Back to resultsThe Effects of Bolus, Intermittent and Continuous Enteral Feeding on Blood Glucose and Feeding Intolerance in ICU Patients With Sepsis
Primary Purpose
Enteral Feeding Intolerance
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
enteral feeding
blood glucose measurements
Evaluation of feeding intolerance with gastric residue
Sponsored by
About this trial
This is an interventional screening trial for Enteral Feeding Intolerance focused on measuring plasma glucose levels,, enteral feeding intolerance, enteral feeding methods, sepsis
Eligibility Criteria
Inclusion Criteria: Hospitalized in ICU for more than 3 days Ages between 18-70 years APACHI II is in the range of 8-25 BMI in the range of 18.5-30 Able to receive enteral nutrition from N/G Intubated on ventilator support No previous diagnosis of Diabetes Mellitus, Those who have not had Gastro intestinal System surgery in the last 6 months Patients not receiving inotropic support not receiving hemodiafiltration No history of allergy to the food used Patients with a focus of infection and/or culture-positive patients diagnosed with sepsis according to Q SOFA (cultures were taken from all patients) Exclusion Criteria: patient's death during the study Taking more than 40 mg of IV steroids daily Increased baseline APACHI II score Development of the patient's need for inotropes Elimination of inclusion criteria negative culture
Sites / Locations
- Umraniye Education and research hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
bolus feeding group
intermittent feeding group
continous feeding group
Arm Description
bolus feeding method;The amount of food to be given for 24 hours calculated for the patient was given as 4 equal amounts for 40 minutes at 4 different times. Starting with 150 cc, the target calorie was reached by increasing 100 cc according to the intolerance before the next feeding hour.
The formula was started as 40 cc/h continuous infusion. It was interrupted after 5 hours. 30 minutes after the break, PGD was measured and intolerance was checked, and if the residue was negative, it was increased by 40 cc. The amount was increased until reaching the amount of formula that should be given for 24 hours calculated for the patient. This cycle was repeated 3 times in 24 hours. At 24:00, it was stopped and feeding was interrupted between 24:00 and 06:00.
The same method was applied as in Group 2. However, after 24:00, feeding was not interrupted and continued as the 4th cycle.
Outcomes
Primary Outcome Measures
effect of enteral feeding methods on blood glucose levels
Evaluation of hypo/hyperglycemia development by measuring blood glucose level 4 times a day
Secondary Outcome Measures
feeding intolerance
effect on feeding intolerance, detection of more than half of the feeding amount will be taken as gastric residue positive so intolerance positive
Full Information
NCT ID
NCT05812664
First Posted
March 11, 2023
Last Updated
April 11, 2023
Sponsor
Umraniye Education and Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05812664
Brief Title
The Effects of Bolus, Intermittent and Continuous Enteral Feeding on Blood Glucose and Feeding Intolerance in ICU Patients With Sepsis
Official Title
The Comparison of Effects of Bolus, Intermittent (Nocturnal Pause) and Continuous Enteral Feeding Methods on Blood Glucose and Feeding Intolerance in ICU Patients With Sepsis, Prospective, Randomized, Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
October 1, 2022 (Actual)
Primary Completion Date
December 1, 2022 (Actual)
Study Completion Date
January 9, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Umraniye Education and Research Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Comparison of the effects of bolus, intermittent and continuous enteral feeding techniques on plasma glucose level and enteral feeding intolerance in adult intensive care unit patients with sepsis.
Detailed Description
in this prospective, controlled trial the main aim is to evaluate the effects of bolus, intermittent and continuous enteral feeding techniques on plasma glucose level in intensive care patients with sepsis diagnosis and to determine whether they are superior to each other in providing norma-glycemia. The secondary aim is to determine the effect of these 3 different enteral feeding techniques on enteral feeding intolerance.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Enteral Feeding Intolerance
Keywords
plasma glucose levels,, enteral feeding intolerance, enteral feeding methods, sepsis
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
If the patients were diagnosed with sepsis in ICU, they were not fed after 24:00, and if the gastric residual measured at 05:00 in the morning was negative, they were included in the study. The patients were examined in 3 groups. The number of samples required to be taken in the power analysis performed (G*power 3.1) was found to be 93 (31 patients in each group) (power value 0.80, alpha error probability=0.05). Patients for the groups were randomly selected by the closed envelope method. A total of 93 envelopes, 31 for each group, were prepared. When the patient was diagnosed with sepsis, if he/she met the inclusion criteria, a random envelope was selected to determine the patient's group. After inclusion in the study, a closed envelope was added again for the patients who should be excluded from the study.
