Trials Sponsors Conditions Drugs Pricing

Conditions

Cardiac Surgery Associated - Acute Kidney Injury Critical Illness

Keywords

Acute kidney injuryBiomarkerMetabolic characteristicsPoor outcomePrognostic valueCardiac surgery associated AKI

Outcome Measures

Primary Outcomes (1)

Rate of AKI occurrence within 3 days
AKI was defined based on the Kidney Disease Improving Global Outcomes (KDIGO) criteria.
3 days

Secondary Outcomes (10)

Rate of AKI within 48 hours
48 hours
Rate of AKI within 7 days
7 days
Rate of Severe AKI occurrence within 7 days
7 days
Rate of major adverse kidney events
365 days
Rate of receipt of renal replacement treatment
90 days
+5 more secondary outcomes

Study Arms (2)

Model development cohort

The model development cohort is planned to select patients from the sample bank at high risk of AKI who underwent cardiac surgery. Pick those patients who developed AKI and who did not develop AKI for 1:1 matching, with 30 cases in each group. Through methods such as logistic regression, the combinations of medical history, laboratory data and specimen test results and multi-omics factors that can be used to predict and warn of the main research endpoints at an early stage were preliminarily screened.A predictive model will be established and its non-inferiority over traditional markers will be tested.

Other: Standard care "bundle"

Model validation cohort

The validation cohort will be established: all high-risk populations who underwent cardiac surgery from 2026-1 to 2029-12 will be prospectively included. Blood and urine samples will be collected before and within 24 hours after the operation. The target metabolites will be detected in blood and urine samples by ELISA or mass spectrometry, and correlation analysis will be conducted with the research endpoint to verify the stability and reliability of the model.

Other: Standard care "bundle"

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.

Model development cohortModel validation cohort

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 90 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodProbability Sample

Study Population

The incidence of cardiac surgery-associated AKI (CSA-AKI) varies from 5% to 42%. 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. Patients was diagnosed AKI by KDIGO criteria.

You may qualify if:

All patients is going to undergo non-emergency cardiac surgeries, including cardiopulmonary bypass or non-cardiopulmonary bypass surgeries;

Sponsors & Collaborators

Shanghai Zhongshan Hospital
Otherlead

Study Sites (1)

180 Fenglin Road

Shanghai, 200032, China

Biospecimen

Retention: SAMPLES WITHOUT DNA

2-5ml blood and urine samples for biomarker analysis will be collected before surgery and 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, Professor
Zhongshan hospital, Fudan university,Shanghai, China
STUDY DIRECTOR

Central Study Contacts

Guo wei Tu, MD

CONTACT

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

Ying Su, MD

CONTACT

+86 021 64041990

Study Design

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

Study Record Dates

First Submitted

March 23, 2026

First Posted

April 13, 2026

Study Start

April 23, 2026

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Primary Completion

Prognostic Value of Metabolic Characteristics in High-Risk Populations for Acute Kidney Injury After Cardiac Surgery

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (10)

Study Arms (2)

Model development cohort

Model validation cohort

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Biospecimen

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (10)

Study Arms (2)

Model development cohort

Model validation cohort

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Biospecimen

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations