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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01531803
Recruitment Status : Terminated (Per FDA CBER letter dated July 15, 2015, Kedrion SpA was released from the PMC to perform the study with Kedbumin 25 % in pediatric patients)
First Posted : February 13, 2012
Last Update Posted : October 23, 2015
inVentiv Health Clinical
Information provided by (Responsible Party):
Kedrion S.p.A.

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 age group).

Potential subjects will be pre-screened and informed consent/assent will be obtained from the subject and/or subject's parents or guardians prior to surgery. Post-surgery, the subject will be admitted to the Surgical, Neonatal, or Pediatric Intensive Care Unit (SICU/NICU/PICU) for postoperative recovery and care management. Subjects who show signs of hypovolemia as judged by the Principal Investigator (PI) will be screened to determine their eligibility to participate in this trial. Subjects will then be randomized to receive treatment with Kedbumin 25% or the comparator, normal saline (sodium chloride 0.9%).

There is no specific post-treatment regimen for this protocol, as all subjects will receive the standard post-operative care based on their clinical status and response to treatment at the discretion of the Investigator.

Vital signs and fluid management/replacement therapy recorded in the medical chart and results of standard complete blood count (CBC), biochemistry, and hematology and coagulation lab panels will be reviewed and recorded by research staff at specified time points, according to the hospital standard of care. Additionally, research staff will review and record daily lactate, urine albumin, blood urea nitrogen (BUN), creatinine, and non-invasive measurements at the following time points: Baseline, 6hr, 12hr, 24hr, 36hr, 48hr, and 72hr post-onset of hypovolemia), until hemodynamic stability is achieved. Hemodynamic stability will be evaluated based on site-specific age-defined reference ranges for heart rate, blood pressure, urine output, and cardiac index in children.

The volume, rate and frequency of the Investigational Medicinal Product (IMP, either Kedbumin 25% or normal saline) administered will be recorded in addition to the type, timing, and amount of all other fluids administered. The time to hemodynamic stability, duration of stability once attained, and any relapse requiring additional treatment or use of secondary resuscitation strategies will be recorded. Subjects who demonstrate hemodynamic stability within 3 days after treatment initiation and then relapse into hemodynamic instability as a result of surgical complications or infection will exit from the study, but the data be considered for the safety analysis. These subjects should continue treatment according the clinical practice standard since the study is not intended to evaluate the efficacy of Kedbumin 25%.

Condition or disease Intervention/treatment Phase
Hypovolemia Drug: Kedbumin 25% Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Hypovolemia in Pediatric Patients Undergoing Major Elective Surgery.
Study Start Date : September 2012
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Kedbumin 25% 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).

Sham Comparator: Normal Saline 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).

Primary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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, as judged by the Investigator.
  4. Admitted to ICU for post-operative recovery and care, in relatively stable condition.
  5. Subject 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 > 40 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.
  5. Burn and trauma patients.
  6. Renal surgery.
  7. Cranial surgery, trauma and/or central nervous system (CNS) damage.
  8. Chronic renal insufficiency or acute renal failure (creatinine > 1.5 of normal value or based on age-appropriate renal function parameters).
  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 clinical study within 30 days prior to study enrollment.
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Responsible Party: Kedrion S.p.A. Identifier: NCT01531803    
Other Study ID Numbers: KB058
First Posted: February 13, 2012    Key Record Dates
Last Update Posted: October 23, 2015
Last Verified: October 2015
Additional relevant MeSH terms:
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Pathologic Processes