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.

Study Overview

• Status: Recruiting
• Conditions: Sepsis; Nutritional Deficiency
• Intervention / Treatment: Other: nutrition monitoring

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.

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: HAKAN TOĞUÇ; Phone Number: +905073625100; Email: hakan.toguc@inonu.edu.tr

Study Locations

• Turkey
  • Şanlıurfa, Turkey
    • Recruiting
    • Mehmet Akif Inan Training and Research Hospital
    • Contact: HAKAN TOĞUÇ; Phone Number: 05073625100; Email: hakan.toguc@inonu.edu.tr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Serum Glucose Level	Change in fasting blood glucose level (mg/dL) from baseline to Day 7.	Baseline and Day 7
Change in Serum Albumin Level	Change in serum albumin concentration (g/dL) from baseline to Day 7.	Baseline and Day 7
Change in Serum C-Reactive Protein (CRP) Level	Change in serum CRP level (mg/L) from baseline to Day 7.	Baseline and Day 7
Change in Hemoglobin Level	Change in hemoglobin concentration (g/dL) from baseline to Day 7.	Baseline and Day 7
Change in Serum Urea Level	Change in serum urea concentration (g/dL) from baseline to Day 7.	Baseline and Day 7
Change in Serum Creatinine Level	Change in serum creatinine concentration (g/dL) from baseline to Day 7.	Baseline and Day 7
Change in Absolute Lymphocyte Count	Change in absolute lymphocyte count () from baseline to Day 7.	Baseline and Day 7
Change in Total Leukocyte Count	Change in total leukocyte count (10^3/µL) from baseline to Day 7.	Baseline and Day 7
Change in Monocyte Count	Change in absolute monocyte count (10^3/µL) from baseline to Day 7.	Baseline and Day 7
Change in Neutrophil Count	Change in absolute neutrophil count (10^3/µL) from baseline to Day 7.	Baseline and Day 7
Change in Eosinophil Count	Change in absolute eosinophil count (10^3/µL) from baseline to Day 7.	Baseline and Day 7
Change in Basophil Count	Change in absolute basophil count (10^3/µL) from baseline to Day 7.	Baseline and Day 7

Collaborators and Investigators

• Sponsor: Inonu University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2024
• Primary Completion (Actual): January 1, 2025
• Study Completion (Estimated): May 1, 2025

Study Registration Dates

• First Submitted: April 8, 2025
• First Submitted That Met QC Criteria: April 16, 2025
• First Posted (Actual): April 24, 2025

Study Record Updates

• Last Update Posted (Actual): April 24, 2025
• Last Update Submitted That Met QC Criteria: April 16, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: nutrition; intensive care; sepsis
• Additional Relevant MeSH Terms: Pathologic Processes; Nutrition Disorders; Disease Attributes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Malnutrition; Disease Progression; Sepsis; Toxemia
• Other Study ID Numbers: Inonu-NAD-HT-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The data from participants were gathered solely for research objectives, adhering strictly to the ethical principles of confidentiality and protection. As such, it is not available for sharing.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No