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

Seoul National University

Status: Enrolling

Conditions: Pediatric Cardiac Surgery; Acute Kidney Injury

Treatments: Drug: Crystalloid solutions; Drug: Albumin solution

Study type: Interventional

Funder types: Other

Identifiers

NCT06710353

H2410-094-1578

Details and patient eligibility

About

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.

Enrollment: 190 estimated patients

Sex: All

Ages: Under 7 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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190 participants in 2 patient groups, including a placebo group

Albumin group

Experimental group

Description:

A 20% albumin solution is administered over a period of one hour, starting at the time of anesthesia induction.

Control group

Placebo Comparator group

Description:

The same volume of crystalloid solution as the administered albumin is infused.