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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).
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| semi-solid agent with standard enteral feeding | Dietary Supplement | after infusion of semi-solid agent, Intermittent enteral feeding is applied less than 60 minutes |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| the Patient of Feeding Intolerance(FI) | 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. | 3 days |
| the Patients With Lung Infection |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| man huang, phD | Second affiliated hospital, Zhejiang university school of medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Second affiliated hospital, Zhejiang university school of medicine | Hangzhou | Zhejiang | 310052 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24714361 | Background | 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. | |
| 27051616 |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 semi-solid agent: after infusion of semi-solid agent, Intermittent enteral feeding is applied less than 60 mins |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 24, 2016 | Sep 10, 2018 |
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| standard enteral feeding | Other | Intermittent enteral feeding is applied less than 60 minutes |
|
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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 |
| 7 days |
| 30-days Mortality | dead within 30 days in ICU | 30 days |
| the Glycemic Variability(GV) | Divided into three grades:I:GV less than 4mmol/24h; II 4-6mmol/24h;III more than 6mmol/24h | 3 days |
| Length of Hospital Stay (LOS) | every participators stayed in hospital | 30 days |
| 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. |
| 17622869 | 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. |
| 26771786 | 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. |
| 18230864 | 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). |
| 22242022 | 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. |
| 24812000 | 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. |
| 30200118 | Derived | 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. |
| 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 standard enteral feeding: Intermittent enteral feeding is applied less than 60 mins |
| COMPLETED | Death:defined as death within 3 days of enrollment |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 semi-solid agent: after infusion of semi-solid agent, Intermittent enteral feeding is applied less than 60 mins |
| BG001 | 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 standard enteral feeding: Intermittent enteral feeding is applied less than 60 mins |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants | No |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
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| NRS 2002 | NRS 2002 range from 0 to 7,and The higher the score, the higher the nutritional risk | Mean | Standard Deviation | units on a scale |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Mean | Standard Deviation | ratio | 3 days after receiving enteral nutrition |
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| Secondary | the Patient of Feeding Intolerance(FI) | 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. | Posted | Number | participants | 3 days |
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| Secondary | the Patients With Lung Infection | 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 | Posted | Number | participants | 7 days |
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| Secondary | 30-days Mortality | dead within 30 days in ICU | Posted | Number | participants | 30 days |
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| Secondary | the Glycemic Variability(GV) | Divided into three grades:I:GV less than 4mmol/24h; II 4-6mmol/24h;III more than 6mmol/24h | Posted | Mean | Standard Deviation | mmol/l | 3 days |
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| Secondary | Length of Hospital Stay (LOS) | every participators stayed in hospital | Posted | Mean | Standard Deviation | days | 30 days |
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Total follow-up 1 month
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard Enteral Nutrition | We only record the daily enteral nutrition prescribed and received as well as the acute complications of enteral nutrition (EN) such as diarrhea, vomiting, regurgitation, bowel distension and lung infection in this study, no other adverse was found | 2 | 14 | 0 | 14 | 0 | 14 |
| EG001 | Semi-solidification With Nutrient | We only record the daily enteral nutrition prescribed and received as well as the acute complications of enteral nutrition (EN) such as diarrhea, vomiting, regurgitation, bowel distension and lung infection in this study, no other adverse was found | 3 | 14 | 0 | 14 | 0 | 14 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr | THE SECOND AFFILIATED HOSPITAL ZHEJIANG UNIVERSITY SCHOOL OF MEDICINE | 18817821529 | hm198699@126.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 24, 2016 | Sep 10, 2018 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 24, 2016 | Sep 10, 2018 | ICF_002.pdf |
| ID | Term |
|---|---|
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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