SepsisNCT06943326
Effects of Enteral Nutrition Content on Disease Progression in Sepsis Patients
An observational study of Sepsis and Nutritional Deficiency, run by Inonu University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to investigate the effects of enteral nutrition content on disease progression in sepsis patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Nutritional Deficiency
- What is being tested?
- nutrition monitoring
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2024to 1 May 2025
- How long will I take part?
- 1 Week
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Being diagnosed with sepsis and being able to receive enteral nutrition 24 hours after starting treatment in the intensive care unit
Who cannot join
- chronic liver disease, chronic renal failure, active cancer or parenteral nutrition
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Mehmet Akif Inan Training and Research Hospital
Sanliurfa
HAKAN TOĞUÇ, 05073625100, hakan.toguc@inonu.edu.tr
About this study
The aim of this study was to investigate the effects of enteral nutrition content on disease progression in sepsis patients.
Read the 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.
- Conditions
- Sepsis, Nutritional Deficiency
- Being tested
- nutrition monitoring
- Keywords
- sepsis, intensive care, nutrition
- Medical subject headings
- Sepsis, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nutrition monitoringOther
There is no investigator intervention in the study. Patients' nutrition is recorded for one week from the beginning of the study.
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Serum Glucose Level
Change in fasting blood glucose level (mg/dL) from baseline to Day 7.
Measured: Baseline and Day 7
Change in Serum Albumin Level
Change in serum albumin concentration (g/dL) from baseline to Day 7.
Measured: Baseline and Day 7
Change in Serum C-Reactive Protein (CRP) Level
Change in serum CRP level (mg/L) from baseline to Day 7.
Measured: Baseline and Day 7
Change in Hemoglobin Level
Change in hemoglobin concentration (g/dL) from baseline to Day 7.
Measured: Baseline and Day 7
Change in Serum Urea Level
Change in serum urea concentration (g/dL) from baseline to Day 7.
Measured: Baseline and Day 7
Change in Serum Creatinine Level
Change in serum creatinine concentration (g/dL) from baseline to Day 7.
Measured: Baseline and Day 7
Change in Absolute Lymphocyte Count
Change in absolute lymphocyte count () from baseline to Day 7.
Measured: Baseline and Day 7
Change in Total Leukocyte Count
Change in total leukocyte count (10^3/µL) from baseline to Day 7.
Measured: Baseline and Day 7
Change in Monocyte Count
Change in absolute monocyte count (10^3/µL) from baseline to Day 7.
Measured: Baseline and Day 7
Change in Neutrophil Count
Change in absolute neutrophil count (10^3/µL) from baseline to Day 7.
Measured: Baseline and Day 7
Change in Eosinophil Count
Change in absolute eosinophil count (10^3/µL) from baseline to Day 7.
Measured: Baseline and Day 7
Change in Basophil Count
Change in absolute basophil count (10^3/µL) from baseline to Day 7.
Measured: Baseline and Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2025
- Study start1 Nov 2024
- Primary completion1 Jan 2025
- Study completion1 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Inonu UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
- Target duration
- 1 Week
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, HAKAN TOĞUÇ, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06943326
- Sponsor's protocol ID
- Inonu-NAD-HT-02
- Status last verified
- Apr 2025
- First submitted
- 8 Apr 2025
- Last updated
- 24 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Enteral Nutrition Content on Disease Progression in Sepsis Patients
- ClinicalTrials.gov ID
- NCT06943326
- Acronym / sponsor ID
- Inonu-NAD-HT-02
- Conditions
- Sepsis, Nutritional Deficiency
- Keywords
- sepsis, intensive care, nutrition
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 24 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Week
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Being diagnosed with sepsis and being able to receive enteral nutrition 24 hours after starting treatment in the intensive care unit
Key exclusion criteria (1 listed)
- chronic liver disease, chronic renal failure, active cancer or parenteral nutrition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nutrition monitoringThere is no investigator intervention in the study. Patients' nutrition is recorded for one week from the beginning of the study. | Other | – |
Primary outcome
Change in Serum Glucose Level
Time frame: Baseline and Day 7
Change in fasting blood glucose level (mg/dL) from baseline to Day 7.
Change in Serum Albumin Level
Time frame: Baseline and Day 7
Change in serum albumin concentration (g/dL) from baseline to Day 7.
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.
Change in Hemoglobin Level
Time frame: Baseline and Day 7
Change in hemoglobin concentration (g/dL) from baseline to Day 7.
Change in Serum Urea Level
Time frame: Baseline and Day 7
Change in serum urea concentration (g/dL) from baseline to Day 7.
Change in Serum Creatinine Level
Time frame: Baseline and Day 7
Change in serum creatinine concentration (g/dL) from baseline to Day 7.
Change in Absolute Lymphocyte Count
Time frame: Baseline and Day 7
Change in absolute lymphocyte count () from baseline to Day 7.
Change in Total Leukocyte Count
Time frame: Baseline and Day 7
Change in total leukocyte count (10^3/µL) from baseline to Day 7.
Change in Monocyte Count
Time frame: Baseline and Day 7
Change in absolute monocyte count (10^3/µL) from baseline to Day 7.
Change in Neutrophil Count
Time frame: Baseline and Day 7
Change in absolute neutrophil count (10^3/µL) from baseline to Day 7.
Change in Eosinophil Count
Time frame: Baseline and Day 7
Change in absolute eosinophil count (10^3/µL) from baseline to Day 7.
Change in Basophil Count
Time frame: Baseline and Day 7
Change in absolute basophil count (10^3/µL) from baseline to Day 7.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2025.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and Nutritional Deficiency, run by Inonu University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact HAKAN TOĞUÇ (+905073625100, hakan.toguc@inonu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Serum Glucose Level (time frame: Baseline and Day 7). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2025.