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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Plasma Volume Substitution (Hypovolemia) Including Massive Hemorrhage

Intervention / Treatment
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* Drug: 1: Hydroxyethyl starch 130/0.4, 6 %


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: 1: Hydroxyethyl starch 130/0.4, 6 %<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Volume Effect | Volume effect will be assessed by evaluating the following parameter: 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. Time course of hemodynamic stability | Saved albumin: during surgery; Time course of hemodynamic stability: from end of surgery until 24 h after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fluid Balance | Fluid balance = fluid input vs. fluid output | From one day before (pediatric patients)/ immediately before (adults) induction of anesthesia until 48 hours after end of surgery | 
| Hemodynamics |  | 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 | Immediately before or after induction of anesthesia (depending on routine procedures), every hour after skin incision, and 2 hours after surgery | 
| 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 | Not mandatory for pediatric patients | Screening, 2 hours and 24 hours after end of surgery | 
| Urinalysis | Not mandatory for pediatric patients | Immediately before or after induction of anesthesia (depending on routine procedures) and 24 hours after surgery | 
| Local and Systemic Tolerance |  | After each administration of study drug | 
| (Serious) Adverse Events |  | From signing informed consent until 28 days follow up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypovolemia, surgical blood loss