Cardiac SurgeryPhase 4NCT00860405

Voluven® in Paediatric Patients

A Phase 4 study testing HES 130/0.4 (6%) in sodium chloride (Voluven®, solution for infusion), Human serum albumin (HSA 50g/L) and Human serum albumin (HSA 50g/L) in people with Cardiac Surgery and Cardiopulmonary Bypass, run by Fresenius Kabi at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 2 to 12 years
Conditions the study is for: Cardiac Surgery, Cardiopulmonary Bypass
What is being tested?: HES 130/0.4 (6%) in sodium chloride (Voluven®, solution for infusion), Human serum albumin (HSA 50g/L) and Human serum albumin (HSA 50g/L)
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 61 participants
Where: 2 sitesin 2 countries
Study dates: Mar 2009to Dec 2010
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 2 to 12 years
All sexes
No healthy volunteers
Child

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

2 sites in 2 countries.

Country

City, postcode or hospital

2 sites in 2 countries

Austria1 site

AKh Allgemeines Krankenhaus der Stadt Linz GmbH
Linz, 4021

Other trials in Austria

Belgium1 site

HUDERF - Hôpital Universitaire des Enfants Reine Fabiola
Brussels, 1020

Other trials in Belgium

About this study

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

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

Read the 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.

Conditions: Cardiac Surgery, Cardiopulmonary Bypass
Being tested: HES 130/0.4 (6%) in sodium chloride (Voluven®, solution for infusion), Human serum albumin (HSA 50g/L), Human serum albumin (HSA 50g/L)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT00860405
Study group	Role	What they receive
1	Experimental	Investigational drug: HES 130/0.4 (6%) in sodium chloride (Voluven®, solution for infusion) Receives: Drug: HES 130/0.4 (6%) in sodium chloride (Voluven®, solution for infusion), Human serum albumin (HSA 50g/L)
2	Active comparator	Control drug: Human serum albumin (HSA 50g/L) Receives: Drug: Human serum albumin (HSA 50g/L)

What is being measured

The primary outcome is the main question the study is designed to answer.

Total Volume of Colloid Solution Required Intraoperatively
Total volume of study drug plus rescue colloid, if applicable
Measured: Day 1 (intraoperatively)

Secondary outcomes (4)

Mean Arterial Pressure (MAP)
Mean arterial pressure (MAP) from beginning of anaesthesia (baseline) until arrival on intensive care unit (ICU)
Measured: Beginning of anaesthesia (baseline) until arrival on intensive care unit (ICU)
Fluid Input
Quantity of total fluids administered from beginning of anaesthesia until 2nd postop morning
Measured: 2 days
Fluid Output
Quantity of total fluids excreted or lost from beginning of anaesthesia until 2nd postop morning
Measured: 2 days
Fluid Balance
Balance of total fluid input and total fluid output
Measured: 2 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2009Dec 2010

First posted12 Mar 2009 (estimated)
Study startMar 2009
Primary completionAug 2010
Study completionDec 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Cardiac SurgeryStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 61 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00860405
Sponsor's protocol ID: HE06-001-C P4
Status last verified: Oct 2011
First submitted: 27 Feb 2009
Last updated: 2 Nov 2011
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Cardiac Surgery trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00860405
Acronym / sponsor ID: HE06-001-C P4
Conditions: Cardiac Surgery, Cardiopulmonary Bypass
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 61 participants (actual)
Lead sponsor: Fresenius KabiIndustry (pharma, biotech, devices)
Study start: Mar 2009
Primary completion: Aug 2010 (actual)
Study completion: Dec 2010 (actual)
First posted: 12 Mar 2009 (estimated)
Results: Posted 19 Sep 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

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

Who may qualify

Ages: 2 to 12 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (2 listed)

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

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
HES 130/0.4 (6%) in sodium chloride (Voluven®, solution for infusion), Human serum albumin (HSA 50g/L)Also: Voluven®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.	Drug	1
Human serum albumin (HSA 50g/L)Human serum albumin (HSA 50g/L)	Drug	2

Primary outcome

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

4 secondary outcomes

Mean Arterial Pressure (MAP)
Time frame: Beginning of anaesthesia (baseline) until arrival on intensive care unit (ICU)
Fluid Input
Time frame: 2 days
Fluid Output
Time frame: 2 days
Fluid Balance
Time frame: 2 days

Results and safety

Results posted to the registry on 19 Sep 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Voluven® Arm	31	26
HSA 5% Arm (Comparison Group)	30	26

Primary outcome: Total Volume of Colloid Solution Required Intraoperatively

Time frame: Day 1 (intraoperatively). Mean (Standard Deviation). Unit: ml/kg

Measure	Voluven® Arm n = 29	HSA 5% Arm (Comparison Group) n = 26
Value	36.6 (11.76)	36.97 (11.86)

Voluven® Arm vs HSA 5% Arm (Comparison Group): Ratio of LS-means: 0.98 (95% CI 0.84 to 1.16), ANOVA

Population analysed: Per-protocol population (PP) = All patients in the Intention-to-treat (ITT) set without any major protocol violation.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Voluven® Arm	11 of 31 (35.5%)	30 of 31 (96.8%)	Not reported
HSA 5% Arm (Comparison Group)	7 of 29 (24.1%)	29 of 29 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Cardiac Surgery

Recruiting
ARTIST: Aortic Regurgitation Trial Investigating Surgery Versus Trilogy™
Aortic Regurgitation, Aortic Valve Insufficiency
RecruitingPhase 4
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Postoperative Delirium
Not yet recruiting
Randomized Evaluation of Operating Room Extubation After Cardiac Surgery
Cardiac Surgery
Not yet recruitingObservational study
Biomarkers of Postoperative Complications After Cardiac Surgery
Postoperative Complications
Active, not recruitingPhase 2/3
Equivalence of Oral Melatonin and Oral Midazolam in Preoperative Anxiolysis for Pediatric Fast-Track Cardiac Surgery
Comparative Effectiveness

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Philippe Van der Linden, Professor principal investigator

HUDERF - Hôpital Universitaire des Enfants Reine Fabiola

Hans Gombotz, Professor principal investigator

AKh Allgemeines Krankenhaus der Stadt Linz GmbH

2 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Austria, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Sep 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total Volume of Colloid Solution Required Intraoperatively (time frame: Day 1 (intraoperatively)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00860405.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2011.