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

NCT05812664 | Unknown

• 1 other identifier: ENTERAL FEEDİNG
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

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.

Conditions

Enteral Feeding Intolerance

Keywords

plasma glucose levels,; enteral feeding intolerance; enteral feeding methods; sepsis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• feeding intolerance

  during the 7th day with the start of feeding

Study Arms (3)

bolus feeding group

EXPERIMENTAL

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; Procedure: blood glucose measurements; Procedure: Evaluation of feeding intolerance with gastric residue

intermittent feeding group

EXPERIMENTAL

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; Procedure: blood glucose measurements; Procedure: Evaluation of feeding intolerance with gastric residue

continous feeding group

ACTIVE COMPARATOR

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; Procedure: blood glucose measurements; Procedure: Evaluation of feeding intolerance with gastric residue

Interventions

enteral feeding OTHER

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.

bolus feeding group; continous feeding group; intermittent feeding group

blood glucose measurements PROCEDURE

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.

bolus feeding group; continous feeding group; intermittent feeding group

Evaluation of feeding intolerance with gastric residue PROCEDURE

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.

bolus feeding group; continous feeding group; intermittent feeding group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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
• negative culture

Sponsors & Collaborators

• Umraniye Education and Research Hospital: lead

Study Sites (1)

Umraniye Education and research hospital

Istanbul, 34111, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Sepsis

Interventions

Enteral Nutrition; Blood Glucose

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Feeding Methods; Therapeutics; Nutritional Support; Nutrition Therapy; Glucose; Hexoses; Monosaccharides; Sugars; Carbohydrates

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: SPECIALIST, MD, Principal Investigator, Principal Assistant

Model Details: 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.

Study Record Dates

• First Submitted: March 11, 2023
• First Posted: April 14, 2023
• Study Start: December 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: December 13, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)