Clinical trial NCT01127477: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Plasma Volume Substitution (Hypovolemia) Including Massive Hemorrhage
Keywords: Hypovolemia, surgical blood loss
Lead sponsor: Fresenius Kabi
Sponsor class: INDUSTRY
First posted: 2010-05-21
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Volume Effect
timeFrame: Saved albumin: during surgery; Time course of hemodynamic stability: from end of surgery until 24 h after surgery
Secondary outcomes:
measure: Fluid Balance
timeFrame: From one day before (pediatric patients)/ immediately before (adults) induction of anesthesia until 48 hours after end of surgery
measure: Hemodynamics
timeFrame: From one day before (pediatric patients)/ immediately before (adults) induction of anesthesia until 48 hours after end of surgery
measure: CVP
timeFrame: Immediately before or after induction of anesthesia (depending on routine procedures), every hour after skin incision, and 2 hours after surgery
measure: Hematology
timeFrame: 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
measure: Clinical Chemistry
timeFrame: 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
measure: Hemostasis
timeFrame: One day before (pediatric patients)/ immediately before (adults) induction of anesthesia, end of surgery (adults), 2 hours and 24 hours after end of surgery
measure: Body Temperature
timeFrame: One day before (pediatric patients)/ immediately before (adults) induction of anesthesia, end of surgery, 2 hours and 24 hours after end of surgery
measure: ECG
timeFrame: Screening, 2 hours and 24 hours after end of surgery
measure: Urinalysis
timeFrame: Immediately before or after induction of anesthesia (depending on routine procedures) and 24 hours after surgery
measure: Local and Systemic Tolerance
timeFrame: After each administration of study drug
measure: (Serious) Adverse Events
timeFrame: From signing informed consent until 28 days follow up
Other outcomes:
Locations:
city: Sapporo
country: Japan
facility: Sapporo Medical University, School of Medicine
state: Hokkaido
city: Okayama
country: Japan
facility: Okayama University
city: Tokyo
country: Japan
facility: National Center for Child Health and Development
city: Tokyo
country: Japan
facility: Tokyo Women's Medical University
Study officials:
affiliation: Emeritus Professor Sapporo Medical University; CEO, Otaru City Hospitals, Hokkaido, Japan
name: Akiyoshi Namiki, MD, PhD
role: STUDY_CHAIR
References: