Acute Kidney InjuryNCT04962412
Predicting Poor Outcomes of Cardiac Surgery-Associated Acute Kidney Injury Using Novel Biomarkers
An observational study of Acute Kidney Injury and Critical Illness, run by Guowei Tu at 1 site in China.
Trial summary
The aim of this study was to identify and validate novel biomarkers including functional tests for detecting AKI, AKI progression and other poor outcomes. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Acute Kidney Injury, Critical Illness
- How many people
- 3,152 participants
- Where
- 1 siteChina
- Study dates
- 15 Jul 2021to 31 May 2025
- How long will I take part?
- 365 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- Patients undergoing cardiac surgery were prospectively screened, and those who developed AKI within 48 hours post-surgery were included in the study.
Who cannot join
- History of End Stage Renal Disease or on Dialysis;
- prior kidney transplantation;
- patients with a DNR order;
- patients without written informed consent;
- pregnancy;
- moribund patients with expected death within 24 h or whose survival to 28 days was unlikely due to an uncontrollable comorbidity (i.e., end-stage liver or heart disease, untreatable malignancy)
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study was to identify and validate novel biomarkers including functional tests for detecting AKI, AKI progression and other poor outcomes.
Read the detailed description
Cardiac surgery-associated acute kidney injury (CSA-AKI) is the second most common type of AKI after septic AKI and is associated with increased mortality and morbidity. The progression of AKI with multiple organ failure can result in poor outcomes. Several novel biomarkers for earlier detection of AKI, discrimination of etiologies, and prediction of outcomes were developed. However, the availability of these novel biomarkers may be limited by its expense or reimbursement issues in different countries. In present study, we conduct a large cohort to identify and validate novel biomarkers including functional tests for detecting AKI, AKI progression and other poor outcomes.
- Conditions
- Acute Kidney Injury, Critical Illness
- Being tested
- Standard care "bundle"
- Keywords
- Acute kidney injury, Biomarker, AKI progression, Poor outcome, Furosemide Stress Test
- Medical subject headings
- Acute Kidney Injury, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
AKI progression
worsening of KDIGO stage within 1 week (progressing from stage 1 to either stage 2 or stage 3, or from stage 2 to stage 3).
Patients diagnosed with progressive or persisting stage 3 AKI (stage 3 AKI for >3 consecutive days) were classified as having AKI progression.
If patients who presented with stage 3 AKI but not requiring RRT subsequently required dialysis or developing persist severe AKI or death within 7 days, this was considered progression.
Measured: 7 days
Secondary outcomes (10)
Mortality
Mortality at 30 days, 90 days and 365 days
Measured: 365 days
Receipt of renal replacement treatment
Patients received renal replacement treatment during hospital stay
Measured: 365 days
Major adverse kidney events
MAKE was defined as the composite of≥25% loss in estimated glomerular filtration rate (eGFR), dialysis, or death. Estimated GFR was calculated from serum creatinine using the MDRD equation
Measured: 365 days
Persistent AKI
Persistent AKI is characterized by the continuance of AKI by serum creatinine or urine output criteria (as defined by KDIGO) beyond 48h from AKI onset.
Measured: 90 days
Persist severe AKI
Persistent severe AKI was defined as follows: Patients with stage 3 AKI at enrollment required a persistence of 72 hours or more to meet the end point.
Patients enrolled at stage 2 AKI required a progression to stage 3 within 48 hours and a persistence at stage 3 for 72 consecutive hours to be considered end point positive.
Additionally, patients with severe AKI who failed to achieve 72 hours due to death or the initiation of RRT were considered end point positive.
Measured: 90 days
Length of stay in the ICU
Length of stay in the ICU
Measured: 90 days
Length of stay in the hospital
Length of stay in the hospital
Measured: 90 days
AKI progression to stage 3
worsening of KDIGO stage to stage 3 within 1 week (progressing from stage 1 or stage 2 to stage 3).
Measured: 7 days
AKI occurrence at 3 days
AKI was defined based on the Kidney Disease Improving Global Outcomes (KDIGO) criteria.
Measured: 3 days
AKI occurrence at 7 days
AKI was defined based on the Kidney Disease Improving Global Outcomes (KDIGO) criteria.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2021
- Study start15 Jul 2021
- Primary completion31 Dec 2024
- Study completion31 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,152 participants (actual)
- Target duration
- 365 Days
Sponsor and investigators
- Lead sponsor
- Guowei Tu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Guowei Tu, Shanghai Zhongshan Hospital
- Investigators
- Zhe Luo, Professor, Study director, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04962412
- Sponsor's protocol ID
- B2021-390R
- Status last verified
- May 2025
- First submitted
- 4 Jul 2021
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Su Y, Liu WJ, Zhao YF, Zhang YJ, Qiu Y, Lu ZH, Wang P, Lin S, Tu GW, Luo Z. Modified furosemide responsiveness index and biomarkers for AKI progression and prognosis: a prospective observational study. Ann Intensive Care. 2024 Oct 8;14(1):156. doi: 10.1186/s13613-024-01387-y.
