Immune Evaluation for Postoperative Sepsis-AKI

N/AEnrolling By InvitationNCT07811544

Beijing Chao Yang Hospital800 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

800

Conditions

Sepsis Acute Kidney Injury

Interventions

Not applicable- observational studyOTHER

Not applicable- observational study

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Beijing Chao Yang Hospital

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

Incidence of AKI within 7 days after ICU admission

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.

Time frame: From Day 1 to Day 7 after enrollment

Secondary Outcomes

28-Day All-Cause Mortality 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.

Time frame: From Day 1 through Day 28 after enrollment

Data from ClinicalTrials.gov

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