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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 22, 2014