Clinical trial NCT03017079: A More Physiological Feeding Process in ICU:the Intermittent Infusion With Semi-solidification of Nutrients
Official title: A More Physiological Feeding Process in ICU:the Intermittent Infusion With Semi-solidification of Nutrients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nutrition, Enteral
Keywords: Semi-solidification
caloric debt
enteral nutrition
critical illness
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2017-01-11
Enrollment: 40
Sex: ALL
Minimum age (years): 14
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

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:

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

Primary outcomes:
measure: the Ratio of the Enteral Nutrition
timeFrame: 3 days after receiving enteral nutrition
Secondary outcomes:
measure: the Patient of Feeding Intolerance（FI）
timeFrame: 3 days
measure: the Patients With Lung Infection
timeFrame: 7 days
measure: 30-days Mortality
timeFrame: 30 days
measure: the Glycemic Variability(GV)
timeFrame: 3 days
measure: Length of Hospital Stay (LOS)
timeFrame: 30 days
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Second affiliated hospital, Zhejiang university school of medicine
state: Zhejiang
Study officials:
affiliation: Second affiliated hospital, Zhejiang university school of medicine
name: man huang, phD
role: PRINCIPAL_INVESTIGATOR
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