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

NCT03017079 | Completed Results DMC

• 1 other identifier: lukongmiao123
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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).

Conditions

Nutrition, Enteral

Keywords

Semi-solidification; caloric debt; enteral nutrition; critical illness

Outcome Measures

Primary Outcomes (1)

• the Ratio of the 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

  3 days after receiving enteral nutrition

Secondary Outcomes (5)

• the Patient of Feeding Intolerance（FI）

  3 days

• the Patients With Lung Infection

  7 days

• 30-days Mortality

  30 days

• the Glycemic Variability(GV)

  3 days

• Length of Hospital Stay (LOS)

  30 days

Study Arms (2)

semi-solidification with nutrient

EXPERIMENTAL

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 with standard enteral feeding

Standard enteral nutrition

PLACEBO COMPARATOR

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

Interventions

semi-solid agent with standard enteral feeding DIETARY_SUPPLEMENT

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

Also known as: semi-solidification of nutrient

semi-solidification with nutrient

standard enteral feeding OTHER

Intermittent enteral feeding is applied less than 60 minutes

Also known as: standard enteral nutrition

Standard enteral nutrition

Eligibility Criteria

• Age: 14 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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).

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

Second affiliated hospital, Zhejiang university school of medicine

Hangzhou, Zhejiang, 310052, China

Location

Related Publications (8)

• Peev MP, Yeh DD, Quraishi SA, Osler P, Chang Y, Gillis E, Albano CE, Darak S, Velmahos GC. Causes and consequences of interrupted enteral nutrition: a prospective observational study in critically ill surgical patients. JPEN J Parenter Enteral Nutr. 2015 Jan;39(1):21-7. doi: 10.1177/0148607114526887. Epub 2014 Apr 7.

  PMID: 24714361 BACKGROUND

• Evans DC, Forbes R, Jones C, Cotterman R, Njoku C, Thongrong C, Tulman D, Bergese SD, Thomas S, Papadimos TJ, Stawicki SP. Continuous versus bolus tube feeds: Does the modality affect glycemic variability, tube feeding volume, caloric intake, or insulin utilization? Int J Crit Illn Inj Sci. 2016 Jan-Mar;6(1):9-15. doi: 10.4103/2229-5151.177357.

  PMID: 27051616 RESULT

• MacLeod JB, Lefton J, Houghton D, Roland C, Doherty J, Cohn SM, Barquist ES. Prospective randomized control trial of intermittent versus continuous gastric feeds for critically ill trauma patients. J Trauma. 2007 Jul;63(1):57-61. doi: 10.1097/01.ta.0000249294.58703.11.

  PMID: 17622869 RESULT

• Taylor BE, McClave SA, Martindale RG, Warren MM, Johnson DR, Braunschweig C, McCarthy MS, Davanos E, Rice TW, Cresci GA, Gervasio JM, Sacks GS, Roberts PR, Compher C; Society of Critical Care Medicine; American Society of Parenteral and Enteral Nutrition. Guidelines for the Provision and Assessment of Nutrition Support Therapy in the Adult Critically Ill Patient: Society of Critical Care Medicine (SCCM) and American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.). Crit Care Med. 2016 Feb;44(2):390-438. doi: 10.1097/CCM.0000000000001525. No abstract available.

  PMID: 26771786 RESULT

• Logemann JA, Gensler G, Robbins J, Lindblad AS, Brandt D, Hind JA, Kosek S, Dikeman K, Kazandjian M, Gramigna GD, Lundy D, McGarvey-Toler S, Miller Gardner PJ. A randomized study of three interventions for aspiration of thin liquids in patients with dementia or Parkinson's disease. J Speech Lang Hear Res. 2008 Feb;51(1):173-83. doi: 10.1044/1092-4388(2008/013).

  PMID: 18230864 RESULT

• Bardhan KD, Strugala V, Dettmar PW. Reflux revisited: advancing the role of pepsin. Int J Otolaryngol. 2012;2012:646901. doi: 10.1155/2012/646901. Epub 2011 Nov 10.

  PMID: 22242022 RESULT

• Hayat JO, Gabieta-Somnez S, Yazaki E, Kang JY, Woodcock A, Dettmar P, Mabary J, Knowles CH, Sifrim D. Pepsin in saliva for the diagnosis of gastro-oesophageal reflux disease. Gut. 2015 Mar;64(3):373-80. doi: 10.1136/gutjnl-2014-307049. Epub 2014 May 7.

  PMID: 24812000 RESULT

• Lu K, Zeng F, Li Y, Chen C, Huang M. A more physiological feeding process in ICU: Intermittent infusion with semi-solid nutrients (CONSORT-compliant). Medicine (Baltimore). 2018 Sep;97(36):e12173. doi: 10.1097/MD.0000000000012173.

  PMID: 30200118 DERIVED

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr
• Organization: THE SECOND AFFILIATED HOSPITAL ZHEJIANG UNIVERSITY SCHOOL OF MEDICINE

hm198699@126.com

18817821529

Study Officials

• man huang, phD

  Second affiliated hospital, Zhejiang university school of medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: January 6, 2017
• First Posted: January 11, 2017
• Study Start: June 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: November 2, 2021
• Results First Posted: November 2, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)