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

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

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2016-03-31

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.

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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.

Conditions

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Acute Kidney Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Crystalloid group

Crystalloid group receive only crystalloid for intravenous volume expansion. The same transfusion protocol is applied in both groups.

Group Type PLACEBO_COMPARATOR

Crystalloid

Intervention Type DRUG

normal saline administration for volume expansion in hypovolemic status

Colloid group

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

Group Type ACTIVE_COMPARATOR

Colloid

Intervention Type DRUG

HES 130/0.4 administration for volume expansion in hypovolemic status

Interventions

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Crystalloid

normal saline administration for volume expansion in hypovolemic status

Intervention Type DRUG

Colloid

HES 130/0.4 administration for volume expansion in hypovolemic status

Intervention Type DRUG

Other Intervention Names

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normal saline HES 130/0.4

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

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes