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NCT Number: NCT06943326

Effects of Enteral Nutrition Content on Disease Progression in Sepsis Patients

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

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Key information

Conditions

Sepsis Infections Inflammation Malnutrition Nutrition Disorders Nutritional Deficiency Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mehmet Akif Inan Training and Research Hospital

Sanliurfa, Turkey (Türkiye)

Location status: Recruiting

Location contact

HAKAN TOĞUÇ

CONTACT

[email protected]

05073625100

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

nutrition monitoring

Other

There is no investigator intervention in the study. Patients' nutrition is recorded for one week from the beginning of the study.

Primary outcomes

  1. Change in Serum Glucose Level

    Time frame: Baseline and Day 7

    Change in fasting blood glucose level (mg/dL) from baseline to Day 7.

  2. Change in Serum Albumin Level

    Time frame: Baseline and Day 7

    Change in serum albumin concentration (g/dL) from baseline to Day 7.

  3. Change in Serum C-Reactive Protein (CRP) Level

    Time frame: Baseline and Day 7

    Change in serum CRP level (mg/L) from baseline to Day 7.

  4. Change in Hemoglobin Level

    Time frame: Baseline and Day 7

    Change in hemoglobin concentration (g/dL) from baseline to Day 7.

  5. Change in Serum Urea Level

    Time frame: Baseline and Day 7

    Change in serum urea concentration (g/dL) from baseline to Day 7.

  6. Change in Serum Creatinine Level

    Time frame: Baseline and Day 7

    Change in serum creatinine concentration (g/dL) from baseline to Day 7.

  7. Change in Absolute Lymphocyte Count

    Time frame: Baseline and Day 7

    Change in absolute lymphocyte count () from baseline to Day 7.

  8. Change in Total Leukocyte Count

    Time frame: Baseline and Day 7

    Change in total leukocyte count (10^3/µL) from baseline to Day 7.

  9. Change in Monocyte Count

    Time frame: Baseline and Day 7

    Change in absolute monocyte count (10^3/µL) from baseline to Day 7.

  10. Change in Neutrophil Count

    Time frame: Baseline and Day 7

    Change in absolute neutrophil count (10^3/µL) from baseline to Day 7.

  11. Change in Eosinophil Count

    Time frame: Baseline and Day 7

    Change in absolute eosinophil count (10^3/µL) from baseline to Day 7.

  12. Change in Basophil Count

    Time frame: Baseline and Day 7

    Change in absolute basophil count (10^3/µL) from baseline to Day 7.

Study contacts

Contact information is provided by the study sponsor or research team.

HAKAN TOĞUÇ

CONTACT

[email protected]

+905073625100

Sponsors and collaborators

Lead sponsor

Inonu University

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 24, 2025
Registry last updated
Apr 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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