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Kedbumin 25% vs Normal Saline in Pediatric Post-Surgical Hypovolemia
NCT01531803Phase 4
Key facts
- Status
- Terminated
- Start
- Feb 2015
- Primary completion
- Jul 2015
- Countries
- 1
- Sponsor
- Kedrion Biopharma
- Modality
- Recombinant Proteins and Enzymes
- Drugs
- Kedbumin
- Conditions
- hypovolemia
01
Overview
Phase 4, randomised, open-label trial of Kedbumin in hypovolemia (2 arms), sponsored by Kedrion Biopharma. Primary endpoint: Incidence, Severity, and Seriousness of Fluid Overload and Edema at 3 days. Started Feb 2015; status: terminated.
02
Design
2 arms- Study design
- RandomizedOpen-label
Kedbumin 25%
Albumin (Human) 25% solution IV
Normal Saline Solution
Normal (0.9%) saline solution IV
03
Who it enrols
Pediatric patients (0-12 years) undergoing major elective surgery who develop hypovolemia within 24 hours post-surgery, excluding preterm neonates and those with severe renal or cardiac conditions.
04
Endpoints
Primary
Incidence, Severity, and Seriousness of Fluid Overload and Edema
Secondary
Resolution of Hypovolemia With Adequate Fluid Resuscitation and Restoration of Hemodynamic Stability
Incidence, Severity and Seriousness of Expected and Unexpected AEs
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