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

Not Applicable

Recruiting

• Conditions: Acute Kidney Injury; Pediatric Cardiac Surgery

• Registration Number: NCT06710353
• Lead Sponsor: Seoul National University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-11-25
• Study First Submitted QC: 2024-11-25
• Study First Posted: 2024-11-29
• Study Start: 2025-01-09
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-17
• Last Update Posted: 2025-04-23
• Primary Completion: 2027-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 190

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of