NCT07418242

Brief Summary

This project aims to detect novel biomarkers from preoperative and early postoperative serum and urine samples of patients to screen and analyze the risk factors for predicting adverse postoperative renal outcomes in high-risk patients in cardiac surgery.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,491

participants targeted

Target at P75+ for all trials

Timeline
36mo left

Started Feb 2026

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress9%
Feb 2026May 2029

First Submitted

Initial submission to the registry

February 3, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 18, 2026

Completed
5 days until next milestone

Study Start

First participant enrolled

February 23, 2026

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2029

Last Updated

May 18, 2026

Status Verified

February 1, 2026

Enrollment Period

2.9 years

First QC Date

February 3, 2026

Last Update Submit

May 14, 2026

Conditions

Cardiac Surgery Associated - Acute Kidney InjuryCritical Illness

Keywords

Acute kidney injuryBiomarkerPoor outcomeAKI occurrencePrognostic valueCardiac Surgery Associated - Acute Kidney Injury

Outcome Measures

Primary Outcomes (1)

  • AKI occurrence within 7 days

    AKI was defined based on the Kidney Disease Improving Global Outcomes (KDIGO) criteria.

    7 days

Secondary Outcomes (10)

  • Moderate and severe AKI occurrence within 7 days

    7 days

  • AKI occurrence within 48 hours

    48 hours

  • AKI occurrence within 3 days

    3 days

  • Major adverse kidney events

    Perioperative

  • Receipt of renal replacement treatment

    Perioperative

  • +5 more secondary outcomes

Interventions

Standard care "bundle"OTHER

The management for AKI patients were performed by implementing a standard care "bundle" suggested by the Kidney Disease Improving Global Outcome (KDIGO) guideline.

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All high-risk AKI patients who underwent cardiac surgery at Zhongshan Hospital Affiliated to Fudan University.CSA-AKI is the second most common cause of AKI in the intensive care setting (after sepsis) and is independently associated with increased morbidity and mortality. The incidence of cardiac surgery-associated AKI (CSA-AKI) varies from 5% to 42%.

You may qualify if:

  • The AKI risk factors were as follows:
  • age \>70 years;
  • \< estimated glomerular filtration rate (eGFR) \<60 mL·min-1·1.73 m-2;
  • diabetes mellitus, proteinuria;
  • a history of congestive heart failure within the previous year;
  • a left ventricular ejection fraction of 40% or lower;
  • prior cardiac surgery;
  • combined coronary artery bypass/valve procedure;
  • urgent procedure;
  • preoperative intra-aortic balloon pump.

You may not qualify if:

  • pre-existing chronic kidney disease (preoperative estimated glomerular filtration rate \[eGFR\] \< 30 mL/min/1.73 m2);
  • previous RRT before cardiac surgery;
  • present AKI at screening;
  • a history of kidney transplant or other kidney diseases;
  • known pregnancy;
  • multiple operation during the hospital stay;
  • being in a moribund state (with an anticipated likelihood of death within 48 hours).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Zhongshan hospital, Fudan university

Shanghai, Shanghai Municipality, 200030, China

NOT YET RECRUITING

Zhongshan hospital

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

2-5ml blood and urine samples for biomarker analysis will be collected before surgery and within 6-12 hours after surgery. Plasma (EDTA), serum, and urine supernatants were frozen within 2 h of sample collection, stored at -80#, and thawed immediately before analysis.

MeSH Terms

Conditions

Critical IllnessAcute Kidney Injury

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Zhe Luo, MD

    Fudan University

    STUDY DIRECTOR

Central Study Contacts

Guo wei Tu, MD

CONTACT

86-021-64041990tu.guowei@zs-hospital.sh.cn

Ying Su, MD

CONTACT

+86 021 64041990su.ying@zs-hospital.sh.cn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Scientific Secretary for Cardiac Intensive Care Center

Study Record Dates

First Submitted

February 3, 2026

First Posted

February 18, 2026

Study Start

February 23, 2026

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

May 31, 2029

Last Updated

May 18, 2026

Record last verified: 2026-02

Locations

CN(2)