Safety Study of Kedbumin 25% Versus Normal Saline in the Treatment of Post-Surgical Hypovolemia in Pediatric Patients

PHASE4TerminatedINTERVENTIONAL
Enrollment

3

Participants

Timeline

Start Date

February 5, 2015

Primary Completion Date

July 15, 2015

Study Completion Date

July 15, 2015

Conditions
Hypovolemia
Interventions
DRUG

Kedbumin 25%

"Albumin (Human) 25% solution for intravenous (IV) infusion in the dosage strength of 250g human albumin /L, supplied in 50 mL type II vial (each vial containing 12.5g human albumin).~The dose will be 0.5 to 1g/kg body weight (2 to 4 mL/kg of 25% albumin)."

DRUG

Normal Saline Solution

Normal (0.9%) saline solution administered via IV infusions of 10 to 20 mL/kg as appropriate per standard of care based on the subject's clinical status and response to treatment.

Trial Locations (2)

40202

Kosair Charities Pediatric Unit, Louisville

53226

Medical College of Wisconsin, Milwaukee

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

inVentiv Health Clinical

OTHER

lead

Kedrion S.p.A.

INDUSTRY