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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Acute Kidney Injury

Intervention / Treatment
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* Drug: Crystalloid
* Drug: Colloid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children aged less than 7 years old American Society of Anesthesiology (ASA) physical status 1-3 Exclusion Criteria: Preoperative creatinine > 1.5mg/dl History of dialysis Liver function abnormality Diabetes Mellitus History of allergic reaction Coagulation abnormality

Ages Eligible for Study
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Maximum Age: 7 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Crystalloid group<br>Crystalloid group receive only crystalloid for intravenous volume expansion. The same transfusion protocol is applied in both groups. | Drug: Crystalloid<br>* normal saline administration for volume expansion in hypovolemic status<br>* Other names: normal saline;|
| Active Comparator: Colloid group<br>Colloid group receive colloid preferentially for intravenous volume expansion, until 30 ml/kg. The same transfusion protocol is applied in both groups. | Drug: Colloid<br>* HES 130/0.4 administration for volume expansion in hypovolemic status<br>* Other names: HES 130/0.4;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute Kidney Injury |  | From the day of surgery to postoperative 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood loss |  | 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 | 
| Length of ICU stay |  | From the day of surgery to postoperative 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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crystalloid, colloid, children, infant, cardiac surgery