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

Enteral Feeding Intolerance Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05812664
• Other study ID #: ENTERAL FEEDING
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 2023
• Est. completion date: December 2023

Study information

• Verified date: December 2023
• Source: Umraniye Education and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 93
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Enteral Feeding Intolerance
• Sepsis

Intervention

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.
• 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.

Locations

Country	Name	City	State
Turkey	Umraniye Education and research hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Umraniye Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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