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NCT Number: NCT03017079

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

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).

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Key information

Conditions

Nutrition, Enteral Critical Illness Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

14 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Second affiliated hospital, Zhejiang university school of medicine

Hangzhou, Zhejiang, 310052, China

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

semi-solid agent with standard enteral feeding

Dietary Supplement

after infusion of semi-solid agent, Intermittent enteral feeding is applied less than 60 minutes

Other names: semi-solidification of nutrient

standard enteral feeding

Other

Intermittent enteral feeding is applied less than 60 minutes

Other names: standard enteral nutrition

Primary outcomes

  1. 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

  1. the Patient of Feeding Intolerance（FI）

    Time frame: 3 days

    the definition of FI was included one of the conditions:diarrhea, vomiting, regurgitation, obvious bowel distension and GRV>200mL.

    Due to the small sample size, only the number of patients who occurred was recorded.

  2. the Patients With Lung Infection

    Time frame: 7 days

    patient contain the following three conditions:

    1.Sputum volume increased or Sputum properties change;2.CT Scan-Chest suggest that there was lung infection; 3.CRP and / or PCT increased

  3. 30-days Mortality

    Time frame: 30 days

    dead within 30 days in ICU

  4. the Glycemic Variability(GV)

    Time frame: 3 days

    Divided into three grades:I:GV less than 4mmol/24h; II 4-6mmol/24h;III more than 6mmol/24h

  5. Length of Hospital Stay (LOS)

    Time frame: 30 days

    every participators stayed in hospital

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jan 11, 2017
Registry last updated
Nov 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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