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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
Interventions
Drug: Albumin solution
Drug: Crystalloid solutions
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

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
Arm && Interventions
GroupInterventionDescription
Albumin groupAlbumin solutionA 20% albumin solution is administered over a period of one hour, starting at the time of anesthesia induction.
Control groupCrystalloid solutionsThe same volume of crystalloid solution as the administered albumin is infused.
Primary Outcome Measures
NameTimeMethod
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

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Seoul National University Hospital

🇰🇷

Seoul, Korea, Republic of

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