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Clinical Trials/NCT03017079
NCT03017079
Completed
Not Applicable

A More Physiological Feeding Process in ICU:the Intermittent Infusion With Semi-solidification of Nutrients

Second Affiliated Hospital, School of Medicine, Zhejiang University1 site in 1 country40 target enrollmentJune 1, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Nutrition, Enteral
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Enrollment
40
Locations
1
Primary Endpoint
the Ratio of the Enteral Nutrition
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

Malnutrition and underfeeding are major challenges in caring for critically ill patients. Continuous feeding were thought to be better tolerated by patients with the limited absorptive gut surface area or gastrointestinal dysfunction, but associated with more tube clogging and required the patient to be attached to an infusion pump for significant periods of time. Intermittent infusion resembled more physiological feeding process, which allowed greater patient mobility and might reach goal enteral calories earlier, and the latter were considered to effectively decrease the length of stay (LOS)-in-hospital and mortality. However, it also had some previous study found that intermittent infusion had more complications, such as diarrhea, regurgitation than continuous. Some study found that it was an efficient way to prevent aspiration and reflux by increasing the enteral nutrient solution viscosity and improve bolus intermittent feeding intolerance. The primary goal of this was to study whether receiving semi-solidification of nutrients could increase the percent prescribed calories received by improving the feeding intolerance, and secondary goal was to observing the effect of semi-solid nutrient to the LOS of ICU and in-hospital, lung infection, 30-days mortality and the glycemic variability (GV).

Detailed Description

Enteral nutrition (EN) therapy is an essential part in critically ill patients,and can be administered on a continuous or intermittent, but there were no consensus on which should be adopted. Continuous feeding were thought to be better tolerated by patients with the limited absorptive gut surface area or gastrointestinal dysfunction, but associated with more tube clogging and required the patient to be attached to an infusion pump for significant periods of time. Intermittent infusion resembled more physiological feeding process, which allowed greater patient mobility and might reach goal enteral calories earlier, and the latter were considered to effectively decrease the LOS-in-hospital and mortality. However, it also had some previous study found that intermittent infusion had more complications, such as diarrhea, regurgitation than continuous. Recently, some study found that it was an efficient way to prevent aspiration and reflux by increasing the enteral nutrient solution viscosity and improve bolus intermittent feeding intolerance. In dementia or Parkinson's patients, one study showed that high-viscosity liquid meal could decrease the incidence of aspiration, compared with the thin liquid, but the study about the viscosity of nutrition was little and the sample size was small. In this study, the primary goal of this was to study whether receiving semi-solidification of nutrients could increase the percent prescribed calories received by improving the feeding intolerance, and secondary goal was to observing the effect of semi-solid nutrient to the LOS of ICU and in-hospital, lung infection, 30-days mortality and the glycemic variability (GV).

Registry
clinicaltrials.gov
Start Date
June 1, 2016
End Date
March 1, 2017
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Responsible Party
Principal Investigator
Principal Investigator

Man Huang, Ph.D

Clinical Professor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Eligibility Criteria

Inclusion Criteria

  • (1)14 years and older, who received EN for more than 72 hours, were eligible for inclusion (2) all patients started on EN by nasogastric tube

Exclusion Criteria

  • received EN \<72 hours
  • received EN prior to ICU admission
  • had acute pulmonary infection
  • had history of Gastrointestinal surgery
  • had contraindications of EN, such as intestinal obstruction (mechanical or paralytic ileus).

Outcomes

Primary Outcomes

the Ratio of the Enteral Nutrition

Time Frame: 3 days after receiving enteral nutrition

the ratio of the enteral nutrition=administered volume of enteral nutrition / prescribed volume of nutrition X 100%; This ratio fluctuates between 0 and 100%, and the higher the ratio, the higher the execution rate

Secondary Outcomes

  • the Glycemic Variability(GV)(3 days)
  • Length of Hospital Stay (LOS)(30 days)
  • the Patient of Feeding Intolerance(FI)(3 days)
  • the Patients With Lung Infection(7 days)
  • 30-days Mortality(30 days)

Study Sites (1)

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