Patients Undergoing Valvular Heart SurgeryNCT07907198
Associations of Postoperative Hemoglobin With AKI-AKD Trajectories
An observational study of Patients Undergoing Valvular Heart Surgery, run by Yonsei University at 1 site in South Korea.
Trial summary
The investigators aimed to investigate the association of postoperative hemoglobin levels with acute kidney injury and acute kidney disease after valvular heart surgery, with a focus on acute kideny disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients Undergoing Valvular Heart Surgery
- How many people
- 4,230 participants
- Where
- 1 siteSouth Korea
- Study dates
- 18 Sep 2026to 17 Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: tertiary care hospital
Who may be able to join
- Patients who underwent valvular heart surgery, including concomitant coronary artery bypass grafting, aortic procedures, or other cardiac procedures, between January 2013 and December 2023 at Severance Cardiovascular Hospital of Yonsei University Health System
Who cannot join
- Patients who underwent congenital heart surgery or presenting with acute coronary syndrome, including ST-elevation myocardial infarction, were excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Temporal Associations of Postoperative Hemoglobin With AKI-AKD Trajectories After Valvular Heart Surgery
The investigators aimed to investigate the association of postoperative hemoglobin levels with acute kidney injury and acute kidney disease after valvular heart surgery, with a focus on acute kideny disease.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Valvular heart surgery patient | Patients aged 18 years or older who underwent valvular heart surgery with cardiopulmonary bypass between January 2013 and December 2023, whose postoperative hemoglobin levels and renal outcomes were assessed retrospectively. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute kidney disease
Acute kidney disease (AKD) was defined according to the KDIGO criteria as kidney dysfunction occurring or persisting between postoperative days 8 and 90, meeting at least one of the following criteria: a ≥50% increase in serum creatinine (sCr) from baseline, an estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m² or a ≥35% decrease in eGFR from baseline, or receipt of kidney replacement therapy.
Measured: Bewteen postoperative days 8 and 90
Secondary outcomes (1)
Acute kidney injury
AKI was defined according to the KDIGO criteria as an increase in sCr of ≥0.3 mg/dL within 48 h or ≥50% within 7 days after surgery.
Measured: within postoperative days 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2026
- Study start18 Sep 2026
- Primary completion17 Sep 2027 (estimated)
- Study completion17 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients Undergoing Valvular Heart SurgeryStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 4,230 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07907198
- Sponsor's protocol ID
- 4-2026-1224
- Status last verified
- Oct 2026
- First submitted
- 26 Oct 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Temporal Associations of Postoperative Hemoglobin With AKI-AKD Trajectories After Valvular Heart Surgery
- ClinicalTrials.gov ID
- NCT07907198
- Acronym / sponsor ID
- 4-2026-1224
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 4,230 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 18 Sep 2026 (actual)
- Primary completion
- 17 Sep 2027 (estimated)
- Study completion
- 17 Sep 2027 (estimated)
- First posted
- 30 Oct 2026 (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 investigators aimed to investigate the association of postoperative hemoglobin levels with acute kidney injury and acute kidney disease after valvular heart surgery, with a focus on acute kideny disease.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Valvular heart surgery patient | – | –Patients aged 18 years or older who underwent valvular heart surgery with cardiopulmonary bypass between January 2013 and December 2023, whose postoperative hemoglobin levels and renal outcomes were assessed retrospectively. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- tertiary care hospital
Key inclusion criteria (1 listed)
- Patients who underwent valvular heart surgery, including concomitant coronary artery bypass grafting, aortic procedures, or other cardiac procedures, between January 2013 and December 2023 at Severance Cardiovascular Hospital of Yonsei University Health System
Key exclusion criteria (1 listed)
- Patients who underwent congenital heart surgery or presenting with acute coronary syndrome, including ST-elevation myocardial infarction, were excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Acute kidney disease
Time frame: Bewteen postoperative days 8 and 90
Acute kidney disease (AKD) was defined according to the KDIGO criteria as kidney dysfunction occurring or persisting between postoperative days 8 and 90, meeting at least one of the following criteria: a ≥50% increase in serum creatinine (sCr) from baseline, an estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m² or a ≥35% decrease in eGFR from baseline, or receipt of kidney replacement therapy.
1 secondary outcome
Acute kidney injury
Time frame: within postoperative days 7
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Patients Undergoing Valvular Heart Surgery
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Comparing Measurements of the Aortic Valve Taken During Surgery With Those Obtained Before Surgery Using Computed Tomography Scans, in Patients Undergoing Surgical Aortic Valve Replacement
Valvular Heart Disease
Active, not recruiting
Quantitative Flow Ratio (QFR) Guided Coronary Artery Bypass Grafting for Patients Undergoing Primary Valve Surgery With Concomitant Coronary Artery Disease
Primary Valvular Heart Disease With Comorbid Coronary Artery Disease, Planned to Undergo Elective On-pump Valve Surgery Due to Primary Mitral and/or Aortic Valvular Heart Disease
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Patients Undergoing Valvular Heart Surgery, run by Yonsei University at 1 site in South Korea.
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 1 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: under way, not looking for participants, as of the sponsor's last update on 30 Oct 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 South Korea. 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?
This study is still under way. Results are not available in the source record yet.
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?
Acute kidney disease (time frame: Bewteen postoperative days 8 and 90). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Oct 2026.