Immune Evaluation for Postoperative Sepsis-AKI

NCT07811544 | Enrolling By Invitation DMC

• 1 other identifier: 2026Postoperative SA-AKI
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

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.

Conditions

Sepsis; Acute Kidney Injury

Outcome Measures

Primary Outcomes (1)

• 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.

  From Day 1 to Day 7 after enrollment

Secondary Outcomes (1)

• 28-Day All-Cause Mortality After Enrollment

  From Day 1 through Day 28 after enrollment

Study Arms (2)

Derivation Cohort

Validation Cohort

Other: Not applicable- observational study

Interventions

Not applicable- observational study OTHER

Not applicable- observational study

Validation Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to the ICU

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Beijing Chao Yang Hospital: lead
• Beijing Jishuitan Hospital: collaborator

Study Sites (1)

Beijing Chao Yang Hospital

Beijing, Beijing Municipality, 100020, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

Sepsis; Acute Kidney Injury

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 28 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2026
• First Posted: September 10, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: September 11, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)