Acute Kidney InjuryNCT06710353
The Effect of Preoperative Albumin Administration on Postoperative Acute Kidney Injury in Pediatric Patients With Hypoalbuminemia Undergoing Cardiac Surgery
A study testing Albumin solution and Crystalloid solutions in people with Acute Kidney Injury and Pediatric Cardiac Surgery, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The study aims to evaluate whether preoperative albumin supplementation in pediatric patients with hypoalbuminemia undergoing cardiac surgery can reduce inflammatory responses and prevent acute kidney injury (AKI) following cardiopulmonary bypass. Read more about this study
- Who is it for?
- Ages Up to 7 years
- Conditions the study is for
- Acute Kidney Injury, Pediatric Cardiac Surgery
- What is being tested?
- Albumin solution and Crystalloid solutions
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 190 participants
- Where
- 1 siteSouth Korea
- Study dates
- 9 Jan 2025to 31 Dec 2027
- Phase
- Interventional
- 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 Up to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Pediatric patients under 7 years of age undergoing cardiac surgery with cardiopulmonary bypass
- Preoperative serum albumin level of 4.0 g/dL or lower
Who cannot join
- abnormal preoperative creatinine level
- history of dialysis
- liver dysfunction
- diabetes
- history of hypersensitivity to albumin
- coagulation disorders
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul, Seoul, 03080
Ji-hyun Lee, MD, PhD, 82 10 7665 8848, muslab6@snu.ac.kr
About this study
Official title: The Effect of Preoperative Albumin Administration on Postoperative Acute Kidney Injury in Pediatric Patients With Hypoalbuminemia Undergoing Cardiac Surgery: A Prospective Randomized Clinical Trial
The study aims to evaluate whether preoperative albumin supplementation in pediatric patients with hypoalbuminemia undergoing cardiac surgery can reduce inflammatory responses and prevent acute kidney injury (AKI) following cardiopulmonary bypass.
- Conditions
- Acute Kidney Injury, Pediatric Cardiac Surgery
- Being tested
- Albumin solution, Crystalloid solutions
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Albumin solutionDrug
A 20% albumin solution is administered over one hour starting from the induction of anesthesia, using the following formula:
(4.0-preoperative serum albumin (g/dL))×plasma volume (kg×0.65-0.8 dL)
Crystalloid solutionsDrug
The same volume of crystalloid solution as the administered albumin is infused.
| Study group | Role | What they receive |
|---|---|---|
| Albumin group | Experimental | A 20% albumin solution is administered over a period of one hour, starting at the time of anesthesia induction. |
| Control group | Placebo comparator | The same volume of crystalloid solution as the administered albumin is infused. |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of acute kidney injury (AKI)
The difference in the incidence of acute kidney injury (AKI) between groups, as measured by the KDIGO criteria
Measured: assessed up to postoperative day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2024
- Study start9 Jan 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ji-Hyun Lee, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06710353
- Sponsor's protocol ID
- H2410-094-1578
- Status last verified
- Apr 2025
- First submitted
- 25 Nov 2024
- Last updated
- 23 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Preoperative Albumin Administration on Postoperative Acute Kidney Injury in Pediatric Patients With Hypoalbuminemia Undergoing Cardiac Surgery: A Prospective Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06710353
- Acronym / sponsor ID
- H2410-094-1578
- Conditions
- Acute Kidney Injury, Pediatric Cardiac Surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 9 Jan 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 29 Nov 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 study aims to evaluate whether preoperative albumin supplementation in pediatric patients with hypoalbuminemia undergoing cardiac surgery can reduce inflammatory responses and prevent acute kidney injury (AKI) following cardiopulmonary bypass.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Albumin group | Experimental | –A 20% albumin solution is administered over a period of one hour, starting at the time of anesthesia induction. |
| Control group | Placebo comparator | –The same volume of crystalloid solution as the administered albumin is infused. |
Who may qualify
- Ages
- Up to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Pediatric patients under 7 years of age undergoing cardiac surgery with cardiopulmonary bypass
- Preoperative serum albumin level of 4.0 g/dL or lower
Key exclusion criteria (6 listed)
- abnormal preoperative creatinine level
- history of dialysis
- liver dysfunction
- diabetes
- history of hypersensitivity to albumin
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 |
|---|---|---|
| Albumin solutionA 20% albumin solution is administered over one hour starting from the induction of anesthesia, using the following formula: (4.0-preoperative serum albumin (g/dL))×plasma volume (kg×0.65-0.8 dL) | Drug | – |
| Crystalloid solutionsThe same volume of crystalloid solution as the administered albumin is infused. | Drug | – |
Primary outcome
incidence of acute kidney injury (AKI)
Time frame: assessed up to postoperative day 7
The difference in the incidence of acute kidney injury (AKI) between groups, as measured by the KDIGO criteria
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 23 Apr 2025.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Albumin solution and Crystalloid solutions in people with Acute Kidney Injury and Pediatric Cardiac Surgery, run by Seoul National University Hospital 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 2 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: looking for participants now, as of the sponsor's last update on 23 Apr 2025. 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. Some participants in this study may receive a placebo. 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?
Contact Ji-Hyun Lee (82-2-2072-3661, muslab6@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of acute kidney injury (AKI) (time frame: assessed up to postoperative day 7). 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 23 Apr 2025.