Not applicable- observational study / Acute Kidney Injury / Sepsis · Observational Study

Immune Evaluation for Postoperative Sepsis-AKI

ClinicalTrials.gov · September 10, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a prospective multicenter observational cohort study registered at ClinicalTrials.gov that is currently enrolling patients with postoperative sepsis from two tertiary hospitals in Beijing. The study aims to establish a biobank and clinical database, characterize immune phenotypes, and develop immune biomarker panels for risk stratification in sepsis-associated acute kidney injury; no results are yet reported in this registry record.

What was studied

Observational. Sepsis, Acute Kidney Injury; age from 18 Years. Intervention: Derivation Cohort; Validation Cohort. n = 800. 1 site: China.

Key findings

Safety

Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

This is a registry record describing a planned observational cohort study with no reported results; enrollment is ongoing and the study aims to develop biomarkers and phenotyping systems rather than test a defined intervention.

Study design

As stated by the source record.

MethodsCohort model. Prospective time perspective. Primary outcome measure: Incidence of AKI within 7 days after ICU admission (assessed at From Day 1 to Day 7 after enrollment)

DesignObservational

PopulationSepsis, Acute Kidney Injury; age from 18 Years

Sample size800

InterventionDerivation Cohort; Validation Cohort

Setting1 site: China

Reported figures

Quoted from the source exactly as published.

Planned enrollment800

Primary outcome measureIncidence of AKI within 7 days after ICU admission, measured from Day 1 to Day 7 after enrollment

Study typeObservational

Number of sites2 tertiary hospitals in Beijing

Caveats

Registry record only; no results, efficacy data, or outcome measures are reported.
Study is currently enrolling by invitation; completion date and results timeline not provided.
No information provided on data collection methods, outcome adjudication, or statistical analysis plan.
Observational design without control arm limits causal inference; biomarker findings will require validation in independent cohorts.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

moderate

Prospective multicenter observational cohort; no randomization or control arm.

Directness

moderate

Clinically relevant population (postoperative sepsis-AKI) but primary focus on biomarker discovery and phenotyping.

Consistency

insufficient

Registry record; no results reported. Consistency cannot be assessed.

Risk of bias

insufficient

No methods detail provided on data collection, blinding, or potential confounding control.

Sample adequacy

moderate

Planned enrollment 800 participants estimated; sample size appears adequate for cohort descriptive work.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT07811544). This is a study registration, not published results. Lead sponsor: Beijing Chao Yang Hospital. Recruitment status: ENROLLING_BY_INVITATION. Study type: OBSERVATIONAL. Enrollment: 800 participants (ESTIMATED). Conditions: Sepsis, Acute Kidney Injury. Interventions: OTHER: Not applicable- observational study. Primary outcome measures: Incidence of AKI within 7 days after ICU admission , From Day 1 to Day 7 after enrollment. 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.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

NCT07811544Not applicable- observational studyBeijing Chao Yang HospitalAcute Kidney InjurySepsis