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The Effect of Preoperative Albumin Administration on Postoperative Acute Kidney Injury in Pediatric Patients With Hypoalbuminemia Undergoing Cardiac Surgery

The Effect of Preoperative Albumin Administration on Postoperative Acute Kidney Injury in Pediatric Patients With Hypoalbuminemia Undergoing Cardiac Surgery: A Prospective Randomized Clinical Trial

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06710353
Enrollment
190
Registered
2024-11-29
Start date
2025-01-09
Completion date
2027-12-31
Last updated
2025-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Kidney Injury, Pediatric Cardiac Surgery

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.

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.

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
No minimum to 7 Years
Healthy volunteers
No

Inclusion criteria

* Pediatric patients under 7 years of age undergoing cardiac surgery with cardiopulmonary bypass * Preoperative serum albumin level of 4.0 g/dL or lower

Exclusion criteria

* abnormal preoperative creatinine level * history of dialysis * liver dysfunction * diabetes * history of hypersensitivity to albumin * coagulation disorders

Design outcomes

Primary

MeasureTime frameDescription
incidence of acute kidney injury (AKI)assessed up to postoperative day 7The difference in the incidence of acute kidney injury (AKI) between groups, as measured by the KDIGO criteria

Countries

South Korea

Contacts

Primary ContactJi-Hyun Lee
muslab6@snu.ac.kr82-2-2072-3661

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026