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 Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2010-12-31

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.

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Detailed Description

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Conditions

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Plasma Volume Substitution (Hypovolemia) Including Massive Hemorrhage

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

1: Hydroxyethyl starch 130/0.4, 6 %

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No