NCT07278167

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

March 1, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 30, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 11, 2025

Completed
Last Updated

December 11, 2025

Status Verified

November 1, 2025

Enrollment Period

4 months

First QC Date

November 30, 2025

Last Update Submit

November 30, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 28-day clinical outcome

    28day

Study Arms (1)

survivors/non-survivors

Other: Retrospective data analysis, no intervention

Interventions

Retrospective data analysis, no intervention

survivors/non-survivors

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Sepsis with nutritional risk

You may qualify if:

  • 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

You may not qualify if:

  • Edema
  • Tumor patients
  • Pregnancy
  • Lack of complete laboratory results

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jing Lin

Hohhot, China

Location

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2025

First Posted

December 11, 2025

Study Start

March 1, 2025

Primary Completion

July 1, 2025

Study Completion

July 1, 2025

Last Updated

December 11, 2025

Record last verified: 2025-11

Locations