SepsisNCT07278167
Analysis of Risk Factors and Prognostic Predictive Value in Sepsis Patients With Nutritional Risk
An observational study of Sepsis and Nutritional Risk, run by The Affiliated Hospital of Inner Mongolia Medical University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Nutritional Risk
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2025to 1 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Sepsis with nutritional risk
Who may be able to join
- 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
Who cannot join
- Edema
- Tumor patients
- Pregnancy
- Lack of complete laboratory results
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Sepsis, Nutritional Risk
- Being tested
- Retrospective data analysis, no intervention
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retrospective data analysis, no interventionOther
Retrospective data analysis, no intervention
| Study group | Role | What they receive |
|---|---|---|
| survivors/non-survivors | Not described Receives: Other: Retrospective data analysis, no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
28-day clinical outcome
Measured: 28day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2025
- Study start1 Mar 2025
- Primary completion1 Jul 2025
- Study completion1 Jul 2025
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.
- 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
- Retrospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Inner Mongolia Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07278167
- Sponsor's protocol ID
- AHInnerMongolia-NT
- Status last verified
- Nov 2025
- First submitted
- 30 Nov 2025
- Last updated
- 11 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Risk Factors and Predictive Value for 28-Day Mortality in Patients With Sepsis and Nutritional Risk
- ClinicalTrials.gov ID
- NCT07278167
- Acronym / sponsor ID
- AHInnerMongolia-NT
- Conditions
- Sepsis, Nutritional Risk
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- The Affiliated Hospital of Inner Mongolia Medical UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 1 Jul 2025 (actual)
- First posted
- 11 Dec 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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| survivors/non-survivors | – | Other: Retrospective data analysis, no intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Sepsis with nutritional risk
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Edema
- Tumor patients
- Pregnancy
- Lack of complete laboratory results
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 |
|---|---|---|
| Retrospective data analysis, no interventionRetrospective data analysis, no intervention | Other | survivors/non-survivors |
Primary outcome
28-day clinical outcome
Time frame: 28day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2025.
- Individual participant dataSharing planned: Undecided
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A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
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Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
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Thymosin Alpha 1 and IgM Levels in Sepsis
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Risk, run by The Affiliated Hospital of Inner Mongolia Medical University at 1 site in China.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 11 Dec 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
28-day clinical outcome (time frame: 28day). 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 11 Dec 2025.