The Effects of Bolus, Intermittent and Continuous Enteral Feeding on Blood Glucose and Feeding Intolerance in ICU Patients With Sepsis

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Enteral Feeding Intolerance

Intervention / Treatment
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* Other: enteral feeding
* Procedure: blood glucose measurements
* Procedure: Evaluation of feeding intolerance with gastric residue


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: bolus feeding group<br>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. | Other: enteral feeding<br>* 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.<br>Procedure: blood glucose measurements<br>* 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.<br>Procedure: Evaluation of feeding intolerance with gastric residue<br>* 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.<br>|
| Experimental: intermittent feeding group<br>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. | Other: enteral feeding<br>* 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.<br>Procedure: blood glucose measurements<br>* 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.<br>Procedure: Evaluation of feeding intolerance with gastric residue<br>* 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.<br>|
| Active Comparator: continous feeding group<br>The same method was applied as in Group 2. However, after 24:00, feeding was not interrupted and continued as the 4th cycle. | Other: enteral feeding<br>* 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.<br>Procedure: blood glucose measurements<br>* 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.<br>Procedure: Evaluation of feeding intolerance with gastric residue<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| effect of enteral feeding methods on blood glucose levels | Evaluation of hypo/hyperglycemia development by measuring blood glucose level 4 times a day | for 7 days after the start of feeding | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | during the 7th day with the start of feeding | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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plasma glucose levels,, enteral feeding intolerance, enteral feeding methods, sepsis