A More Physiological Feeding Process in ICU:the Intermittent Infusion With Semi-solidification of Nutrients
|ClinicalTrials.gov Identifier: NCT03017079|
Recruitment Status : Unknown
Verified January 2017 by Man Huang, Ph.D, Second Affiliated Hospital, School of Medicine, Zhejiang University.
Recruitment status was: Recruiting
First Posted : January 11, 2017
Last Update Posted : January 13, 2017
|Condition or disease||Intervention/treatment||Phase|
|Nutrition, Enteral||Dietary Supplement: semi-solid agent Other: standard enteral feeding||Not Applicable|
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).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A More Physiological Feeding Process in ICU:the Intermittent Infusion With Semi-solidification of Nutrients|
|Study Start Date :||December 2016|
|Estimated Primary Completion Date :||March 2017|
|Estimated Study Completion Date :||March 2017|
Experimental: semi-solidification with nutrient
semi-solidification with nutrient:after infusion of semi-solid agent, enteral nutrition is applied less than 60 mins.
Intervention: Other: bolus Intermittent enteral feeding
Dietary Supplement: semi-solid agent
after infusion of semi-solid agent, Intermittent enteral feeding is applied less than 60 mins
Other Name: semi-solidification of nutrient
Placebo Comparator: Standard enteral nutrition
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
Other: standard enteral feeding
Intermittent enteral feeding is applied less than 60 mins
Other Name: standard enteral nutrition
- the percent prescribed calories received [ Time Frame: 3 days ]the EN calories received/the prescribed EN calories
- the feeding intolerance [ Time Frame: 3 days ]contain one of the conditions:diarrhea, vomiting, regurgitation, obvious bowel distension and GRV>200mL.
- lung infection [ Time Frame: 7 days ]
- 30-days mortality [ Time Frame: 30 days ]
- 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
- Length of hospital stay (LOS) [ Time Frame: 30 days ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03017079
|Contact: man huang, phDemail@example.com|
|Contact: Kongmiao Lu, Masterfirstname.lastname@example.org|
|Second affiliated hospital, Zhejiang university school of medicine||Recruiting|
|Hangzhou, Zhejiang, China, 310052|
|Contact: Man Huang, Ph.D|
|Contact: Kongmiao Lu, Master 018268061252 email@example.com|
|Principal Investigator: Man Huang, Ph.D|
|Principal Investigator:||man huang, phD||Second affiliated hospital, Zhejiang university school of medicine|