Acute Kidney Injury, Sepsis
Conditions
Brief summary
This prospective, multicenter, observational cohort study plans to enroll over 800 patients with postoperative sepsis from the ICUs of two tertiary hospitals in Beijing. The study will establish a clinical database and biobank for sepsis-associated acute kidney injury (SA-AKI), characterize clinical and immune phenotypes, and develop an immune evaluation system. Using multi-omics and single-cell sequencing, we aim to identify novel immune biomarker panels and explore early warning and risk-stratification strategies based on immune profiling.
Interventions
OTHERNot applicable- observational study
Not applicable- observational study
Sponsors
Beijing Chao Yang Hospital
Beijing Jishuitan Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years; * Admitted to the ICU due to clinical necessity after surgical procedure; * Expected ICU length of stay \> 48 hours; * Sepsis diagnosed according to the Sepsis-3.0 criteria; * Patient or legally authorized representative is able to understand the study protocol, willing to participate, and provides written informed consent.
Exclusion criteria
* Patients with active malignancy undergoing chemotherapy, radiotherapy, or targeted therapy; patients with immune diseases receiving immunosuppressive or targeted agents; or patients who developed neutropenia/lymphopenia prior to sepsis onset due to hematologic disorders or receipt of immunosuppressive therapy; * Patients in a moribund state with no resuscitative intent; patients with do-not-resuscitate (DNR) or withdrawal-of-care orders; * Patients who do not meet the inclusion criteria.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of AKI within 7 days after ICU admission | From Day 1 to Day 7 after enrollment | AKI incidence is calculated as the number of patients who develop AKI divided by the total number of enrolled patients. AKI will be diagnosed and staged according to KDIGO 2012 criteria, based on serum creatinine and urine output measurements. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 28-Day All-Cause Mortality After Enrollment | From Day 1 through Day 28 after enrollment | All-cause mortality within 28 days after enrollment, calculated as the number of patients who die during Days 1-28 divided by the total number of enrolled patients. Vital status will be ascertained through medical records or follow-up telephone calls. |
Countries
China
Outcome results
None listed