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

Fresenius Kabi Japan20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Plasma Volume Substitution (Hypovolemia) Including Massive Hemorrhage

Interventions

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

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

Outcomes

Primary Outcomes

Volume Effect

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

Time frame: Saved albumin: during surgery; Time course of hemodynamic stability: from end of surgery until 24 h after surgery

Secondary Outcomes

Fluid Balance

Fluid balance = fluid input vs. fluid output

Time frame: From one day before (pediatric patients)/ immediately before (adults) induction of anesthesia until 48 hours after end of surgery

Hemodynamics

Time frame: From one day before (pediatric patients)/ immediately before (adults) induction of anesthesia until 48 hours after end of surgery

CVP

Central venous pressure (CVP); not mandatory for pediatric patients

Time frame: Immediately before or after induction of anesthesia (depending on routine procedures), every hour after skin incision, and 2 hours after surgery

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

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

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

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

ECG

Not mandatory for pediatric patients

Time frame: Screening, 2 hours and 24 hours after end of surgery

Urinalysis

Not mandatory for pediatric patients

Time frame: Immediately before or after induction of anesthesia (depending on routine procedures) and 24 hours after surgery

Local and Systemic Tolerance

Time frame: After each administration of study drug

(Serious) Adverse Events

Time frame: From signing informed consent until 28 days follow up