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

Phase 3

Completed

• Conditions: Plasma Volume Substitution (Hypovolemia) Including Massive Hemorrhage

• Registration Number: NCT01127477
• Lead Sponsor: Fresenius Kabi Japan

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2010-05-17
• Study First Submitted QC: 2010-05-20
• Study First Posted: 2010-05-21
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2012-03
• Last Update Submitted: 2012-06-25
• Last Update Posted: 2012-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Volume Effect	Saved albumin: during surgery; Time course of hemodynamic stability: from end of surgery until 24 h after surgery	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

Name	Time	Method
Fluid Balance	From one day before (pediatric patients)/ immediately before (adults) induction of anesthesia until 48 hours after end of surgery	Fluid balance = fluid input vs. fluid output
Hemodynamics	From one day before (pediatric patients)/ immediately before (adults) induction of anesthesia until 48 hours after end of surgery
CVP	Immediately before or after induction of anesthesia (depending on routine procedures), every hour after skin incision, and 2 hours after surgery	Central venous pressure (CVP); not mandatory for pediatric patients
Hematology	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
Clinical Chemistry	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
Hemostasis	One day before (pediatric patients)/ immediately before (adults) induction of anesthesia, end of surgery (adults), 2 hours and 24 hours after end of surgery
Body Temperature	One day before (pediatric patients)/ immediately before (adults) induction of anesthesia, end of surgery, 2 hours and 24 hours after end of surgery
ECG	Screening, 2 hours and 24 hours after end of surgery	Not mandatory for pediatric patients
Urinalysis	Immediately before or after induction of anesthesia (depending on routine procedures) and 24 hours after surgery	Not mandatory for pediatric patients
Local and Systemic Tolerance	After each administration of study drug
(Serious) Adverse Events	From signing informed consent until 28 days follow up

Trial Locations

Locations (4)

Sapporo Medical University, School of Medicine; 🇯🇵 Sapporo, Hokkaido, Japan

Okayama University; 🇯🇵 Okayama, Japan

National Center for Child Health and Development; 🇯🇵 Tokyo, Japan

Tokyo Women's Medical University; 🇯🇵 Tokyo, Japan