Acute Kidney Injury
Conditions
Keywords
crystalloid, colloid, children, infant, cardiac surgery
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.
Interventions
DRUGCrystalloid
normal saline administration for volume expansion in hypovolemic status
DRUGColloid
HES 130/0.4 administration for volume expansion in hypovolemic status
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 7 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Acute Kidney Injury | From the day of surgery to postoperative 7 days |
Secondary
| Measure | 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 |
Countries
South Korea
Outcome results
None listed