NCT06943326

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 8, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

April 24, 2025

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
Last Updated

April 24, 2025

Status Verified

April 1, 2025

Enrollment Period

2 months

First QC Date

April 8, 2025

Last Update Submit

April 16, 2025

Conditions

Keywords

sepsisintensive carenutrition

Outcome Measures

Primary Outcomes (12)

  • 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

Interventions

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mehmet Akif Inan Training and Research Hospital

Sanliurfa, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

SepsisMalnutrition

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsNutrition DisordersNutritional and Metabolic Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Week
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

April 8, 2025

First Posted

April 24, 2025

Study Start

November 1, 2024

Primary Completion

January 1, 2025

Study Completion

May 1, 2025

Last Updated

April 24, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

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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