Nutrition, Enteral
Conditions
Keywords
Semi-solidification, caloric debt, enteral nutrition, critical illness
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).
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).
Interventions
DIETARY_SUPPLEMENTsemi-solid agent with standard enteral feeding
after infusion of semi-solid agent, Intermittent enteral feeding is applied less than 60 minutes
OTHERstandard enteral feeding
Intermittent enteral feeding is applied less than 60 minutes
Sponsors
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
14 Years to 90 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the Ratio of the Enteral Nutrition | 3 days after receiving 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| the Patient of Feeding Intolerance（FI） | 3 days | 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. |
| the Patients With Lung Infection | 7 days | 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 |
| 30-days Mortality | 30 days | dead within 30 days in ICU |
| the Glycemic Variability(GV) | 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) | 30 days | every participators stayed in hospital |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 14 |
| 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 | 14 |
| Total | 28 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 3 | 2 |
| Overall Study | Lack of Efficacy | 2 | 2 |
| Overall Study | Physician Decision | 1 | 1 |
| Overall Study | Protocol Violation | 0 | 1 |
Baseline characteristics
| Characteristic | Semi-solidification With Nutrient | Standard Enteral Nutrition | Total |
|---|---|---|---|
| Age, Continuous | 54.93 years STANDARD_DEVIATION 20.96 | 52.14 years STANDARD_DEVIATION 13.77 | 53.54 years STANDARD_DEVIATION 17.45 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 14 Participants | 14 Participants | 28 Participants |
| NRS 2002 | 3.14 units on a scale STANDARD_DEVIATION 0.77 | 2.86 units on a scale STANDARD_DEVIATION 0.95 | 3 units on a scale STANDARD_DEVIATION 0.86 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 14 Participants | 14 Participants | 28 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment China | 14 participants | 14 participants | 28 participants |
| Sex: Female, Male Female | 5 Participants | 5 Participants | 10 Participants |
| Sex: Female, Male Male | 9 Participants | 9 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 14 | 3 / 14 |
| other Total, other adverse events | 0 / 14 | 0 / 14 |
| serious Total, serious adverse events | 0 / 14 | 0 / 14 |
Outcome results
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
Time frame: 3 days after receiving enteral nutrition
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intermittent Feeding With Semi-solid Nutrients | the Ratio of the Enteral Nutrition | 0.98 ratio | Standard Deviation 0.067 |
| Standard Enteral Feeding | the Ratio of the Enteral Nutrition | 0.73 ratio | Standard Deviation 0.15 |
Secondary
30-days Mortality
dead within 30 days in ICU
Time frame: 30 days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intermittent Feeding With Semi-solid Nutrients | 30-days Mortality | The number of deaths within 30 days after ICU | 3 participants |
| Intermittent Feeding With Semi-solid Nutrients | 30-days Mortality | The number of live after 30 days in ICU | 11 participants |
| Standard Enteral Feeding | 30-days Mortality | The number of deaths within 30 days after ICU | 2 participants |
| Standard Enteral Feeding | 30-days Mortality | The number of live after 30 days in ICU | 12 participants |
p-value: 0.05Chi-squared, Corrected
Secondary
Length of Hospital Stay (LOS)
every participators stayed in hospital
Time frame: 30 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intermittent Feeding With Semi-solid Nutrients | Length of Hospital Stay (LOS) | 20.07 days | Standard Deviation 25.71 |
| Standard Enteral Feeding | Length of Hospital Stay (LOS) | 14.36 days | Standard Deviation 7.59 |
p-value: <0.05Chi-squared, Corrected
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intermittent Feeding With Semi-solid Nutrients | the Glycemic Variability(GV) | 1d-0h | 7.514 mmol/l | Standard Deviation 2.2309 |
| Intermittent Feeding With Semi-solid Nutrients | the Glycemic Variability(GV) | 1d-4h | 8.336 mmol/l | Standard Deviation 2.1653 |
| Intermittent Feeding With Semi-solid Nutrients | the Glycemic Variability(GV) | 1d-8h | 9.229 mmol/l | Standard Deviation 3.2587 |
| Intermittent Feeding With Semi-solid Nutrients | the Glycemic Variability(GV) | 1d-12h | 9.342857 mmol/l | Standard Deviation 3.1353357 |
