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

Seoul National University

Status: Completed

Conditions: Acute Kidney Injury

Treatments: Drug: Crystalloid; Drug: Colloid

Study type: Interventional

Funder types: Other

Identifiers

NCT02599155

H1507-061-687

Details and patient eligibility

About

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

Full 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.

Enrollment: 200 patients

Sex: All

Ages: Under 7 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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200 participants in 2 patient groups, including a placebo group

Crystalloid group

Placebo Comparator group

Description:

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

Treatment:

Drug: Crystalloid

Colloid group

Active Comparator group

Description:

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

Treatment:

Drug: Colloid