Safety Study of Kedbumin 25% Versus Normal Saline in the Treatment of Post-Surgical Hypovolemia in Pediatric Patients
Condition: Hypovolemia
MeSH terms: Hypovolemia
Intervention: Kedbumin 25%; Normal Saline Solution
Intervention description: 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).; 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.
Intervention MeSH terms: Pharmaceutical Solutions
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 3.0
Sex: All
Maximum age: 12 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female aged 0 days to 12 years, inclusive:

               -  (0 to 28 days);

               -  (29 days to 23 months);

               -  (2 to 5 years 11 months);

               -  (6 to 12 years).

          2. Subjects undergoing elective cardiac, abdominal, orthopedic, or transplant surgery.

          3. Subjects with a clinical diagnosis of hypovolemia developed within 24 hours from the
             completion of surgery, as judged by the Investigator.

          4. Admitted to ICU or acute care floor for post-operative recovery and care, in
             relatively stable condition.

          5. Subject, parent or guardian agrees to comply with the requirements of the protocol.

          6. Subject, parent or guardian has signed an informed consent form (ICF) and a child
             assent form if appropriate.

          7. Subject, parent or guardian has signed the Health Insurance Portability and
             Accountability Act (HIPAA) authorization.

        Exclusion Criteria:

          1. Intra-operative blood loss > 50 mL/kg.

          2. Severe hypoalbuminemia with serum albumin levels < 1g/dL.

          3. Known intolerance or allergy to albumin and/or plasma proteins.

          4. Preterm neonates, defined as neonates with a gestational age of <37 weeks (this
             criteria would only affect the 0-28 days group).

          5. Burn and trauma patients.

          6. Renal surgery.

          7. Subjects with acute CNS injury or trauma would be excluded from the study.

          8. Chronic renal insufficiency or acute renal failure (creatinine > 1.5 of normal value
             or based on age-appropriate renal function parameters), or a history of renal
             transplantation.

          9. Subjects with hypernatremia, defined as a Na level of ≥ 155 mEq/L.

         10. Severe congestive heart failure (CHF) using one of the following classification
             systems: Ross Heart Failure Classification, modified Ross Heart Failure
             Classification, or New York University Pediatric Heart Failure Index (NYU PHFI).

         11. Any concurrent medical, surgical or psychiatric condition that may, in the
             Investigator's opinion, affect the subject's ability to meet the protocol
             requirements.

         12. Subject has participated in another interventional clinical study within 30 days prior
             to study enrollment. Subjects who are participating in another observational study are
             not excluded.