The Effect of Preoperative Albumin Administration on Postoperative Acute Kidney Injury in Pediatric Patients With Hypoalbuminemia Undergoing Cardiac Surgery
1 other identifier
interventional
190
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2025
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 25, 2024
CompletedFirst Posted
Study publicly available on registry
November 29, 2024
CompletedStudy Start
First participant enrolled
January 9, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
April 23, 2025
April 1, 2025
3 years
November 25, 2024
April 17, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
incidence of acute kidney injury (AKI)
The difference in the incidence of acute kidney injury (AKI) between groups, as measured by the KDIGO criteria
assessed up to postoperative day 7
Study Arms (2)
Albumin group
EXPERIMENTALA 20% albumin solution is administered over a period of one hour, starting at the time of anesthesia induction.
Control group
PLACEBO COMPARATORThe same volume of crystalloid solution as the administered albumin is infused.
Interventions
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)
The same volume of crystalloid solution as the administered albumin is infused.
Eligibility Criteria
You may qualify if:
- Pediatric patients under 7 years of age undergoing cardiac surgery with cardiopulmonary bypass
- Preoperative serum albumin level of 4.0 g/dL or lower
You may not qualify if:
- abnormal preoperative creatinine level
- history of dialysis
- liver dysfunction
- diabetes
- history of hypersensitivity to albumin
- coagulation disorders
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Hospital
Seoul, Seoul, 03080, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
November 25, 2024
First Posted
November 29, 2024
Study Start
January 9, 2025
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
December 31, 2027
Last Updated
April 23, 2025
Record last verified: 2025-04