Trial Outcomes & Findings for A More Physiological Feeding Process in ICU:the Intermittent Infusion With Semi-solidification of Nutrients (NCT NCT03017079)
NCT ID: NCT03017079
Last Updated: 2021-11-02
Results Overview
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
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
3 days after receiving enteral nutrition
Results posted on
2021-11-02
Participant Flow
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
14
|
14
|
|
Overall Study
NOT COMPLETED
|
6
|
6
|
Reasons for withdrawal
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
Physician Decision
|
1
|
1
|
|
Overall Study
Death
|
3
|
2
|
|
Overall Study
Lack of Efficacy
|
2
|
2
|
|
Overall Study
Protocol Violation
|
0
|
1
|
Baseline Characteristics
A More Physiological Feeding Process in ICU:the Intermittent Infusion With Semi-solidification of Nutrients
Baseline characteristics by cohort
| Measure |
Semi-solidification With Nutrient
n=14 Participants
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
|
Standard Enteral Nutrition
n=14 Participants
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
|
Total
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.93 years
STANDARD_DEVIATION 20.96 • n=5 Participants
|
52.14 years
STANDARD_DEVIATION 13.77 • n=7 Participants
|
53.54 years
STANDARD_DEVIATION 17.45 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
China
|
14 participants
n=5 Participants
|
14 participants
n=7 Participants
|
28 participants
n=5 Participants
|
|
NRS 2002
|
3.14 units on a scale
STANDARD_DEVIATION 0.77 • n=5 Participants
|
2.86 units on a scale
STANDARD_DEVIATION 0.95 • n=7 Participants
|
3 units on a scale
STANDARD_DEVIATION 0.86 • n=5 Participants
|
PRIMARY outcome
Timeframe: 3 days after receiving enteral nutritionthe 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
Outcome measures
| Measure |
Intermittent Feeding With Semi-solid Nutrients
n=14 Participants
intermittent feeding with semi-solid nutrients: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
|
Intermittent Feeding
n=14 Participants
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
|
|---|---|---|
|
the Ratio of the Enteral Nutrition
|
0.98 ratio
Standard Deviation 0.067
|
0.73 ratio
Standard Deviation 0.15
|
SECONDARY outcome
Timeframe: 3 daysthe 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.
Outcome measures
| Measure |
Intermittent Feeding With Semi-solid Nutrients
n=14 Participants
intermittent feeding with semi-solid nutrients: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
|
Intermittent Feeding
n=14 Participants
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
|
|---|---|---|
|
the Patient of Feeding Intolerance（FI）
|
8 participants
|
2 participants
|
SECONDARY outcome
Timeframe: 7 dayspatient 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
Outcome measures
| Measure |
Intermittent Feeding With Semi-solid Nutrients
n=14 Participants
intermittent feeding with semi-solid nutrients: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
|
Intermittent Feeding
n=14 Participants
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
|
|---|---|---|
|
the Patients With Lung Infection
|
8 participants
|
7 participants
|
SECONDARY outcome
Timeframe: 30 daysdead within 30 days in ICU
Outcome measures
| Measure |
Intermittent Feeding With Semi-solid Nutrients
n=14 Participants
intermittent feeding with semi-solid nutrients: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
|
Intermittent Feeding
n=14 Participants
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
|
|---|---|---|
|
30-days Mortality
The number of deaths within 30 days after ICU
|
3 participants
|
2 participants
|
|
