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The study shall evaluate the efficacy and safety of two different hydroxyethyl starch solutions (artificial colloids 6% HES130/0.4 and 6% HES70/0.5, Salinhes®) for intra-operative therapy of hypovolemia and maintenance of circulating blood volume in patients undergoing orthopedic surgery. The primary efficacy endpoint will be the required volume of colloid solution infused from start until end of surgery. It is the aim of the clinical trial to demonstrate that comparable volumes of colloid solution are used between treatment groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Up to 1000mL 6% hydroxyethyl starch 130/0.4 solution i.v., intra-operatively (from start of surgery until end of surgery) |
|
| 2 | Active Comparator | Up to 1000mL 6% hydroxyethyl starch 70/0.5 (Salinhes®) solution i.v., intra-operatively (from start of surgery until end of surgery) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 6% hydroxyethyl starch 130/0.4 | Drug | Up to 1000mL 6% hydroxyethyl starch 130/0.4 solution i.v., intra-operatively (from start of surgery until end of surgery) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Volume of colloid solution infused during investigational period (= intra-operatively) | Intra-operatively |
| Measure | Description | Time Frame |
|---|---|---|
| Fluid input | From immediately before induction of anesthesia until 48 hours after end of surgery | |
| Fluid output | From immediately before induction of anesthesia until 48 hours after end of surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Akiyoshi Namiki, MD, PhD | Emeritus Professor, Sapporo Medical University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sapporo Medical University, School of Medicine | Sapporo | Hokkaido | 060-8543 | Japan | ||
| Kyushu University, Graduate School of Medical Sciences |
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| ID | Term |
|---|---|
| D020896 | Hypovolemia |
| D006470 | Hemorrhage |
| D016063 | Blood Loss, Surgical |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007431 | Intraoperative Complications |
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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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| 6% hydroxyethyl starch 70/0.5 (Salinhes®) | Drug | Up to 1000mL 6% hydroxyethyl starch 70/0.5 (Salinhes®) solution i.v., intra-operatively (from start of surgery until end of surgery) |
|
| Fluid balance | From immediately before induction of anesthesia until 48 hours after end of surgery |
| Hemodynamics | From immediately before induction of anesthesia until 48 hours after end of surgery |
| Co-administration of vasoactive drugs | From enrolment until 48 hours after end of surgery |
| Fukuoka |
| 812-8582 |
| Japan |
| Kobe University Graduate School of Medicine | Kobe | 650-0017 | Japan |
| Okayama University | Okayama | 700-8558 | Japan |
| Osaka University Graduate School of Medicine | Osaka | 565-0871 | Japan |
| Keio University School of Medicine | Tokyo | 160-8582 | Japan |
| Tokyo Women's Medical University | Tokyo | 162-8666 | Japan |
| D011134 |
| Polysaccharides |