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

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ClinicalTrials.gov 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
Results First Posted : February 18, 2021
Last Update Posted : February 18, 2021
Sponsor:
Collaborator:
inVentiv Health Clinical
Information provided by (Responsible Party):
Kedrion S.p.A.

Brief 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.

Condition or disease Intervention/treatment Phase
Hypovolemia Drug: Kedbumin 25% Drug: Normal Saline Solution Phase 4

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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, Multicenter, Controlled, Open-Label Study to Evaluate the Safety of Kedbumin25% Compared to Normal Saline Solution in the Treatm. of PostSurgical Hypovolemia in Pediatric Patients Undergoing Major Elective Surgery
Actual Study Start Date : February 5, 2015
Actual Primary Completion Date : July 15, 2015
Actual Study Completion Date : July 15, 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Safety

Arm Intervention/treatment
Experimental: Kedbumin 25%

Albumin (Human) 25% solution for intravenous (IV) infusion in the dosage strength of 250g/L human albumin, 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). The duration of treatment is based on the subject's response to treatment until hemodynamic stability is achieved. If hemodynamic stability is not achieved within 72 hours of starting the study treatment, the subject will be withdrawn from the study and will be treated according to standard practice and data collected during the study period will be used for the safety evaluation.

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).

Other Name: Albumin (Human) 25%

Placebo Comparator: Normal Saline Solution
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.
Drug: Normal Saline Solution
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.
Other Name: Normal (0.9%) saline solution




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 ]

    Criteria for Primary Evaluation:

    1. Presence of rales at pulmonary bases: cut-off YES/NO and at least one of the following:

      • Chest X Ray: presence of Kerley B lines: cut-off YES/NO;
      • Doppler sonography to measure the pulmonary artery pressure: cut-off >20mmHg;
      • Arterial oxygen saturation: cut-off ≤ 90% and/or ABG: cut-off pO2 ≤ 70mmHg.
    2. Fluid overload and edema is quantified by % increase in body weight over the subject's preoperative weight stratified by <10%, 11-15%, 16-20% and >20%.
    3. Physical examination for edema.

    All the measurements for the assessment of the safety parameters will be collected, reviewed, and recorded by research staff until hemodynamic stability is achieved.



Secondary Outcome Measures :
  1. Resolution of Hypovolemia With Adequate Fluid Resuscitation and Restoration of Hemodynamic Stability After Treatment With Kedbumin 25% Compared to Normal Saline Within 72 Hours. [ Time Frame: 3 days ]

    The secondary safety parameter of resolution of hypovolemia and adequate fluid resuscitation will be evaluated based on the following indicators:

    • Hemodynamic status [heart rate (HR), blood pressure (BP), urine output (UOP)];
    • Tissue hypoperfusion [lactate levels, base deficit derived from arterial blood gas, if arterial line is in place] or determined by the use of a pulse oximetry;
    • Electrolyte status [Na+, Ca++, Mg++, K+, Cl- ,PO4];
    • Renal/hepatic function [urine albumin, blood urea nitrogen (BUN), creatinine, creatinine clearance, total bilirubin, ALT, AST, Albumin, Alkaline Phosphatase (ALP), gamma glutamyltransferase (GGT)];
    • Complete blood count (CBC);
    • Partial Thromboplastin Time/ International Normalized Ratio (PTT/INR).

    All the measurements for the assessment of the safety parameters will be collected, reviewed, and recorded by research staff until hemodynamic stability is achieved.


  2. Incidence, Severity and Seriousness of Expected and Unexpected AEs After Treatment With Kedbumin 25% Compared to Normal Saline. [ Time Frame: 30 days ]

    The severity, seriousness, and relatedness of AEs to the study drug will be observed on repeated administrations of the study drug.

    Subjects will be carefully monitored by the SICU/NICU/PICU or acute care floor staff for expected and unexpected AEs which occur from the time of dosing to 30 days post dose.

    If the subject is discharged prior to 30 days, research staff will collect AEs at follow-up visits and via spontaneous reporting by the subject.




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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01531803


Locations
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United States, Kentucky
Kosair Charities Pediatric Unit
Louisville, Kentucky, United States, 40202
United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Kedrion S.p.A.
inVentiv Health Clinical
Investigators
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Study Director: Mirella Calcinai, MD Kedrion SpA
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Responsible Party: Kedrion S.p.A.
ClinicalTrials.gov Identifier: NCT01531803    
Other Study ID Numbers: KB058
First Posted: February 13, 2012    Key Record Dates
Results First Posted: February 18, 2021
Last Update Posted: February 18, 2021
Last Verified: January 2021
Additional relevant MeSH terms:
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Hypovolemia
Pathologic Processes
Pharmaceutical Solutions