Study to Obtain Volume Effect and Safety Data on 6 % Hydroxyethyl Starch 130/0.4 in Pediatric and Adult Patients Undergoing Major Elective Surgery
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 1
|
Drug: 1: Hydroxyethyl starch 130/0.4, 6 %
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.
|
Outcome Measures
Primary Outcome Measures
- Volume Effect [Saved albumin: during surgery; Time course of hemodynamic stability: from end of surgery until 24 h after surgery]
Volume effect will be assessed by evaluating the following parameter: Saved albumin: For adult patients: Amount of 6 % hydroxyethyl starch 130/0.4 (HES130) administered during surgery once 1000 mL of HES130 are exceeded. For pediatric patients: Amount of HES130 administered during surgery once 10 mL HES130/kg body weight are exceeded. Time course of hemodynamic stability
Secondary Outcome Measures
- Fluid Balance [From one day before (pediatric patients)/ immediately before (adults) induction of anesthesia until 48 hours after end of surgery]
Fluid balance = fluid input vs. fluid output
- Hemodynamics [From one day before (pediatric patients)/ immediately before (adults) induction of anesthesia until 48 hours after end of surgery]
- CVP [Immediately before or after induction of anesthesia (depending on routine procedures), every hour after skin incision, and 2 hours after surgery]
Central venous pressure (CVP); not mandatory for pediatric patients
- 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 [Screening, 2 hours and 24 hours after end of surgery]
Not mandatory for pediatric patients
- Urinalysis [Immediately before or after induction of anesthesia (depending on routine procedures) and 24 hours after surgery]
Not mandatory for pediatric patients
- Local and Systemic Tolerance [After each administration of study drug]
- (Serious) Adverse Events [From signing informed consent until 28 days follow up]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patients undergoing major elective surgery
-
Adults patients (≥20 years of age): expected blood loss of ≥ 1000mL Pediatric patients (<20 years of age): expected blood loss ≥ 15 mL/kg
-
Adult patients: Routine measurement of Central Venous Pressure (CVP)
Exclusion Criteria:
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Known or suspected allergy to hydroxyethyl starch, including its ingredients (inclusive corn) and related drugs
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ASA classification ≥ IV
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Adult patients: renal failure with oliguria (<400 mL urin /24hours) and anuria Pediatric patients: renal failure with oliguria and anuria not related to hypovolemia
-
Known bleeding disorders
-
Other contra-indications according to the current SmPC of Voluven 6% solution for infusion.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sapporo Medical University, School of Medicine | Sapporo | Hokkaido | Japan | 060-8543 |
| 2 | Okayama University | Okayama | Japan | 700-8558 | |
| 3 | National Center for Child Health and Development | Tokyo | Japan | 157-8535 | |
| 4 | Tokyo Women's Medical University | Tokyo | Japan | 162-8666 |
Sponsors and Collaborators
- Fresenius Kabi Japan
Investigators
- Study Chair: Akiyoshi Namiki, MD, PhD, Emeritus Professor Sapporo Medical University; CEO, Otaru City Hospitals, Hokkaido, Japan
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HE06-008-CP3