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
About this trial
This is an interventional treatment trial for Nutrition Disorders
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.
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
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
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