30-days Mortality
The number of live after 30 days in ICU
|
11 participants
|
12 participants
|
SECONDARY outcome
Timeframe: 3 daysDivided into three grades:I:GV less than 4mmol/24h; II 4-6mmol/24h;III more than 6mmol/24h
Outcome measures
| Measure |
Intermittent Feeding With Semi-solid Nutrients
n=14 Participants
intermittent feeding with semi-solid nutrients: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
|
Intermittent Feeding
n=14 Participants
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
|
|---|---|---|
|
the Glycemic Variability(GV)
1d-16h
|
8.635714 mmol/l
Standard Deviation 2.4069154
|
8.992857 mmol/l
Standard Deviation 3.1086639
|
|
the Glycemic Variability(GV)
1d-20h
|
8.064286 mmol/l
Standard Deviation 1.9727400
|
8.721429 mmol/l
Standard Deviation 2.5137097
|
|
the Glycemic Variability(GV)
3d-16h
|
9.328571 mmol/l
Standard Deviation 3.2257208
|
8.935714 mmol/l
Standard Deviation 2.2210902
|
|
the Glycemic Variability(GV)
3d-20h
|
8.250000 mmol/l
Standard Deviation 2.3299884
|
7.957143 mmol/l
Standard Deviation 2.0129253
|
|
the Glycemic Variability(GV)
1d-0h
|
7.514 mmol/l
Standard Deviation 2.2309
|
8.457 mmol/l
Standard Deviation 2.9456
|
|
the Glycemic Variability(GV)
1d-4h
|
8.336 mmol/l
Standard Deviation 2.1653
|
9.700 mmol/l
Standard Deviation 3.1001
|
|
the Glycemic Variability(GV)
1d-8h
|
9.229 mmol/l
Standard Deviation 3.2587
|
9.664 mmol/l
Standard Deviation 3.1023
|
|
the Glycemic Variability(GV)
1d-12h
|
9.342857 mmol/l
Standard Deviation 3.1353357
|
8.985714 mmol/l
Standard Deviation 3.2846630
|
|
the Glycemic Variability(GV)
2d-0h
|
8.436 mmol/l
Standard Deviation 2.2016
|
8.686 mmol/l
Standard Deviation 2.9493
|
|
the Glycemic Variability(GV)
2d-4h
|
8.857 mmol/l
Standard Deviation 2.5687
|
9.450 mmol/l
Standard Deviation 3.1889
|
|
the Glycemic Variability(GV)
2d-8h
|
10.471 mmol/l
Standard Deviation 3.0698
|
9.064 mmol/l
Standard Deviation 2.8527
|
|
the Glycemic Variability(GV)
2d-12h
|
9.543 mmol/l
Standard Deviation 3.5213
|
9.514 mmol/l
Standard Deviation 3.6367
|
|
the Glycemic Variability(GV)
2d-16h
|
9.343 mmol/l
Standard Deviation 3.4469
|
8.821 mmol/l
Standard Deviation 3.6413
|
|
the Glycemic Variability(GV)
2d-20h
|
8.807 mmol/l
Standard Deviation 3.4130
|
7.807 mmol/l
Standard Deviation 2.8073
|
|
the Glycemic Variability(GV)
3d-0h
|
8.135714 mmol/l
Standard Deviation 2.5548166
|
8.250000 mmol/l
Standard Deviation 4.3164711
|
|
the Glycemic Variability(GV)
3d-4h
|
8.579 mmol/l
Standard Deviation 2.8282
|
9.486 mmol/l
Standard Deviation 3.7223
|
|
the Glycemic Variability(GV)
3d-8h
|
9.121 mmol/l
Standard Deviation 2.8011
|
8.879 mmol/l
Standard Deviation 3.0238
|
|
the Glycemic Variability(GV)
3d-12h
|
8.721 mmol/l
Standard Deviation 2.8072
|
9.429 mmol/l
Standard Deviation 3.0648
|
SECONDARY outcome
Timeframe: 30 daysevery participators stayed in hospital
Outcome measures
| Measure |
Intermittent Feeding With Semi-solid Nutrients
n=14 Participants
intermittent feeding with semi-solid nutrients: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
|
Intermittent Feeding
n=14 Participants
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
|
|---|---|---|
|
Length of Hospital Stay (LOS)
|
20.07 days
Standard Deviation 25.71
|
14.36 days
Standard Deviation 7.59
|
Adverse Events
Standard Enteral Nutrition
Serious events: 0 serious events
Other events: 0 other events
Deaths: 2 deaths
Semi-solidification With Nutrient
Serious events: 0 serious events
Other events: 0 other events
Deaths: 3 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr
THE SECOND AFFILIATED HOSPITAL ZHEJIANG UNIVERSITY SCHOOL OF MEDICINE
Phone: 18817821529
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place