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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Fresenius Kabi ( Fresenius Kabi Japan )
ClinicalTrials.gov Identifier:
NCT01127477
First received: May 17, 2010
Last updated: June 25, 2012
Last verified: March 2012
  Purpose

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 Intervention Phase
Plasma Volume Substitution (Hypovolemia) Including Massive Hemorrhage
Drug: 1: Hydroxyethyl starch 130/0.4, 6 %
Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Fresenius Kabi:

Primary Outcome Measures:
  • Volume Effect [ Time Frame: Saved albumin: during surgery; Time course of hemodynamic stability: from end of surgery until 24 h after surgery ] [ Designated as safety issue: No ]

    Volume effect will be assessed by evaluating the following parameter:

    1. 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.

    2. Time course of hemodynamic stability


Secondary Outcome Measures:
  • Fluid Balance [ Time Frame: From one day before (pediatric patients)/ immediately before (adults) induction of anesthesia until 48 hours after end of surgery ] [ Designated as safety issue: Yes ]
    Fluid balance = fluid input vs. fluid output

  • Hemodynamics [ Time Frame: From one day before (pediatric patients)/ immediately before (adults) induction of anesthesia until 48 hours after end of surgery ] [ Designated as safety issue: Yes ]
  • CVP [ Time Frame: Immediately before or after induction of anesthesia (depending on routine procedures), every hour after skin incision, and 2 hours after surgery ] [ Designated as safety issue: Yes ]
    Central venous pressure (CVP); not mandatory for pediatric patients

  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • ECG [ Time Frame: Screening, 2 hours and 24 hours after end of surgery ] [ Designated as safety issue: Yes ]
    Not mandatory for pediatric patients

  • Urinalysis [ Time Frame: Immediately before or after induction of anesthesia (depending on routine procedures) and 24 hours after surgery ] [ Designated as safety issue: Yes ]
    Not mandatory for pediatric patients

  • Local and Systemic Tolerance [ Time Frame: After each administration of study drug ] [ Designated as safety issue: Yes ]
  • (Serious) Adverse Events [ Time Frame: From signing informed consent until 28 days follow up ] [ Designated as safety issue: Yes ]

Enrollment: 20
Study Start Date: May 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01127477

Locations
Japan
Sapporo Medical University, School of Medicine
Sapporo, Hokkaido, Japan, 060-8543
Okayama University
Okayama, Japan, 700-8558
National Center for Child Health and Development
Tokyo, Japan, 157-8535
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
  More Information

No publications provided

Responsible Party: Fresenius Kabi ( Fresenius Kabi Japan )
ClinicalTrials.gov Identifier: NCT01127477     History of Changes
Other Study ID Numbers: HE06-008-CP3
Study First Received: May 17, 2010
Last Updated: June 25, 2012
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Fresenius Kabi:
Hypovolemia, surgical blood loss

Additional relevant MeSH terms:
Hemorrhage
Hypovolemia
Pathologic Processes
Hetastarch
Plasma Substitutes
Blood Substitutes
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014