Study to Obtain Volume Effect and Safety Data on 6 % Hydroxyethyl Starch 130/0.4 in Pediatric and Adult Patients Undergoing Major Elective Surgery

Examination of Volume Effect and Safety of 6 % Hydroxyethyl Starch 130/0.4 in Patients Undergoing Major Elective Surgery - an Uncontrolled, Open-labelled, Multi-centre Study

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.

Study Overview

• Status: Completed
• Conditions: Plasma Volume Substitution (Hypovolemia) Including Massive Hemorrhage
• Intervention / Treatment: Drug: 1: Hydroxyethyl starch 130/0.4, 6 %

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 3

Contacts and Locations

Study Locations

• Japan
  • Okayama, Japan, 700-8558
    • Okayama University
  • Tokyo, Japan, 162-8666
    • Tokyo Women's Medical University
  • Tokyo, Japan, 157-8535
    • National Center for Child Health and Development
  • Hokkaido
    • Sapporo, Hokkaido, Japan, 060-8543
      • Sapporo Medical University, School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

• Known or suspected allergy to hydroxyethyl starch, including its ingredients (inclusive corn) and related drugs
• ASA classification ≥ IV
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Volume Effect	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	Saved albumin: during surgery; Time course of hemodynamic stability: from end of surgery until 24 h after surgery

Secondary Outcome Measures

Outcome Measure	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		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

Collaborators and Investigators

• Sponsor: Fresenius Kabi Japan
• Investigators: Study Chair: Akiyoshi Namiki, MD, PhD, Emeritus Professor Sapporo Medical University; CEO, Otaru City Hospitals, Hokkaido, Japan

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): December 1, 2010

Study Registration Dates

• First Submitted: May 17, 2010
• First Submitted That Met QC Criteria: May 20, 2010
• First Posted (Estimate): May 21, 2010

Study Record Updates

• Last Update Posted (Estimate): June 26, 2012
• Last Update Submitted That Met QC Criteria: June 25, 2012
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Keywords: Hypovolemia, surgical blood loss
• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage; Hypovolemia; Plasma Substitutes; Blood Substitutes; Hydroxyethyl Starch Derivatives
• Other Study ID Numbers: HE06-008-CP3