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

Primary Purpose

Plasma Volume Substitution (Hypovolemia) Including Massive Hemorrhage

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
1: Hydroxyethyl starch 130/0.4, 6 %
Sponsored by
Fresenius Kabi Japan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Plasma Volume Substitution (Hypovolemia) Including Massive Hemorrhage focused on measuring Hypovolemia, surgical blood loss

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sapporo Medical University, School of Medicine
  • Okayama University
  • National Center for Child Health and Development
  • Tokyo Women's Medical University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Fluid Balance
Fluid balance = fluid input vs. fluid output
Hemodynamics
CVP
Central venous pressure (CVP); not mandatory for pediatric patients
Hematology
Clinical Chemistry
Hemostasis
Body Temperature
ECG
Not mandatory for pediatric patients
Urinalysis
Not mandatory for pediatric patients
Local and Systemic Tolerance
(Serious) Adverse Events

Full Information

First Posted
May 17, 2010
Last Updated
June 25, 2012
Sponsor
Fresenius Kabi Japan
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1. Study Identification

Unique Protocol Identification Number
NCT01127477
Brief Title
Study to Obtain Volume Effect and Safety Data on 6 % Hydroxyethyl Starch 130/0.4 in Pediatric and Adult Patients Undergoing Major Elective Surgery
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fresenius Kabi Japan

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plasma Volume Substitution (Hypovolemia) Including Massive Hemorrhage
Keywords
Hypovolemia, surgical blood loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
1: Hydroxyethyl starch 130/0.4, 6 %
Intervention Description
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.
Primary Outcome Measure Information:
Title
Volume Effect
Description
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
Time Frame
Saved albumin: during surgery; Time course of hemodynamic stability: from end of surgery until 24 h after surgery
Secondary Outcome Measure Information:
Title
Fluid Balance
Description
Fluid balance = fluid input vs. fluid output
Time Frame
From one day before (pediatric patients)/ immediately before (adults) induction of anesthesia until 48 hours after end of surgery
Title
Hemodynamics
Time Frame
From one day before (pediatric patients)/ immediately before (adults) induction of anesthesia until 48 hours after end of surgery
Title
CVP
Description
Central venous pressure (CVP); not mandatory for pediatric patients
Time Frame
Immediately before or after induction of anesthesia (depending on routine procedures), every hour after skin incision, and 2 hours after surgery
Title
Hematology
Time Frame
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
Title
Clinical Chemistry
Time Frame
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
Title
Hemostasis
Time Frame
One day before (pediatric patients)/ immediately before (adults) induction of anesthesia, end of surgery (adults), 2 hours and 24 hours after end of surgery
Title
Body Temperature
Time Frame
One day before (pediatric patients)/ immediately before (adults) induction of anesthesia, end of surgery, 2 hours and 24 hours after end of surgery
Title
ECG
Description
Not mandatory for pediatric patients
Time Frame
Screening, 2 hours and 24 hours after end of surgery
Title
Urinalysis
Description
Not mandatory for pediatric patients
Time Frame
Immediately before or after induction of anesthesia (depending on routine procedures) and 24 hours after surgery
Title
Local and Systemic Tolerance
Time Frame
After each administration of study drug
Title
(Serious) Adverse Events
Time Frame
From signing informed consent until 28 days follow up

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Akiyoshi Namiki, MD, PhD
Organizational Affiliation
Emeritus Professor Sapporo Medical University; CEO, Otaru City Hospitals, Hokkaido, Japan
Official's Role
Study Chair
Facility Information:
Facility Name
Sapporo Medical University, School of Medicine
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-8543
Country
Japan
Facility Name
Okayama University
City
Okayama
ZIP/Postal Code
700-8558
Country
Japan
Facility Name
National Center for Child Health and Development
City
Tokyo
ZIP/Postal Code
157-8535
Country
Japan
Facility Name
Tokyo Women's Medical University
City
Tokyo
ZIP/Postal Code
162-8666
Country
Japan

12. IPD Sharing Statement

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

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