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Recent studies have shown an increased incidence of renal replacement therapy after the use of Hydroxyethylstarchs (HES) in patients admitted in the intensive care unit. However, studies showing detrimental effects of HES have been conducted in mostly non-surgical subjects. There are very few studies analyzing the effects of HES on renal function after cardiac surgery, a population already at risk of renal dysfunction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hydroxyethylstarch 6% 130/0.4 | Experimental | These patients have received Hydroxyethylstarch 6% 130/0.4 intraoperatively or postoperatively in addition to standard volume therapy. |
|
| No Hydroxyethylstarch 6% 130/0.4 | Active Comparator | These patients have not received Hydroxyethylstarch 6% 130/0.4 at any time point. Only standard volume therapy has been used. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydroxyethylstarch 6% 130/0.4 | Drug | Use of Hydroxyethylstarch intraoperatively, for cardiopulmonary bypass use and postoperatively in the intensive care unit |
|
| Measure | Description | Time Frame |
|---|---|---|
| Renal dysfunction based on RIFLE (Risk; Injury; Failure; Loss; End-stage) criteria. | Up to 45 days |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | Up to 45 days |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D006895 | Hydroxyethyl Starch Derivatives |
| ID | Term |
|---|---|
| D013213 | Starch |
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D005936 | Glucans |
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|
| standard volume therapy | Other |
|
| D011134 |
| Polysaccharides |