NCT03576534: PBUF

Pre Bypass Ultrafiltration (PBUF) in Children Requiring Cardiopulmonary Bypass

Terminated NA Last updated 2 March 2022

What this trial tests

NA trial testing Use of prebypass ultrafiltration (PBUF) in Congenital Heart Disease in 13 participants. Terminated before completion.

Timeline

3 October 2019

Primary endpoint
13 September 2021

13 September 2021

Quick facts

Lead sponsor	Boston Children's Hospital
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	13
Start date	3 October 2019
Primary completion	13 September 2021
Estimated completion	13 September 2021
Sites	1 location across United States

Drugs / interventions tested

• Use of prebypass ultrafiltration (PBUF)

Conditions studied

• Congenital Heart Disease — all drugs for Congenital Heart Disease →

Sponsor

Boston Children's Hospital

Who can join

Adults 1 Day to 1, any sex, with Congenital Heart Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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 difference to how subjects recover after surgery. The investigators believe that providing more normal blood values will either improve the subjects' outcome or have no benefit. The investigators do not anticipate increased risks.

Given COVID -19 restrictions, the study is on hold.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.