PubMed 39379672Su Y, Wang P, Hu Y, Liu WJ, Zhang YJ, Chen JQ, Deng YZ, Lin S, Qiu Y, Li JK, Chen C, Tu GW, Luo Z. AKI-Pro score for predicting progression to severe acute kidney injury or death in patients with early acute kidney injury after cardiac surgery. J Transl Med. 2024 Jun 16;22(1):571. doi: 10.1186/s12967-024-05279-4.
PubMed 38879493
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting Poor Outcomes of Cardiac Surgery-Associated Acute Kidney Injury Using Novel Biomarkers
- ClinicalTrials.gov ID
- NCT04962412
- Acronym / sponsor ID
- B2021-390R
- Conditions
- Acute Kidney Injury, Critical Illness
- Keywords
- Acute kidney injury, Biomarker, AKI progression, Poor outcome, Furosemide Stress Test
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,152 participants (actual)
- Lead sponsor
- Guowei TuUniversity, hospital or other
- Study start
- 15 Jul 2021 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 May 2025 (actual)
- First posted
- 15 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study was to identify and validate novel biomarkers including functional tests for detecting AKI, AKI progression and other poor outcomes.
Detailed description
Cardiac surgery-associated acute kidney injury (CSA-AKI) is the second most common type of AKI after septic AKI and is associated with increased mortality and morbidity. The progression of AKI with multiple organ failure can result in poor outcomes. Several novel biomarkers for earlier detection of AKI, discrimination of etiologies, and prediction of outcomes were developed. However, the availability of these novel biomarkers may be limited by its expense or reimbursement issues in different countries. In present study, we conduct a large cohort to identify and validate novel biomarkers including functional tests for detecting AKI, AKI progression and other poor outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 365 Days
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Patients undergoing cardiac surgery were prospectively screened, and those who developed AKI within 48 hours post-surgery were included in the study.
Key exclusion criteria (6 listed)
- History of End Stage Renal Disease or on Dialysis;
- prior kidney transplantation;
- patients with a DNR order;
- patients without written informed consent;
- pregnancy;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard care "bundle"The management for AKI patients were performed by implementing a standard care "bundle" suggested by the Kidney Disease Improving Global Outcome (KDIGO) guideline. | Other | – |
Primary outcome
AKI progression
Time frame: 7 days
worsening of KDIGO stage within 1 week (progressing from stage 1 to either stage 2 or stage 3, or from stage 2 to stage 3). Patients diagnosed with progressive or persisting stage 3 AKI (stage 3 AKI for >3 consecutive days) were classified as having AKI progression. If patients who presented with stage 3 AKI but not requiring RRT subsequently required dialysis or developing persist severe AKI or death within 7 days, this was considered progression.
10 secondary outcomes
Mortality
Time frame: 365 days
Receipt of renal replacement treatment
Time frame: 365 days
Major adverse kidney events
Time frame: 365 days
Persistent AKI
Time frame: 90 days
Persist severe AKI
Time frame: 90 days
Length of stay in the ICU
Time frame: 90 days
Length of stay in the hospital
Time frame: 90 days
AKI progression to stage 3
Time frame: 7 days
AKI occurrence at 3 days
Time frame: 3 days
AKI occurrence at 7 days
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Derived from this study: PubMed 39379672Su Y, Liu WJ, Zhao YF, Zhang YJ, Qiu Y, Lu ZH, Wang P, Lin S, Tu GW, Luo Z. Modified furosemide responsiveness index and biomarkers for AKI progression and prognosis: a prospective observational study. Ann Intensive Care. 2024 Oct 8;14(1):156. doi: 10.1186/s13613-024-01387-y.
- Derived from this study: PubMed 38879493Su Y, Wang P, Hu Y, Liu WJ, Zhang YJ, Chen JQ, Deng YZ, Lin S, Qiu Y, Li JK, Chen C, Tu GW, Luo Z. AKI-Pro score for predicting progression to severe acute kidney injury or death in patients with early acute kidney injury after cardiac surgery. J Transl Med. 2024 Jun 16;22(1):571. doi: 10.1186/s12967-024-05279-4.
- Individual participant dataSharing planned: Undecided
Related trials for Acute Kidney Injury
Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
Not yet recruiting
Early Biomarker Kidney Injury Assessment After Acumen Directed Fluid Management in Cardiac Surgery
Renal Injury, Acute Kidney Injury
Recruiting
Acute Kidney Injury and Ultra-endurance Running
AKI (Acute Kidney Injury) Due to Trauma
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
Not yet recruitingObservational study
Diastolic Shock Index for Predicting Hemodynamic Instability During Continuous Renal Replacement Therapy
Acute Kidney Injury, Hypotension (MeSH: D007022)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhe Luo, Professor study director
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury and Critical Illness, run by Guowei Tu at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AKI progression (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04962412, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.