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

ConditionsAcute Kidney InjuryPediatric Cardiac Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 7
SponsorSeoul National University Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Pediatric patients under 7 years of age undergoing cardiac surgery with cardiopulmonary bypass

Preoperative serum albumin level of 4.0 g/dL or lower

Disqualifiers

abnormal preoperative creatinine level

history of dialysis

liver dysfunction

diabetes

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

190 Participants
are divided into 2 treatment groups
Group A: Albumin groupExperimental treatment 0 interventions
Group B: Control groupPlacebo comparator 0 interventions

Trial outcomes

Primary outcomes

1

incidence of acute kidney injury (AKI)

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

Time frame
assessed up to postoperative day 7

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Seoul National University Hospital

Lead sponsor

Source ClinicalTrials.gov
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