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

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:

Drug Information available for: Hetastarch

U.S. FDA Resources

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 June 18, 2013