Pectin Start Early Enteral Nutritional Support in Critically Ill Patients

NCT02379624 | Completed Phase 1 DMC

• 1 other identifier: NNSF81270884
• Study Type: interventional
• Target: 125
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Nutrition Disorders; Critical Illness

Outcome Measures

Primary Outcomes (1)

• all-cause mortality

  30 days

Secondary Outcomes (9)

• duration of organ support

  30 days

• Efficacy as measured by frequency of treated infectious and noninfectious complications

  30 days

• Efficacy as measured by frequency of Vomiting

  30 days

• Efficacy as measured by frequency of Diarrhea

  30 days

• Efficacy as measured by frequency of Abdominal distention or Cramping

  30 days

Study Arms (2)

EN group

PLACEBO COMPARATOR

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

PEC/EN group

EXPERIMENTAL

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

Interventions

pectin DRUG

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.

PEC/EN group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xingwei Xu: lead

MeSH Terms

Conditions

Nutrition Disorders; Critical Illness

Interventions

Pectins

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates; Plant Extracts; Plant Preparations; Biological Products; Complex Mixtures

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: August 30, 2014
• First Posted: March 5, 2015
• Study Start: August 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: March 5, 2015

Record last verified: 2015-02