, Had pregnant, Had EN taboo crowd.

    12. IPD Sharing Statement

    Learn more about this trial

    Pectin Start Early Enteral Nutritional Support in Critically Ill Patients

    We'll reach out to this number within 24 hrs