| Intermittent Feeding With Semi-solid Nutrients | the Glycemic Variability(GV) | 1d-16h | 8.635714 mmol/l | Standard Deviation 2.4069154 |
| Intermittent Feeding With Semi-solid Nutrients | the Glycemic Variability(GV) | 1d-20h | 8.064286 mmol/l | Standard Deviation 1.97274 |
| Intermittent Feeding With Semi-solid Nutrients | the Glycemic Variability(GV) | 2d-0h | 8.436 mmol/l | Standard Deviation 2.2016 |
| Intermittent Feeding With Semi-solid Nutrients | the Glycemic Variability(GV) | 2d-4h | 8.857 mmol/l | Standard Deviation 2.5687 |
| Intermittent Feeding With Semi-solid Nutrients | the Glycemic Variability(GV) | 2d-8h | 10.471 mmol/l | Standard Deviation 3.0698 |
| Intermittent Feeding With Semi-solid Nutrients | the Glycemic Variability(GV) | 2d-12h | 9.543 mmol/l | Standard Deviation 3.5213 |
| Intermittent Feeding With Semi-solid Nutrients | the Glycemic Variability(GV) | 2d-16h | 9.343 mmol/l | Standard Deviation 3.4469 |
| Intermittent Feeding With Semi-solid Nutrients | the Glycemic Variability(GV) | 2d-20h | 8.807 mmol/l | Standard Deviation 3.413 |
| Intermittent Feeding With Semi-solid Nutrients | the Glycemic Variability(GV) | 3d-0h | 8.135714 mmol/l | Standard Deviation 2.5548166 |
| Intermittent Feeding With Semi-solid Nutrients | the Glycemic Variability(GV) | 3d-4h | 8.579 mmol/l | Standard Deviation 2.8282 |
| Intermittent Feeding With Semi-solid Nutrients | the Glycemic Variability(GV) | 3d-8h | 9.121 mmol/l | Standard Deviation 2.8011 |
| Intermittent Feeding With Semi-solid Nutrients | the Glycemic Variability(GV) | 3d-12h | 8.721 mmol/l | Standard Deviation 2.8072 |
| Intermittent Feeding With Semi-solid Nutrients | the Glycemic Variability(GV) | 3d-16h | 9.328571 mmol/l | Standard Deviation 3.2257208 |
| Intermittent Feeding With Semi-solid Nutrients | the Glycemic Variability(GV) | 3d-20h | 8.250000 mmol/l | Standard Deviation 2.3299884 |
| Standard Enteral Feeding | the Glycemic Variability(GV) | 3d-4h | 9.486 mmol/l | Standard Deviation 3.7223 |
| Standard Enteral Feeding | the Glycemic Variability(GV) | 1d-0h | 8.457 mmol/l | Standard Deviation 2.9456 |
| Standard Enteral Feeding | the Glycemic Variability(GV) | 2d-12h | 9.514 mmol/l | Standard Deviation 3.6367 |
| Standard Enteral Feeding | the Glycemic Variability(GV) | 1d-4h | 9.700 mmol/l | Standard Deviation 3.1001 |
| Standard Enteral Feeding | the Glycemic Variability(GV) | 3d-20h | 7.957143 mmol/l | Standard Deviation 2.0129253 |
| Standard Enteral Feeding | the Glycemic Variability(GV) | 1d-8h | 9.664 mmol/l | Standard Deviation 3.1023 |
| Standard Enteral Feeding | the Glycemic Variability(GV) | 2d-16h | 8.821 mmol/l | Standard Deviation 3.6413 |
| Standard Enteral Feeding | the Glycemic Variability(GV) | 1d-12h | 8.985714 mmol/l | Standard Deviation 3.284663 |
| Standard Enteral Feeding | the Glycemic Variability(GV) | 3d-8h | 8.879 mmol/l | Standard Deviation 3.0238 |
| Standard Enteral Feeding | the Glycemic Variability(GV) | 1d-16h | 8.992857 mmol/l | Standard Deviation 3.1086639 |
| Standard Enteral Feeding | the Glycemic Variability(GV) | 2d-20h | 7.807 mmol/l | Standard Deviation 2.8073 |
| Standard Enteral Feeding | the Glycemic Variability(GV) | 1d-20h | 8.721429 mmol/l | Standard Deviation 2.5137097 |
| Standard Enteral Feeding | the Glycemic Variability(GV) | 3d-16h | 8.935714 mmol/l | Standard Deviation 2.2210902 |
| Standard Enteral Feeding | the Glycemic Variability(GV) | 2d-0h | 8.686 mmol/l | Standard Deviation 2.9493 |
| Standard Enteral Feeding | the Glycemic Variability(GV) | 3d-0h | 8.250000 mmol/l | Standard Deviation 4.3164711 |
| Standard Enteral Feeding | the Glycemic Variability(GV) | 2d-4h | 9.450 mmol/l | Standard Deviation 3.1889 |
| Standard Enteral Feeding | the Glycemic Variability(GV) | 3d-12h | 9.429 mmol/l | Standard Deviation 3.0648 |
| Standard Enteral Feeding | the Glycemic Variability(GV) | 2d-8h | 9.064 mmol/l | Standard Deviation 2.8527 |
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.
Time frame: 3 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intermittent Feeding With Semi-solid Nutrients | the Patient of Feeding Intolerance（FI） | 8 participants |
| Standard Enteral Feeding | the Patient of Feeding Intolerance（FI） | 2 participants |
Comparison: P=.046p-value: 0.05t-test, 2 sided
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
Time frame: 7 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intermittent Feeding With Semi-solid Nutrients | the Patients With Lung Infection | 8 participants |
| Standard Enteral Feeding | the Patients With Lung Infection | 7 participants |
p-value: 0.05t-test, 2 sided