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

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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
Sponsor:
Information provided by (Responsible Party):
Man Huang, Ph.D, 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).

Condition or disease Intervention/treatment Phase
Nutrition, Enteral Dietary Supplement: semi-solid agent Other: standard enteral feeding Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
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

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. the percent prescribed calories received [ Time Frame: 3 days ]
    the EN calories received/the prescribed EN calories


Secondary Outcome Measures :
  1. the feeding intolerance [ Time Frame: 3 days ]
    contain one of the conditions:diarrhea, vomiting, regurgitation, obvious bowel distension and GRV>200mL.

  2. lung infection [ Time Frame: 7 days ]
  3. 30-days mortality [ Time Frame: 30 days ]
  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 ]


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Ages Eligible for Study:   14 Years to 90 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03017079


Contacts
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Contact: man huang, phD huangman@zju.edu.cn
Contact: Kongmiao Lu, Master 018268061252 lukongmiao123@163.com

Locations
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China, Zhejiang
Second affiliated hospital, Zhejiang university school of medicine Recruiting
Hangzhou, Zhejiang, China, 310052
Contact: Man Huang, Ph.D         
Contact: Kongmiao Lu, Master    018268061252    lukongmiao123@163.com   
Principal Investigator: Man Huang, Ph.D         
Sponsors and Collaborators
Second Affiliated Hospital, School of Medicine, Zhejiang University
Investigators
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Principal Investigator: man huang, phD Second affiliated hospital, Zhejiang university school of medicine
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Man Huang, Ph.D, Clinical Professor, Second Affiliated Hospital, School of Medicine, Zhejiang University
ClinicalTrials.gov Identifier: NCT03017079    
Other Study ID Numbers: lukongmiao123
First Posted: January 11, 2017    Key Record Dates
Last Update Posted: January 13, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Man Huang, Ph.D, Second Affiliated Hospital, School of Medicine, Zhejiang University:
Semi-solidification
caloric debt
enteral nutrition
critical illness
Additional relevant MeSH terms:
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Nutrients
Growth Substances
Physiological Effects of Drugs