The Effect of the Hydroxyethyl Starch on Kidney Injury in Pediatric Cardiac Surgery

Not Applicable

Completed

• Conditions: Acute Kidney Injury
• Interventions: Drug: Crystalloid; Drug: Colloid

• Registration Number: NCT02599155
• Lead Sponsor: Seoul National University Hospital

Brief Summary

The investigator will evaluate the influence of colloid administration on postoperative acute kidney injury in pediatric patients undergoing cardiac surgery under cardiopulmonary bypass.

Detailed Description

The investigator will randomly divide pediatric patients aged less than 7 years old into crystalloid and colloid groups. Crystalloid group receive only crystalloid, and colloid group receive hydroxyethyl starch (HES, 130/0.4). The maximum volume of HES is limited less than 30 ml/kg. The same transfusion protocol will be applied in both groups. From the day of operation to postoperative 7 days, glomerular filtration rate (GFR), serum creatinin level (Cr) will be checked. Acute kidney injury (AKI) is defined when there is more than 50% increase in Cr when compared to baseline level. The investigator will compare the clinical outcomes including AKI between two groups.

Study Timeline

• Study Start: 2015-11
• Study First Submitted: 2015-11-03
• Study First Submitted QC: 2015-11-04
• Study First Posted: 2015-11-06
• Primary Completion: 2016-02
• Study Completion: 2016-03
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-22
• Last Update Posted: 2017-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Children aged less than 7 years old
• American Society of Anesthesiology (ASA) physical status 1-3

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Exclusion Criteria

• Preoperative creatinine > 1.5mg/dl
• History of dialysis
• Liver function abnormality
• Diabetes Mellitus
• History of allergic reaction
• Coagulation abnormality

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Crystalloid group	Crystalloid	Crystalloid group receive only crystalloid for intravenous volume expansion. The same transfusion protocol is applied in both groups.
Colloid group	Colloid	Colloid group receive colloid preferentially for intravenous volume expansion, until 30 ml/kg. The same transfusion protocol is applied in both groups.

Primary Outcome Measures

Name	Time	Method
Acute Kidney Injury	From the day of surgery to postoperative 7 days

Secondary Outcome Measures

Name	Time	Method
Blood loss	From the day of surgery to postoperative 7 days
Length of ICU stay	From the day of surgery to postoperative 7 days
Transfusion amount	From the day of surgery to postoperative 7 days
Mechanical ventilation time	From the day of surgery to postoperative 7 days

Trial Locations

Locations (1)

Seoul national university hospital; 🇰🇷 Seoul, Korea, Republic of