Clinical trial NCT05812664: 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
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Enteral Feeding Intolerance
Keywords: plasma glucose levels,
enteral feeding intolerance
enteral feeding methods
sepsis
Lead sponsor: Umraniye Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2023-04-14
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SCREENING

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.

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

Primary outcomes:
measure: effect of enteral feeding methods on blood glucose levels
timeFrame: for 7 days after the start of feeding
Secondary outcomes:
measure: feeding intolerance
timeFrame: during the 7th day with the start of feeding
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Umraniye Education and research hospital
Study officials:
References: