Study to Evaluate the Safety of Kedbumin 25% Versus Normal Saline in the Treatment of Post-Surgical Hypovolemia in Pediatric Patients
Information source: Kedrion S.p.A.
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypovolemia
Intervention: Kedbumin 25% (Drug)
Phase: Phase 2/Phase 3
Status: Not yet recruiting
Sponsored by: Kedrion S.p.A.
Sue Bhadare, Phone: 540-428-2828, Email: email@example.com
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%.
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 design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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.
Minimum age: N/A.
Maximum age: 12 Years.
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.
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
12. Subject has participated in another clinical study within 30 days prior to study
Locations and Contacts
Sue Bhadare, Phone: 540-428-2828, Email: firstname.lastname@example.orgAdditional Information
Starting date: September 2012
Last updated: February 10, 2012