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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Enteral Feeding Intolerance
• Intervention / Treatment: Other: enteral feeding; Procedure: blood glucose measurements; Procedure: Evaluation of feeding intolerance with gastric residue

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.

• Study Type: Interventional
• Enrollment (Estimated): 93
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34111
    • Umraniye Education and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: bolus feeding group; 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; 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.; Procedure: blood glucose measurements; 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.; Procedure: Evaluation of feeding intolerance with gastric residue; 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.
Experimental: intermittent feeding group; 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; 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.; Procedure: blood glucose measurements; 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.; Procedure: Evaluation of feeding intolerance with gastric residue; 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.
Active Comparator: continous feeding group; 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; 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.; Procedure: blood glucose measurements; 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.; Procedure: Evaluation of feeding intolerance with gastric residue; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Umraniye Education and Research Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2023
• Primary Completion (Estimated): December 1, 2023
• Study Completion (Estimated): December 1, 2023

Study Registration Dates

• First Submitted: March 11, 2023
• First Submitted That Met QC Criteria: April 11, 2023
• First Posted (Actual): April 14, 2023

Study Record Updates

• Last Update Posted (Estimated): December 13, 2023
• Last Update Submitted That Met QC Criteria: December 12, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: sepsis; enteral feeding intolerance; plasma glucose levels,; enteral feeding methods
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis
• Other Study ID Numbers: ENTERAL FEEDİNG

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: all IPD shared with other researches

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No