Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The study shall evaluate the volume effect and safety of 6 % hydroxyethyl starch 130/0.4 for restoration and maintenance of hemodynamics during the investigational period in patients undergoing major elective surgery. Up to 50 mL 6% hydroxyethyl starch/kg body weight will be administered from start of surgery until two hours after end of surgery. The study hypothesis is that 6 % hydroxyethyl starch 130/0.4 will have a reliable volume effect and can be safely administered up to the dose limit.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1: Hydroxyethyl starch 130/0.4, 6 % | Drug | 1: Up to 50 ml 6 % hydroxyethyl starch 130/0.4/kg body weight administered intravenously from start of surgery (skin incision) until two hours after end of surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Volume Effect | Volume effect will be assessed by evaluating the following parameter:
| Saved albumin: during surgery; Time course of hemodynamic stability: from end of surgery until 24 h after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Fluid Balance | Fluid balance = fluid input vs. fluid output | From one day before (pediatric patients)/ immediately before (adults) induction of anesthesia until 48 hours after end of surgery |
| Hemodynamics |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Akiyoshi Namiki, MD, PhD | Emeritus Professor Sapporo Medical University; CEO, Otaru City Hospitals, Hokkaido, Japan | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sapporo Medical University, School of Medicine | Sapporo | Hokkaido | 060-8543 | Japan | ||
| Okayama University |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| From one day before (pediatric patients)/ immediately before (adults) induction of anesthesia until 48 hours after end of surgery |
| CVP | Central venous pressure (CVP); not mandatory for pediatric patients | Immediately before or after induction of anesthesia (depending on routine procedures), every hour after skin incision, and 2 hours after surgery |
| Hematology | One day before (pediatric patients)/ immediately before (adults) induction of anesthesia, every hour after skin incision (adults), end of surgery (adults), 2 hours and 24 hours after end of surgery |
| Clinical Chemistry | One day before (pediatric patients)/ immediately before (adults) induction of anesthesia, end of surgery (adults), 2 hours after end of surgery (pediatric patients), and 24 hours after end of surgery |
| Hemostasis | One day before (pediatric patients)/ immediately before (adults) induction of anesthesia, end of surgery (adults), 2 hours and 24 hours after end of surgery |
| Body Temperature | One day before (pediatric patients)/ immediately before (adults) induction of anesthesia, end of surgery, 2 hours and 24 hours after end of surgery |
| ECG | Not mandatory for pediatric patients | Screening, 2 hours and 24 hours after end of surgery |
| Urinalysis | Not mandatory for pediatric patients | Immediately before or after induction of anesthesia (depending on routine procedures) and 24 hours after surgery |
| Local and Systemic Tolerance | After each administration of study drug |
| (Serious) Adverse Events | From signing informed consent until 28 days follow up |
| Okayama |
| 700-8558 |
| Japan |
| National Center for Child Health and Development | Tokyo | 157-8535 | Japan |
| Tokyo Women's Medical University | Tokyo | 162-8666 | Japan |
| ID | Term |
|---|---|
| D020896 | Hypovolemia |
| D016063 | Blood Loss, Surgical |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006470 | Hemorrhage |
| D007431 | Intraoperative Complications |
Not provided
Not provided