Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01531803 · ClinicalTrials.gov registry record · Phase 4
Safety Study of Kedbumin 25% Versus Normal Saline in the Treatment of Post-Surgical Hypovolemia in Pediatric Patients
A Phase 4 study, sponsored by Kedrion S.p.A..
- Terminated
- Registry status
- Phase 4
- Development phase
- 3
- Enrollment target
NCT01531803: Clinical Trial Phase 4 study, sponsored by Kedrion S.p.A..
NCT01531803 is a Phase 4 study that was terminated before completion, run by Kedrion S.p.A.. The registered enrollment target is 3 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01531803, a Phase 4 study, was terminated before completion, sponsored by Kedrion S.p.A..
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 3 participants
- Enrollment target
Study 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.
Primary Outcome
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% a
Interventions
- DRUG Normal Saline Solution
- DRUG Kedbumin 25%
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2015-02-05 |
| Est. Completion | 2015-07-15 |
| Phase | Phase 4 |
Why NCT01531803 stopped before completion
NCT01531803 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which Normal Saline Solution is the first listed.
NCT01531803 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01531803 about?
NCT01531803 is a clinical study titled "Safety Study of Kedbumin 25% Versus Normal Saline in the Treatment of Post-Surgical Hypovolemia in Pediatric Patients". 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 pedi...
What is the current status of trial NCT01531803?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 3 participants. The study started on 2015-02-05. Estimated completion is 2015-07-15.
What interventions are being tested in trial NCT01531803?
The interventions under investigation include: Normal Saline Solution (DRUG), Kedbumin 25% (DRUG).
Who is sponsoring clinical trial NCT01531803?
This trial is sponsored by Kedrion S.p.A., which has 8 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01531803's enrollment target sits among peer trials
3 1995th of 2000 higher than 3 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI