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NCT03576534 · ClinicalTrials.gov registry record · NA
Pre Bypass Ultrafiltration (PBUF) in Children Requiring Cardiopulmonary Bypass
A NA study, sponsored by Boston Children's Hospital.
- Terminated
- Registry status
- NA
- Development phase
- 13
- Enrollment target
NCT03576534 is a NA study that was terminated before completion, run by Boston Children's Hospital. The registered enrollment target is 13 participants.
The verdict
NCT03576534, a NA study, was terminated before completion, sponsored by Boston Children's Hospital.
- TERMINATED
- Registry status
- NA
- Development phase
- 13 participants
- Enrollment target
Study Summary
Newborn babies and children with congenital heart defects who need heart surgery need to be placed on the heart-lung machine for heart surgery. In order to use the heart-lung machine, the investigators have to use blood and other fluids to fill the tubing. During the operation, ultrafiltration is carried out as standard of care to remove extra fluid. Modified ultrafiltration is also performed after surgery. In this study, the investigators are looking to use the filter additionally before surgery. Using the pre bypass filtration before the subject is placed on the heart-lung machine will allow the investigators to better normalize electrolytes in the blood/fluid mixture used in the heart lung machine. This technique is called pre-bypass ultrafiltration, or PBUF (pronounced "P" Buff). The investigators are conducting a study to see if using PBUF to better normalize electrolytes in the blood will make a difference. The investigators have been adding fluids to prime the heart-lung machine in two different ways. The investigators believe both methods are safe and acceptable but hypothesize that there may be subtle differences in electrolytes and fluid status when one technique is used as opposed to the other. The investigators believe that neither technique introduces risk since both are currently used in practice. The standard method adds blood to the heart-lung machine. The alternate method adds blood to the heart-lung machine and then additional fluid is added and removed to more normalize the electrolytes. The investigators plan to randomized subjects undergoing heart surgery to receive the standard priming method versus PBUF to determine if there is any difference in outcomes. Laboratory and clinical data collected as part of clinical care will be used to determine difference sin outcomes. There will be no additional blood taken for this study. There are no known risks to PBUF. The benefits include helping investigators determine if PBUF does or does not make a
Interventions
- OTHER Use of prebypass ultrafiltration (PBUF)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2019-10-03 |
| Est. Completion | 2021-09-13 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03576534
The ClinicalTrials.gov registry entry for NCT03576534 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 13 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boston Children's Hospital, which has 462 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Use of prebypass ultrafiltration (PBUF) is the first listed.
NCT03576534 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03576534 about?
NCT03576534 is a clinical study titled "Pre Bypass Ultrafiltration (PBUF) in Children Requiring Cardiopulmonary Bypass". Newborn babies and children with congenital heart defects who need heart surgery need to be placed on the heart-lung machine for heart surgery. In order to use the heart-lung machine, the investigators have to use blood and other fluids to fill the tubing. During the operation, ultrafiltration is c...
What is the current status of trial NCT03576534?
This trial is currently terminated. It is a NA study. The enrollment target is 13 participants. The study started on 2019-10-03. Estimated completion is 2021-09-13.
What interventions are being tested in trial NCT03576534?
The interventions under investigation include: Use of prebypass ultrafiltration (PBUF) (OTHER).
Who is sponsoring clinical trial NCT03576534?
This trial is sponsored by Boston Children's Hospital, which has 462 total clinical trials registered on ClinicalTrials.gov.
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