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

Not Applicable

Completed

Conditions: Nutrition, Enteral

Interventions: Dietary Supplement: semi-solid agent with standard enteral feeding
Other: standard enteral feeding

Registration Number: NCT03017079

Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

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).

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 40

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).

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
semi-solidification with nutrient	semi-solid agent with standard enteral feeding	semi-solidification with nutrient:after infusion of semi-solid agent, enteral nutrition is applied less than 60 mins. Intervention: Other: bolus Intermittent enteral feeding
Standard enteral nutrition	standard enteral feeding	After infusion of Sterile Water for Injection,bolus Intermittent enteral feeding via the nasogastric tube is applied less than 60 mins. Intervention: Other: Standard enteral feeding

Primary Outcome Measures

Name	Time	Method
the Ratio of the Enteral Nutrition	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 Outcome Measures

Name	Time	Method
the Glycemic Variability(GV)	3 days	Divided into three grades:I:GV less than 4mmol/24h; II 4-6mmol/24h;III more than 6mmol/24h
Length of Hospital Stay (LOS)	30 days	every participators stayed in hospital
the Patient of Feeding Intolerance（FI）	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.
the Patients With Lung Infection	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
30-days Mortality	30 days	dead within 30 days in ICU