Skip to main content
MedPathMedPath Home
Clinical Trials/NCT06710353
NCT06710353
Recruiting
Not Applicable

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

Seoul National University Hospital1 site in 1 country190 target enrollmentJanuary 9, 2025
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
ConditionsAcute Kidney InjuryPediatric Cardiac Surgery
DrugsAlbumin solutionCrystalloid solutions

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Acute Kidney Injury
Sponsor
Seoul National University Hospital
Enrollment
190
Locations
1
Primary Endpoint
incidence of acute kidney injury (AKI)
Status
Recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 9, 2025
End Date
December 31, 2027
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ji-Hyun Lee

Associate Professor

Seoul National University Hospital

Eligibility Criteria

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
  • •history of hypersensitivity to albumin
  • •coagulation disorders

Outcomes

Primary Outcomes

incidence of acute kidney injury (AKI)

Time Frame: assessed up to postoperative day 7

The difference in the incidence of acute kidney injury (AKI) between groups, as measured by the KDIGO criteria

Study Sites (1)

Loading locations...

Similar Trials

Recruiting
Not Applicable
Impact of Preoperative Serum Albumin Level on Postoperative Outcomes in Chinese HCC Patients Treated With SurgeryHepatocellular Carcinoma
NCT05970159Shanghai Zhongshan Hospital480
Completed
Phase 4
SUbstition of PERioperative Albumin Deficiency DisordersHypoalbuminemia
NCT03167645Technical University of Munich600
Completed
Phase 4
Efficacy of Albumin for Acute Encephalopathy in Patients With CirrhosisHepatic Encephalopathy
NCT00886925Hospital Universitari Vall d'Hebron Research Institute56
Completed
Phase 4
Post Transjugular Intrahepatic Portosystemic Shunt (Tips) Albumine Infusion to Prevent Hepatic EncephalopathyHepatic Encephalopathy
NCT01559519University of Roma La Sapienza20
Terminated
Phase 2
Study of Albumin to Reduce Inflammation Following SurgerySystemic Inflammatory Response SyndromeCardiopulmonary Bypass
NCT00773110Imperial College London232