Under 12, any sex, with Hypovolemia. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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.Primary· 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
Group
Value
95% CI
Kedbumin 25%
0
Normal Saline Solution
0
Resolution of Hypovolemia With Adequate Fluid Resuscitation and Restoration of Hemodynamic Stability After Treatment With Kedbumin 25% Compared to Normal Saline Within 72 Hours.Secondary· 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 Ph
Group
Value
95% CI
Kedbumin 25%
0
Normal Saline Solution
0
Incidence, Severity and Seriousness of Expected and Unexpected AEs After Treatment With Kedbumin 25% Compared to Normal Saline.Secondary· 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.
Group
Value
95% CI
Kedbumin 25%
0
Normal Saline Solution
1
Adverse events — posted to ClinicalTrials.gov
Time frame: 30 days.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Kedrion S.p.A.
Last refreshed: 15 November 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01531803.