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

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 Overview

• Status: Recruiting
• Conditions: Acute Kidney Injury; Pediatric Cardiac Surgery
• Intervention / Treatment: Drug: Albumin solution; Drug: Crystalloid solutions

• Study Type: Interventional
• Enrollment (Estimated): 190
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ji-Hyun Lee; Phone Number: 82-2-2072-3661; Email: muslab6@snu.ac.kr

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03080
    • Recruiting
    • Seoul National University Hospital
    • Contact: Ji-hyun Lee, MD, PhD; Phone Number: 82 10 7665 8848; Email: muslab6@snu.ac.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Albumin group; A 20% albumin solution is administered over a period of one hour, starting at the time of anesthesia induction.	Drug: Albumin solution; 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)
Placebo Comparator: Control group; The same volume of crystalloid solution as the administered albumin is infused.	Drug: Crystalloid solutions; The same volume of crystalloid solution as the administered albumin is infused.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: November 25, 2024
• First Submitted That Met QC Criteria: November 25, 2024
• First Posted (Actual): November 29, 2024

Study Record Updates

• Last Update Posted (Actual): April 23, 2025
• Last Update Submitted That Met QC Criteria: April 17, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Hematologic Diseases; Renal Insufficiency; Blood Protein Disorders; Hypoproteinemia; Acute Kidney Injury; Wounds and Injuries; Hypoalbuminemia; Pharmaceutical Solutions
• Other Study ID Numbers: H2410-094-1578

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No