- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07278167
Analysis of Risk Factors and Prognostic Predictive Value in Sepsis Patients With Nutritional Risk
November 30, 2025 updated by: The Affiliated Hospital of Inner Mongolia Medical University
Analysis of Risk Factors and Predictive Value for 28-Day Mortality in Patients With Sepsis and Nutritional Risk
Sepsis is a common critical illness in intensive care units, characterized by systemic inflammatory response, immune dysfunction, microcirculatory issues, and multi-organ failure.
These factors lead to high mortality rates and poor prognoses for patients.
Nutritional risk is a significant complication in patients with sepsis, with a prevalence of 38% - 78.
Sepsis-induced hypermetabolism and hypercatabolism result in increased energy expenditure and accelerated protein breakdown in affected patients, which subsequently exacerbates the risk of malnutrition.
Malnutrition weakens immune function, reduces resistance to infections, and impairs immune regulation in sepsis patients.
It worsens organ dysfunction, prolongs ICU hospitalization, and increases morbidity and mortality rates.
Early identification and intervention for potential risk factors in patients with sepsis, particularly those with nutritional risk, is crucial for enhancing their prognosis.
There is a notable lack of sensitive indicators for assessing the prognosis of sepsis patients at nutritional risk.
Recent studies have begun exploring physical assessment measures in ICU settings as accessible and noninvasive tools for evaluation.
This study aims to investigate the predictive value of nutritional laboratory indicators and physical measurements regarding the 28-day outcomes of ICU patients with sepsis and nutritional risk, providing a foundation for early clinical intervention.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
400
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Hohhot, China
- Jing Lin
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Sepsis with nutritional risk
Description
Inclusion Criteria:
- Met the diagnostic criteria for sepsis 3.0
- Met the diagnostic criteria for nutritional risk (NRS-2002 score ≥ 3)
- ICU stay≥2 days
- Age ≥ 18
Exclusion Criteria:
- Edema
- Tumor patients
- Pregnancy
- Lack of complete laboratory results
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
survivors/non-survivors
|
Retrospective data analysis, no intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
28-day clinical outcome
Time Frame: 28day
|
28day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2025
Primary Completion (Actual)
July 1, 2025
Study Completion (Actual)
July 1, 2025
Study Registration Dates
First Submitted
November 30, 2025
First Submitted That Met QC Criteria
November 30, 2025
First Posted (Actual)
December 11, 2025
Study Record Updates
Last Update Posted (Actual)
December 11, 2025
Last Update Submitted That Met QC Criteria
November 30, 2025
Last Verified
November 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AHInnerMongolia-NT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.