Masking
ParticipantOutcomes Assessor
Masking Description
Limitation of the study; since the patients were intubated and under sedation, they did not know the diet applied to them, but the physician/nurse who examined the residue and PGD knew the diet. Unfortunately, the person who evaluated these two parameters could not be blinded, as it would not be possible to give without showing the feeding methods. However, groups 1-2-3 were reported to the statistician who analyzed the data. The feeding methods of the groups was not reported.
Allocation
Randomized
Enrollment
93 (Actual)
8. Arms, Groups, and Interventions
Arm Title
bolus feeding group
Arm Type
Experimental
Arm Description
bolus feeding method;The amount of food to be given for 24 hours calculated for the patient was given as 4 equal amounts for 40 minutes at 4 different times. Starting with 150 cc, the target calorie was reached by increasing 100 cc according to the intolerance before the next feeding hour.
Arm Title
intermittent feeding group
Arm Type
Experimental
Arm Description
The formula was started as 40 cc/h continuous infusion. It was interrupted after 5 hours. 30 minutes after the break, PGD was measured and intolerance was checked, and if the residue was negative, it was increased by 40 cc. The amount was increased until reaching the amount of formula that should be given for 24 hours calculated for the patient. This cycle was repeated 3 times in 24 hours. At 24:00, it was stopped and feeding was interrupted between 24:00 and 06:00.
Arm Title
continous feeding group
Arm Type
Active Comparator
Arm Description
The same method was applied as in Group 2. However, after 24:00, feeding was not interrupted and continued as the 4th cycle.
Intervention Type
Other
Intervention Name(s)
enteral feeding
Intervention Description
The amount of enteral nutrition that should be given daily was calculated by the nutritionist using the Harris-Benedict formula. Formula at room temperature was given with a nasogastric foley catheter and a feeding pump. The position of the nasogastric Foley catheter in the stomach was confirmed by the PAAC graph when it was first inserted, and by listening before each feeding. Feeding was done in a position with the head at 30 degrees.
Intervention Type
Procedure
Intervention Name(s)
blood glucose measurements
Intervention Description
Blood glucose values were measured in all groups at 06:00, 12:00, 18:00 and 24:00, 4 times a day for 7 days. The sample was taken from the patient's cannula and examined in the biochemistry lab. The targeted range in the measurements was accepted as 70-180 mg/dl.
Intervention Type
Procedure
Intervention Name(s)
Evaluation of feeding intolerance with gastric residue
Intervention Description
gastric residue assessment; 30 minutes after the feeding was stopped, the N/G tube was drained and the amount coming 30 minutes later was evaluated. Residue positive was defined as the return of more than half of the amount of formula in the last cycle. The same was continued without increasing the amount given. If the incoming amount was less than half, the residue was evaluated as negative and the formula was continued by increasing the predetermined amount.
Primary Outcome Measure Information:
Title
effect of enteral feeding methods on blood glucose levels
Description
Evaluation of hypo/hyperglycemia development by measuring blood glucose level 4 times a day
Time Frame
for 7 days after the start of feeding
Secondary Outcome Measure Information:
Title
feeding intolerance
Description
effect on feeding intolerance, detection of more than half of the feeding amount will be taken as gastric residue positive so intolerance positive
Time Frame
during the 7th day with the start of feeding
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Hospitalized in ICU for more than 3 days
Ages between 18-70 years
APACHI II is in the range of 8-25
BMI in the range of 18.5-30
Able to receive enteral nutrition from N/G
Intubated on ventilator support
No previous diagnosis of Diabetes Mellitus,
Those who have not had Gastro intestinal System surgery in the last 6 months
Patients not receiving inotropic support
not receiving hemodiafiltration
No history of allergy to the food used
Patients with a focus of infection and/or culture-positive patients diagnosed with sepsis according to Q SOFA (cultures were taken from all patients)
Exclusion Criteria:
patient's death during the study
Taking more than 40 mg of IV steroids daily
Increased baseline APACHI II score
Development of the patient's need for inotropes
Elimination of inclusion criteria
negative culture
Facility Information:
Facility Name
Umraniye Education and research hospital
City
Istanbul
ZIP/Postal Code
34111
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
all IPD shared with other researches
Learn more about this trial
The Effects of Bolus, Intermittent and Continuous Enteral Feeding on Blood Glucose and Feeding Intolerance in ICU Patients With Sepsis
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