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

NCT01531803 | Terminated Phase 4 Results DMC

• 1 other identifier: KB058
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 2

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.

Conditions

Hypovolemia

Outcome Measures

Primary Outcomes (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.

  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.

  3 days

Secondary Outcomes (2)

• Resolution of Hypovolemia With Adequate Fluid Resuscitation and Restoration of Hemodynamic Stability After Treatment With Kedbumin 25% Compared to Normal Saline Within 72 Hours.

  3 days

• Incidence, Severity and Seriousness of Expected and Unexpected AEs After Treatment With Kedbumin 25% Compared to Normal Saline.

  30 days

Study Arms (2)

Kedbumin 25%

EXPERIMENTAL

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%

Normal Saline Solution

PLACEBO COMPARATOR

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

Interventions

Kedbumin 25% DRUG

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).

Also known as: Albumin (Human) 25%

Kedbumin 25%

Normal Saline Solution DRUG

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.

Also known as: Normal (0.9%) saline solution

Normal Saline Solution

Eligibility Criteria

• Age: Up to 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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.

Sponsors & Collaborators

• Kedrion S.p.A.: lead
• inVentiv Health Clinical: collaborator

Study Sites (2)

Kosair Charities Pediatric Unit

Louisville, Kentucky, 40202, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Hypovolemia

Interventions

Albumins; Saline Solution

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Proteins; Amino Acids, Peptides, and Proteins; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Dr. Mirella Calcinai, MD, Clinical Research Director
• Organization: Kedrion S.p.A

m.calcinai@kedrion.com

+393486559761

Study Officials

• Mirella Calcinai, MD

  Kedrion SpA

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2012
• First Posted: February 13, 2012
• Study Start: February 5, 2015
• Primary Completion: July 15, 2015
• Study Completion: July 15, 2015
• Last Updated: November 15, 2023
• Results First Posted: February 18, 2021

Record last verified: 2023-10

Locations

US (2)