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Enrolling by invitation

NCT Number: NCT07811544

Immune Evaluation for Postoperative Sepsis-AKI

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.

Enrolling by invitation

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing Chao Yang Hospital

Beijing, Beijing Municipality, 100020, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Not applicable- observational study

Other

Not applicable- observational study

Primary outcomes

  1. Incidence of AKI within 7 days after ICU admission

    Time frame: 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 outcomes

  1. 28-Day All-Cause Mortality After Enrollment

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Beijing Chao Yang Hospital

Other

Collaborators

  • Beijing Jishuitan Hospital

Registry information

Official study title

Development of an Immune Evaluation System for Postoperative Sepsis-Associated Acute Kidney Injury

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Sep 10, 2026
Registry last updated
Sep 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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