Safety Study of Kedbumin 25% Versus Normal Saline in the Treatment of Post-Surgical Hypovolemia in Pediatric Patients
Status:
Terminated
Trial end date:
2015-07-15
Target enrollment:
Participant gender:
Summary
This is a randomized, controlled, open-label clinical trial aimed to evaluate the Safety of
Kedbumin 25% Compared to Normal Saline Solution in the Treatment of Post-Surgical Hypovolemia
in Pediatric Patients Undergoing Major Elective Surgery. It will be conducted at
approximately 5 surgical and pediatric intensive care units (SICU/NICU/PICU) in the US, over
a period of 19 months, and the study population will consist of at least 60 male and female
pediatric subjects between 0 days and 12 years of age, undergoing cardiac, abdominal,
orthopedic or transplant surgery with an approximately equal number of subjects (n=10 to 25)
in three of the four age groups: (29 days to 23 months), (2 to 5 years 11 months) and (6
years to 12 years) cohorts.