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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Crystalloid group | Placebo Comparator | Crystalloid group receive only crystalloid for intravenous volume expansion. The same transfusion protocol is applied in both groups. |
|
| Colloid group | Active Comparator | Colloid group receive colloid preferentially for intravenous volume expansion, until 30 ml/kg. The same transfusion protocol is applied in both groups. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Crystalloid | Drug | normal saline administration for volume expansion in hypovolemic status |
|
| Measure | Description | Time Frame |
|---|---|---|
| Acute Kidney Injury | From the day of surgery to postoperative 7 days |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jin-Tae Kim, PhD | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul national university hospital | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29150842 | Derived | Oh HW, Lee JH, Kim HC, Kim EH, Song IK, Kim HS, Kim JT. The effect of 6% hydroxyethyl starch (130/0.4) on acute kidney injury in paediatric cardiac surgery: a prospective, randomised trial. Anaesthesia. 2018 Feb;73(2):205-215. doi: 10.1111/anae.14129. Epub 2017 Nov 17. |
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| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D000077330 | Saline Solution |
| D003102 | Colloids |
| D006895 | Hydroxyethyl Starch Derivatives |
| ID | Term |
|---|---|
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D045424 | Complex Mixtures |
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| Colloid | Drug | HES 130/0.4 administration for volume expansion in hypovolemic status |
|
|
| From the day of surgery to postoperative 7 days |
| Length of ICU stay | From the day of surgery to postoperative 7 days |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D004304 |
| Dosage Forms |
| D013213 | Starch |
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D005936 | Glucans |
| D011134 | Polysaccharides |