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NCT Number: 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

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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Key information

Conditions

Plasma Volume Substitution (Hypovolemia) Including Massive Hemorrhage Blood Loss, Surgical Hemorrhage Hypovolemia Intraoperative Complications Pathologic Processes Pathological Conditions, Signs and Symptoms

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Sapporo Medical University, School of Medicine, Sapporo, Hokkaido, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

1: Hydroxyethyl starch 130/0.4, 6 %

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.

Primary outcomes

  1. Volume Effect

    Time frame: 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:

    • 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

Secondary outcomes

  1. Fluid Balance

    Time frame: 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

  2. Hemodynamics

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

  3. CVP

    Time frame: 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. ECG

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

    Not mandatory for pediatric patients

  9. Urinalysis

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

    Not mandatory for pediatric patients

  10. Local and Systemic Tolerance

    Time frame: After each administration of study drug

  11. (Serious) Adverse Events

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

Sponsors and collaborators

Lead sponsor

Fresenius Kabi Japan

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
May 21, 2010
Registry last updated
Jun 26, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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