Phase 4
Completed N=61
Voluven® in Paediatric Patients
Source: ClinicalTrials.gov NCT00860405 ↗Enrolled (actual)
61
Serious AEs
30.0%
Results posted
Sep 2011
Primary outcomePrimary: Total Volume of Colloid Solution Required Intraoperatively — 36.6; 36.97 ml/kg
Summary
This study will compare the clinical efficacy and safety of Voluven® and Human Albumin during elective open-heart surgery in pediatric patients.
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 | — |
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
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. Informational only — not medical advice.