Clinical trial NCT06943326: Effects of Enteral Nutrition Content on Disease Progression in Sepsis Patients
Official title: Effects of Enteral Nutrition Content on Disease Progression in Sepsis Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sepsis
Nutritional Deficiency
Keywords: sepsis
intensive care
nutrition
Lead sponsor: Inonu University
Sponsor class: OTHER
First posted: 2025-04-24
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with sepsis who were older than 18 years and receiving enteral nutrition and receiving treatment in the Intensive Care Unit of Mehmet Akif Inan Training and Research Hospital were included.

Brief summary: The aim of this study was to investigate the effects of enteral nutrition content on disease progression in sepsis patients.

Detailed description: Sepsis is a serious health problem with high mortality and morbidity rates worldwide. Over-activation of the inflammatory response and related organ dysfunctions are the main characteristics of sepsis. Rapid diagnosis and effective management are of vital importance in the treatment of sepsis. In this context, the role of enteral nutrition in the progression of the disease is increasingly being investigated.

Enteral nutrition is the practice of providing nutrients through the gastrointestinal tract and is a preferred method compared to parenteral nutrition in critical illnesses, especially in sepsis. The enteral route may reduce the risk of microbial translocation and modulate the immune system by maintaining intestinal integrity. Therefore, the content of enteral nutrition in sepsis patients may significantly affect the course of the disease.

Existing literature examines the effects of different enteral nutrient contents on patients with sepsis, with a particular focus on how macro- and micronutrient compositions can modulate inflammatory and immune responses. This study aims to examine the effects of enteral nutritional content on disease progression in patients with sepsis.

This prospective cross-sectional study will be conducted with patients diagnosed with sepsis being treated in the intensive care unit of Mehmet Akif Inan Training and Research Hospital. The study was planned to evaluate the effect of energy and nutrient intake on disease outcomes. Within the scope of the study, 60 patients diagnosed with sepsis will be followed up according to treatment in intensive care unit.

The inclusion criteria of the study include being diagnosed with sepsis and being 24 hours after the start of treatment in the intensive care unit and being able to receive enteral nutrition. Exclusion criteria included having chronic liver disease, chronic renal failure, active cancer disease and being on parenteral nutrition.

Data Collection General and health information of the participants will be obtained from the patient file. Nutritional information of the participants will be calculated by the researcher by noting the amount of food and formula taken with enteral nutrition for 7 days and 7-day food consumption will be calculated.

Biochemical and inflammatory data including glucose, albumin, CRP, haemoglobin, urea, creatinine, lymphocytes, leukocytes, monocytes, neutrophils, eosinophils, basophils will be obtained from the patient records at the beginning of the study and after 7 days.

Eligibility criteria: Inclusion Criteria:

* Being diagnosed with sepsis and being able to receive enteral nutrition 24 hours after starting treatment in the intensive care unit

Exclusion Criteria:

* chronic liver disease, chronic renal failure, active cancer or parenteral nutrition

Primary outcomes:
measure: Change in Serum Glucose Level
timeFrame: Baseline and Day 7
measure: Change in Serum Albumin Level
timeFrame: Baseline and Day 7
measure: Change in Serum C-Reactive Protein (CRP) Level
timeFrame: Baseline and Day 7
measure: Change in Hemoglobin Level
timeFrame: Baseline and Day 7
measure: Change in Serum Urea Level
timeFrame: Baseline and Day 7
measure: Change in Serum Creatinine Level
timeFrame: Baseline and Day 7
measure: Change in Absolute Lymphocyte Count
timeFrame: Baseline and Day 7
measure: Change in Total Leukocyte Count
timeFrame: Baseline and Day 7
measure: Change in Monocyte Count
timeFrame: Baseline and Day 7
measure: Change in Neutrophil Count
timeFrame: Baseline and Day 7
measure: Change in Eosinophil Count
timeFrame: Baseline and Day 7
measure: Change in Basophil Count
timeFrame: Baseline and Day 7
Secondary outcomes:
Other outcomes:
Locations:
city: Şanlıurfa
country: Turkey
facility: Mehmet Akif Inan Training and Research Hospital
Study officials:
References: