Voluven® in Paediatric Patients

• ClinicalTrials.gov Identifier: NCT00860405
• Recruitment Status: Completed
• First Posted: March 12, 2009
• Results First Posted: September 19, 2011
• Last Update Posted: November 2, 2011
• Sponsor: Fresenius Kabi
• Information provided by (Responsible Party): Fresenius Kabi

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Cardiac Surgery; Cardiopulmonary Bypass	Drug: HES 130/0.4 (6%) in sodium chloride (Voluven®, solution for infusion), Human serum albumin (HSA 50g/L); Drug: Human serum albumin (HSA 50g/L)	Phase 4

Detailed Description:

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 61 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official 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
• Study Start Date: March 2009
• Actual Primary Completion Date: August 2010
• Actual Study Completion Date: December 2010

Arms and Interventions

Arm	Intervention/treatment
Experimental: 1; Investigational drug: HES 130/0.4 (6%) in sodium chloride (Voluven®, solution for infusion)	Drug: HES 130/0.4 (6%) in sodium chloride (Voluven®, solution for infusion), Human serum albumin (HSA 50g/L); 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 Name: Voluven®
Active Comparator: 2; Control drug: Human serum albumin (HSA 50g/L)	Drug: Human serum albumin (HSA 50g/L); Human serum albumin (HSA 50g/L)

Outcome Measures

Primary Outcome Measures :

1. Total Volume of Colloid Solution Required Intraoperatively [ Time Frame: Day 1 (intraoperatively) ]
   Total volume of study drug plus rescue colloid, if applicable

Secondary Outcome Measures :

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 Outcome Measures:

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;

   1. Predicted blood volume (mL) = 80 × body weight (kg)
   2. 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.

Eligibility Criteria

• Ages Eligible for Study: 2 Years to 12 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

Austria

AKh Allgemeines Krankenhaus der Stadt Linz GmbH

Linz, Austria, 4021

Belgium

HUDERF - Hôpital Universitaire des Enfants Reine Fabiola

Brussels, Belgium, 1020

Sponsors and Collaborators

Fresenius Kabi

Investigators

• Principal Investigator: Philippe Van der Linden, Professor; HUDERF - Hôpital Universitaire des Enfants Reine Fabiola
• Principal Investigator: Hans Gombotz, Professor; AKh Allgemeines Krankenhaus der Stadt Linz GmbH

More Information

• Responsible Party: Fresenius Kabi
• ClinicalTrials.gov Identifier: NCT00860405
• Other Study ID Numbers: HE06-001-C P4
• First Posted: March 12, 2009
• Results First Posted: September 19, 2011
• Last Update Posted: November 2, 2011
• Last Verified: October 2011

Additional relevant MeSH terms:

Hydroxyethyl Starch Derivatives; Plasma Substitutes; Blood Substitutes