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A clinical study on the impact of constructing a multi-parameter clinical immune signature stratification system based on lymphocyte subsets on the medium and long-term prognosis of sepsis patients

A clinical study on the impact of constructing a multi-parameter clinical immune signature stratification system based on lymphocyte subsets on the medium and long-term prognosis of sepsis patients

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300070762
Enrollment
Unknown
Registered
2023-04-23
Start date
2023-05-10
Completion date
Unknown
Last updated
2023-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

sepsis

Interventions

Group of infection:no

Sponsors

Shanghai general hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: Eligible subjects to be enrolled in this study must meet all of the following criteria: 1. Age >= 18 years old, <= 85 years old, male and female; 2. Patients in intensive care unit; 3. Confirmed or clinically diagnosed infection; 4. Acute change in sequential organ failure score = 2 points, i.e. ?SOFA score = 2 points (baseline SOFA score for patients with unknown pre-existing organ dysfunction was 0); 5. Infection-related organ failure occurs within 48 hours; Organ failure was defined as a sequential organ failure score (SOFA) of = 2 in at least one organ or system in the circulatory, respiratory, kidney, liver, coagulation, and central nervous systems (i.e., a SOFA score of = 2 points emerging at any point in the screening period).

Exclusion criteria

Exclusion criteria: Subjects who meet any of the following criteria are not eligible for inclusion in this study. 1. Previous history of advanced malignant tumor and end-stage organ failure; 2. Previous history of bone marrow transplantation or solid organ transplantation such as liver and kidney; 3. Patients without lymphocyte count within 24h before and after enrollment; 4. The estimated survival time of patients is less than 72 hours; 5. Pregnant or nursing patients.

Design outcomes

Primary

MeasureTime frame
Incidence of 90-day poor prognosis;

Secondary

MeasureTime frame
Changes in the expression of lymphocyte subsets;28-day/hospitalization / 90-day mortality rate;days in ICU/days in hospital;

Countries

China

Contacts

Public ContactZhou zhigang

Shanghai general hospital

zhou_zhigang1980@163.com+86 177 2120 1371

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026