An interventional study of semi-solid agent with standard enteral feeding and standard enteral feeding in Nutrition, Enteral, sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. Completed at 1 site in China. Open to participants aged 14 Years to 90 Years. Per ClinicalTrials.gov, last updated 2021-11-02.
Sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University · Not applicable, Interventional, and Prevention
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).
Second Affiliated Hospital, School of Medicine, Zhejiang University is the lead sponsor of 1,058 studies on the registry; 511 are open to participants now.
Counted across the registry records on this site, refreshed daily.
(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:
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
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
after infusion of semi-solid agent, Intermittent enteral feeding is applied less than 60 minutes
Also known as: semi-solidification of nutrient
Intermittent enteral feeding is applied less than 60 minutes
Also known as: standard enteral nutrition
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
Time frame: 3 days after receiving enteral nutrition
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.
Time frame: 3 days
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
Time frame: 7 days
30-days Mortality
dead within 30 days in ICU
Time frame: 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
Time frame: 3 days
Length of Hospital Stay (LOS)
every participators stayed in hospital
Time frame: 30 days
| Milestone | Semi-solidification With Nutrient | Standard Enteral Nutrition |
|---|---|---|
| Started | 20 | 20 |
| Completed | 14 | 14 |
| Not completed | 6 | 6 |
| Withdrew: Physician decision | 1 | 1 |
| Withdrew: Death | 3 | 2 |
| Withdrew: Lack of efficacy | 2 | 2 |
| Withdrew: Protocol violation | 0 | 1 |
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
| ratio | Intermittent Feeding With Semi-solid Nutrients | Standard Enteral Feeding |
|---|---|---|
| the Ratio of the Enteral Nutrition | 0.98 ± 0.067 | 0.73 ± 0.15 |
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.
| participants | Intermittent Feeding | Intermittent Feeding With Semi-solid Nutrients |
|---|---|---|
| the Patient of Feeding Intolerance（FI） | 8 | 2 |
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
| participants | Intermittent Feeding | Intermittent Feeding With Semi-solid Nutrients |
|---|---|---|
| the Patients With Lung Infection | 8 | 7 |
dead within 30 days in ICU
| participants | Intermittent Feeding With Semi-solid Nutrients | Intermittent Feeding |
|---|---|---|
| The number of deaths within 30 days after ICU | 3 | 2 |
| The number of live after 30 days in ICU | 11 | 12 |
Divided into three grades:I:GV less than 4mmol/24h; II 4-6mmol/24h;III more than 6mmol/24h
| mmol/l | Intermittent Feeding With Semi-solid Nutrients | Intermittent Feeding |
|---|---|---|
| 1d-0h | 7.514 ± 2.2309 | 8.457 ± 2.9456 |
| 1d-4h | 8.336 ± 2.1653 | 9.700 ± 3.1001 |
| 1d-8h | 9.229 ± 3.2587 | 9.664 ± 3.1023 |
| 1d-12h | 9.342857 ± 3.1353357 | 8.985714 ± 3.2846630 |
| 1d-16h | 8.635714 ± 2.4069154 | 8.992857 ± 3.1086639 |
| 1d-20h | 8.064286 ± 1.9727400 | 8.721429 ± 2.5137097 |
| 2d-0h | 8.436 ± 2.2016 | 8.686 ± 2.9493 |
| 2d-4h | 8.857 ± 2.5687 | 9.450 ± 3.1889 |
| 2d-8h | 10.471 ± 3.0698 | 9.064 ± 2.8527 |
| 2d-12h | 9.543 ± 3.5213 | 9.514 ± 3.6367 |
| 2d-16h | 9.343 ± 3.4469 | 8.821 ± 3.6413 |
| 2d-20h | 8.807 ± 3.4130 | 7.807 ± 2.8073 |
| 3d-0h | 8.135714 ± 2.5548166 | 8.250000 ± 4.3164711 |
| 3d-4h | 8.579 ± 2.8282 | 9.486 ± 3.7223 |
| 3d-8h | 9.121 ± 2.8011 | 8.879 ± 3.0238 |
| 3d-12h | 8.721 ± 2.8072 | 9.429 ± 3.0648 |
| 3d-16h | 9.328571 ± 3.2257208 | 8.935714 ± 2.2210902 |
| 3d-20h | 8.250000 ± 2.3299884 | 7.957143 ± 2.0129253 |
every participators stayed in hospital
| days | Intermittent Feeding With Semi-solid Nutrients | Intermittent Feeding |
|---|---|---|
| Length of Hospital Stay (LOS) | 20.07 ± 25.71 | 14.36 ± 7.59 |
Collected over Total follow-up 1 month. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Standard Enteral Nutrition | 2/14 (14.3%) | 0/14 (0%) | 0/14 (0%) |
| Semi-solidification With Nutrient | 3/14 (21.4%) | 0/14 (0%) | 0/14 (0%) |
| Age, Continuous(years) | Semi-solidification With Nutrient | Standard Enteral Nutrition | Total |
|---|---|---|---|
| Mean | 54.93 ± 20.96 | 52.14 ± 13.77 | 53.54 ± 17.45 |
| Sex: Female, Male(Participants) | Semi-solidification With Nutrient | Standard Enteral Nutrition | Total |
|---|---|---|---|
| Female | 5 | 5 | 10 |
| Male | 9 | 9 | 18 |
| Ethnicity (NIH/OMB)(Participants) | Semi-solidification With Nutrient | Standard Enteral Nutrition | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 0 | 0 | 0 |
| Unknown or Not Reported | 14 | 14 | 28 |
| Race (NIH/OMB)(Participants) | Semi-solidification With Nutrient | Standard Enteral Nutrition | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 14 | 14 | 28 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Semi-solidification With Nutrient | Standard Enteral Nutrition | Total |
|---|---|---|---|
| China | 14 | 14 | 28 |
| NRS 2002(units on a scale) | Semi-solidification With Nutrient | Standard Enteral Nutrition | Total |
|---|---|---|---|
| Mean | 3.14 ± 0.77 | 2.86 ± 0.95 | 3 ± 0.86 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Second Affiliated Hospital, School of Medicine, Zhejiang University