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

NCT ID: NCT06710353

Last Updated: 2025-04-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

190 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-09

Study Completion Date

2027-12-31

Brief Summary

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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

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Conditions

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Acute Kidney Injury Pediatric Cardiac Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Albumin group

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

Group Type EXPERIMENTAL

No interventions assigned to this group

Control group

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

Group Type PLACEBO_COMPARATOR

No interventions assigned to this group

Interventions

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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)

Intervention Type DRUG

Crystalloid solutions

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

Intervention Type DRUG

Eligibility Criteria

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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
Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ji-Hyun Lee

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Seoul National University Hospital

Seoul, Seoul, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Ji-Hyun Lee

Role: CONTACT

82-2-2072-3661

Facility Contacts

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Ji-hyun Lee, MD, PhD

Role: primary

82 10 7665 8848

Other Identifiers

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H2410-094-1578

Identifier Type: -

Identifier Source: org_study_id

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