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This trial aims to compare two intraoperative fluids, namely hydroxyethyl starch (HES) and balanced crystalloids in terms of major adverse kidney events after cardiac surgery. Indications for the study fluids administarion include preload augmentation and intravascular volume replacement during cardiac surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hydroxyethyl starch | Experimental | Hydroxyethyl starch is used (up to 20 mL/kg) when acute volume resuscitation is required (e.g., preload augmentation, intravascular volume replacement) during cardiac surgery |
|
| Ballanced crystalloid | Active Comparator | Balanced crystalloids are used instead of HES for the same indications as those in the HES group (when acute volume resuscitation is required [e.g., preload augmentation, intravascular volume replacement] during cardiac surgery). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Volulyte® (6% HES 130/0.4 in balanced solution) | Drug | Hydroxyethyl starch is used (up to 20 mL/kg) when acute volume resuscitation is required (e.g., preload augmentation, intravascular volume replacement) during cardiac surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of major adverse kidney events (MAKE) | The incidence of a composite outcome consinsting of all-cause mortality (patients who dies from any cause after surgery), stage 2 (an increase in serum creatinine to 2.0-2.9 times the baseline value) or stage 3 (an increase in serum creatinine to ≥3.0 times the baseline value or to an absolute level of ≥4.0 mg/dL) acute kidney injury, or new requirement for renal replacement therapy (de novo renal replacement therapy after surgery among patients who were renal replacement therapy-naive before surgery). | For up to 7 days post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Generalized average real variability | The sum of absolute differences between consecutive mean arterial pressure measurements, divided by the total monitoring duration from the first to the last measurement. | From intensive card unit admission after surgery to 6 hours post-admission |
| Vasopressor-free days |
| Measure | Description | Time Frame |
|---|---|---|
| Chest tube drainage during the first 12 hours after surgery (mL) | The cumulative volume of blood collected through the chest tube | The first 12 hours following the completion of surgery |
| Incidence of reoperation for postoperative bleeding control |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Karam Nam, M.D., Ph.D. | Contact | +82 2 2072 0643 | karamnam@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chungnam National University Hospital | Recruiting | Daejeon | 35015 | South Korea | ||
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| ID | Term |
|---|---|
| D006895 | Hydroxyethyl Starch Derivatives |
| D000077324 | Crystalloid Solutions |
| ID | Term |
|---|---|
| D013213 | Starch |
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D005936 | Glucans |
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| Crystalloid solutions | Drug | Balanced crystalloids are used instead of HES for the same indications as those in the HES group (when acute volume resuscitation is required [e.g., preload augmentation, intravascular volume replacement] during cardiac surgery). |
|
The number of days alive and free from intravenous vasopressor support (e.g., dopamine, phenylephrine, epinephrine, norepinephrine, or vasopressin) |
| For up to 7 days post-surgery |
| Peak increase in serum creatinine | the maximum increase in serum creatinine from the preoperative baseline during the first 3 postoperative days | From entollment to postoperative day 3 |
| Maximum stage of acute kidney injury | From the end of surgery to postoperative day 7 |
The proportion of patients requiring an unplanned return to the operating room for the purpose of controlling hemorrhage after initial operating theater exit.
| For up to 7 days post-surgery. |
| Plasma neutrophil gelatinase-associated lipocalin concentration | Measured once at the end of surgery |
| Perioperative change in body weight | the difference between the first postoperative weight measurement and the most recent preoperative weight measurement (kg) | From the most recent weight measurement before surgery until the first postoperative weight is recorded, typically spanning from the day before surgery to within several hours of the operation's completion. |
| Time to extubation | the interval from postoperative intensive care unit admission until the planned removal of the endotracheal tube. | From the time of transfer to the ICU following surgery until ICU discharge, which occurs within 3-4 days postoperatively on average. |
| Incidence of major adverse kidney events | For up to 30 days post-surgery |
| Korea University Guro Hospital |
| Recruiting |
| Seoul |
| 03080 |
| South Korea |
| Seoul National University Hospital | Recruiting | Seoul | 03080 | South Korea |
|
| Severance Hospital | Recruiting | Seoul | 03080 | South Korea |
| D011134 |
| Polysaccharides |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |