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Pectin Start Early Enteral Nutritional Support in Critically Ill Patients

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ClinicalTrials.gov Identifier: NCT02379624
Recruitment Status : Completed
First Posted : March 5, 2015
Last Update Posted : March 5, 2015
Sponsor:
Information provided by (Responsible Party):
Xingwei Xu, Nanjing University

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.


Condition or disease Intervention/treatment Phase
Nutrition Disorders Critical Illness Drug: pectin Phase 1 Phase 2

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 125 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pectin Start Early Enteral Nutritional Support in Critically Ill Patients
Study Start Date : August 2014
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Pectin

Arm Intervention/treatment
Placebo Comparator: EN group
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
Experimental: PEC/EN group
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
Drug: pectin
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 Measures :
  1. all-cause mortality [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. duration of organ support [ Time Frame: 30 days ]
  2. Efficacy as measured by frequency of treated infectious and noninfectious complications [ Time Frame: 30 days ]
  3. Efficacy as measured by frequency of Vomiting [ Time Frame: 30 days ]
  4. Efficacy as measured by frequency of Diarrhea [ Time Frame: 30 days ]
  5. Efficacy as measured by frequency of Abdominal distention or Cramping [ Time Frame: 30 days ]
  6. Efficacy as measured by frequency of Constipation [ Time Frame: 30 days ]
  7. Efficacy as measured by frequency of Regurgitation [ Time Frame: 30 days ]
  8. Efficacy as measured by frequency of Given antidiarrheal [ Time Frame: 30 days ]
  9. Efficacy as measured by frequency of Given prokinetic agents [ Time Frame: 30 days ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Responsible Party: Xingwei Xu, Doctor, Nanjing University
ClinicalTrials.gov Identifier: NCT02379624     History of Changes
Other Study ID Numbers: NNSF81270884
First Posted: March 5, 2015    Key Record Dates
Last Update Posted: March 5, 2015
Last Verified: February 2015

Additional relevant MeSH terms:
Critical Illness
Nutrition Disorders
Disease Attributes
Pathologic Processes
Pectin
Antidiarrheals
Gastrointestinal Agents