Clinical Trial: Study to Evaluate the Safety of Kedbumin 25% Versus Normal Saline in the Treatment of Post-Surgical Hypovolemia in Pediatric Patients

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: A Prospective, Randomized, Multi-Center, Controlled, Open-Label Study to Evaluate the Safety of Kedbumin 25% Compared to Normal Saline Solution in the Treatment of Post-Surgical

Brief Summary:

This is a randomized, controlled, open-label clinical trial to be conducted at approximately 12 surgical and pediatric intensive care units (SICU/NICU/PICU) in the US, over a period of 22 months, with 6 months for trial set-up, 12 months of simultaneous subject enrollment and 30 days of treatment/follow-up period, and 3 months for study close-out.

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.

Regarding the youngest age group of 0 to 28 days, the minimum number of patients to be enrolled in the study will not be predefined as very a small number of elective surgical procedures is expected in this population.

Safety concerns and eventual safety signals, as well as recruitment rate, will be monitored annually (starting from the enrollment of the 60th subject) by an independent Safety Monitoring Board (SMB), which will be appointed prior to study initiation and submitted to the FDA. The responsibilities of the SMB will be defined in ad hoc document, in which the threshold for acceptable safety will also be set.

During the conduct of the study on the first 60 patients, if there is any safety signal linked to the primary safety endpoint (i.e. pulmonary fluid overload) or imbalance in the incidence of AEs between the treatment and control groups or based on relevant literature, as judged by the SMB, the enrolment will be increased to 100 patients using the same age stratification approach defined above (n=20 to 30 in each

Detailed Summary:
Sponsor: Kedrion S.p.A.

Current Primary Outcome: Incidence, Severity, and Seriousness of Fluid Overload and Edema (Pulmonary Portal or Systemic) and/or Other Complications Secondary to Fluid Resuscitation with Kedbumin 25% Compared to Normal Saline. [ Time Frame: 3 days ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Kedrion S.p.A.

Dates:
Date Received: February 1, 2012
Date Started: September 2012
Date Completion:
Last Updated: October 22, 2015
Last Verified: October 2015