Patients Undergoing Valvular Heart SurgeryNCT06647771
Relationship Between Postoperative Tempeartive and Acute Kidney Injury
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 identify body temperature trajectory classes based on core temperature changes during the first 12 hours post-surgery and to explore their relationship with postoperative acute kidney injury in patients undergoing valvular heart surgery. 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
- 3,274 participants
- Where
- 1 siteSouth Korea
- Study dates
- 12 Aug 2024to 11 Aug 2026
- 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 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 between January 2016 and July 2023 at Severance Cardiovascular Hospital of Yonsei University Health System
Who cannot join
- Patients who underwent the same surgery within 30 days,
- Patients with less than two temperature measurements within 12 hours after surgery, - Patients with missing creatinine test values before and within seven days after surgery,
- Patients who died during surgery
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
Seoul
About this study
Official title: Relationship Between First 12-h Body Temperature and Acute Kidney Injury After Valvular Heart Surgery
The investigators aimed to identify body temperature trajectory classes based on core temperature changes during the first 12 hours post-surgery and to explore their relationship with postoperative acute kidney injury in patients undergoing valvular heart surgery.
What is being measured
The primary outcome is the main question the study is designed to answer.
acute kidney injury ≥ stage 2 according to the KDIGO criteria
According to the KDIGO criteria, postoperative acute kidney injury of stage 2 or higher was defined as a 100% increase in creatinine within the first seven days after surgery. The association between stage 2-3 acute kidney injury and postoperative body temperature trajectory classes was investigated.
Measured: seven days after valvular heart surgery
Secondary outcomes (2)
non-recovery from acute kidney injury within 48
The association between postoperative body temperature trajectory classes and non-recovery from acute kidney injury was investigated at two time points: within 48 hours
Measured: 72 hours after the onset of acute kidney injury
non-recovery from acute kidney injury within 72 hours
The association between postoperative body temperature trajectory classes and non-recovery from acute kidney injury was investigated at two time points: within 72 hours.
Measured: 72 hours after the onset of acute kidney injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2024
- Study start12 Aug 2024
- Primary completion11 Aug 2026 (estimated)
- Study completion11 Aug 2026 (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
- Other
- Time perspective
- Retrospective
- Enrolment
- 3,274 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
- NCT06647771
- Sponsor's protocol ID
- 4-2024-0771
- Status last verified
- Oct 2024
- First submitted
- 13 Oct 2024
- Last updated
- 18 Oct 2024
- 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 18 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between First 12-h Body Temperature and Acute Kidney Injury After Valvular Heart Surgery
- ClinicalTrials.gov ID
- NCT06647771
- Acronym / sponsor ID
- 4-2024-0771
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,274 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 12 Aug 2024 (actual)
- Primary completion
- 11 Aug 2026 (estimated)
- Study completion
- 11 Aug 2026 (estimated)
- First posted
- 18 Oct 2024 (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 identify body temperature trajectory classes based on core temperature changes during the first 12 hours post-surgery and to explore their relationship with postoperative acute kidney injury in patients undergoing valvular heart surgery.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
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 between January 2016 and July 2023 at Severance Cardiovascular Hospital of Yonsei University Health System
Key exclusion criteria (3 listed)
- Patients who underwent the same surgery within 30 days,
- Patients with less than two temperature measurements within 12 hours after surgery, - Patients with missing creatinine test values before and within seven days after surgery,
- Patients who died during surgery
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 injury ≥ stage 2 according to the KDIGO criteria
Time frame: seven days after valvular heart surgery
According to the KDIGO criteria, postoperative acute kidney injury of stage 2 or higher was defined as a 100% increase in creatinine within the first seven days after surgery. The association between stage 2-3 acute kidney injury and postoperative body temperature trajectory classes was investigated.
2 secondary outcomes
non-recovery from acute kidney injury within 48
Time frame: 72 hours after the onset of acute kidney injury
non-recovery from acute kidney injury within 72 hours
Time frame: 72 hours after the onset of acute kidney injury
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2024.
- Individual participant dataSharing planned: No
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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 3 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: status not confirmed, as of the sponsor's last update on 18 Oct 2024. 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?
Results are not available in the source record.
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 injury ≥ stage 2 according to the KDIGO criteria (time frame: seven days after valvular heart surgery). 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 18 Oct 2024.