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

Stopped early · Phase 4

Conditions studied: Hypovolemia

In brief

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.

Key facts

Study ID

NCT01531803

Run by

Kedrion S.p.A.

People needed

3

Starts

2015-02-05

Expected to finish

2015-07-15

Last updated by the study team

2023-11-15

Who can join

Age: any, up to 12. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).
• Subjects undergoing elective cardiac, abdominal, orthopedic, or transplant surgery.
• Subjects with a clinical diagnosis of hypovolemia developed within 24 hours from the completion of surgery, as judged by the Investigator.
• Admitted to ICU or acute care floor for post-operative recovery and care, in relatively stable condition.
• Subject, parent or guardian agrees to comply with the requirements of the protocol.
• Subject, parent or guardian has signed an informed consent form (ICF) and a child assent form if appropriate.
• Subject, parent or guardian has signed the Health Insurance Portability and Accountability Act (HIPAA) authorization.

You may not qualify if…

• Intra-operative blood loss > 50 mL/kg.
• Severe hypoalbuminemia with serum albumin levels < 1g/dL.
• Known intolerance or allergy to albumin and/or plasma proteins.
• Preterm neonates, defined as neonates with a gestational age of <37 weeks (this criteria would only affect the 0-28 days group).
• Burn and trauma patients.
• Renal surgery.
• Subjects with acute CNS injury or trauma would be excluded from the study.
• 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.
• Subjects with hypernatremia, defined as a Na level of ≥ 155 mEq/L.
• 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).
• Any concurrent medical, surgical or psychiatric condition that may, in the Investigator's opinion, affect the subject's ability to meet the protocol requirements.
• 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.

Where it is running

• Kosair Charities Pediatric Unit — Louisville, Kentucky, United States
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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