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NCT Number: NCT06710353

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

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.

Recruiting

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Key information

Conditions

Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pediatric Cardiac Surgery Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

Up to 7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, 03080, South Korea

Location status: Recruiting

Location contact

Ji-hyun Lee, MD, PhD

CONTACT

[email protected]

82 10 7665 8848

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Albumin solution

Drug

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)

Crystalloid solutions

Drug

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

Primary outcomes

  1. 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 contacts

Contact information is provided by the study sponsor or research team.

Ji-Hyun Lee

CONTACT

[email protected]

82-2-2072-3661

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Nov 29, 2024
Registry last updated
Apr 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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