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Completed

NCT Number: NCT00860405

Voluven® in Paediatric Patients

This study will compare the clinical efficacy and safety of Voluven® and Human Albumin during elective open-heart surgery in pediatric patients.

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Key information

Conditions

Cardiac Surgery Cardiopulmonary Bypass

Age range

2 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

AKh Allgemeines Krankenhaus der Stadt Linz GmbH, Linz, Austria

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About this study

In the past, human albumin has been widely accepted as the therapeutic "gold standard" in paediatric volume replacement therapy because of the physiological hypoproteinemia in newborns and infants. In adult patients, artificial colloids such as hydroxyethyl starch have replaced human albumin as first choice in many settings. This study will compare the clinical efficacy and safety of HES 130/0.4 (6%) in normal saline vs. HSA 50g/L in volume replacement therapy during elective open-heart surgery in paediatric patients. The hypothesis of this study is to demonstrate that HES 130/0.4 (6%) and HSA 50g/L are equivalent regarding efficacy and provide comparable safety during elective open-heart surgery in paediatric patients 2 to 12 years of age.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male or female paediatric patient, 2 to 12 years of age, suffering from congenital heart-disease and undergoing elective open-heart surgery requiring ECC;
  • Signed parental written informed consent and patient assent where achievable

Exclusion criteria

  • Known contraindication against scheduled concomitant medication;
  • Total ECC volume < 400 mL;
  • ASA > III

Treatment and study plan

HES 130/0.4 (6%) in sodium chloride (Voluven®, solution for infusion), Human serum albumin (HSA 50g/L)

Drug

Study medication will be given as part of the priming of the ECC and for plasma volume replacement after start of ECC up to the maximum dosage of 50 mL/kg body weight/day.

Other names: Voluven®

Human serum albumin (HSA 50g/L)

Drug

Human serum albumin (HSA 50g/L)

Primary outcomes

  1. Total Volume of Colloid Solution Required Intraoperatively

    Time frame: Day 1 (intraoperatively)

    Total volume of study drug plus rescue colloid, if applicable

Secondary outcomes

  1. Mean Arterial Pressure (MAP)

    Time frame: Beginning of anaesthesia (baseline) until arrival on intensive care unit (ICU)

    Mean arterial pressure (MAP) from beginning of anaesthesia (baseline) until arrival on intensive care unit (ICU)

  2. Fluid Input

    Time frame: 2 days

    Quantity of total fluids administered from beginning of anaesthesia until 2nd postop morning

  3. Fluid Output

    Time frame: 2 days

    Quantity of total fluids excreted or lost from beginning of anaesthesia until 2nd postop morning

  4. Fluid Balance

    Time frame: 2 days

    Balance of total fluid input and total fluid output

Other outcomes

  1. Calculated Perioperative Red Blood Cell (RBC) Loss

    Time frame: 2 days

    Calculated perioperative RBC loss = Predicted blood volume1 × (hematocrit [baseline] - hematocrit [2nd postop morning]) + transfused RBC volume2;

    • Predicted blood volume (mL) = 80 × body weight (kg)
    • Transfused RBC volume = 0.7 × infused packed RBC

  2. Length of Stay on the Intensive Care Unit (ICU)

    Time frame: From admission to ICU until discharge from ICU

    Length of stay (number of days) on the intensive care unit (ICU).

  3. Mortality

    Time frame: From screening to end of follow-up

    Mortality was reported for the time period from screening until the end of follow-up.

  4. Acute Renal Failure (ARF)

    Time frame: From baseline until 2nd postop morning.

    Acute renal failure was defined as a two fold increase in serum creatinine concentration over the value at baseline at any time after baseline.

Sponsors and collaborators

Lead sponsor

Fresenius Kabi

Industry

Registry information

Official study title

Efficacy and Safety of 6 % Hydroxyethyl Starch 130/0.4 (Voluven®) vs. 5% HSA in Volume Replacement Therapy During Elective Open-heart Surgery in Paediatric Patients

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Mar 12, 2009
Registry last updated
Nov 2, 2011

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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