Phase 4 N=61 Randomized Quadruple-blind Treatment

Voluven® in Paediatric Patients

Cardiac Surgery · Cardiopulmonary Bypass

Bottom Line

View on ClinicalTrials.gov: NCT00860405 ↗

Enrolled (actual)

Serious AEs

30.0%

Results posted

Sep 2011

Primary outcome: Primary: Total Volume of Colloid Solution Required Intraoperatively — 36.6; 36.97 ml/kg

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: 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) (Drug)
Age: Pediatric · 2+ yrs
Sex: All
Sponsor: Fresenius Kabi
Primary completion: Aug 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Total Volume of Colloid Solution Required Intraoperatively	36.6; 36.97	—
SECONDARY Mean Arterial Pressure (MAP)	64.1; 66.5; 54.0; 51.3; 56.6; 58.2	—
SECONDARY Fluid Input	246.8; 248.2	—
SECONDARY Fluid Output	195.5; 181.1	—
SECONDARY Fluid Balance	51.3; 67.1	—

Summary

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

Eligibility 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 III

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00860405). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.