Congenital Heart DiseaseRAPCPBNCT04260204
Effect of Retrograde Autologous Blood Priming on Pulmonary Mechanics in Pediatric Cardiac Surgery
A study testing Pediatric cardiac surgery in people with Congenital Heart Disease, run by Ain Shams University.
Trial summary
The present study hypothesized that beyond its hemodynamic affects,retrograde autologus blood priming of cardiopulmonary bypass (RAP) has a positive impact on hemodynamics and pulmonary mechanics subjected to cardiac surgery. Read more about this study
- Who is it for?
- Ages 12 months to 5 years
- Conditions the study is for
- Congenital Heart Disease
- What is being tested?
- Pediatric cardiac surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- No sites listed yet
- Study dates
- 2 Jan 2015to 25 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 months to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children complained of congenital heart disease with left to right shunt pressure or volume load
Who cannot join
- cyanotic heart disease
About this study
Official title: Effect of Retrograde Autologous Blood Priming of Cardiopulmonary Bypass on Hemodynamic Parameters and Pulmonary Mechanics in Pediatric Cardiac Surgery
The present study hypothesized that beyond its hemodynamic affects,retrograde autologus blood priming of cardiopulmonary bypass (RAP) has a positive impact on hemodynamics and pulmonary mechanics subjected to cardiac surgery.
Read the detailed description
This prospective randomized study analyzed the clinical records of 124 children subjected to cardiac surgery for congenital heart diseases with left to right shunt. They comprised 64 patients with RAP and 60 patients conventional cardiopulmonary bypass priming. The preoperative, intraoperative and postoperative data of the studied patients were reported.
- Conditions
- Congenital Heart Disease
- Being tested
- Pediatric cardiac surgery
- Keywords
- retrograde autologous priming pulmonary mechanics
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pediatric cardiac surgeryProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Retrograde priming | Active comparator | retrograde autologous Blood Priming of Cardiopulmonary Bypass (RAP) in young children subjected to cardiac surgery for congenital heart defects with left to right shunt associated with volume or pressure overload. Receives: Procedure: Pediatric cardiac surgery |
| conventional priming | Active comparator | conventional cardiopulmonary priming in young children subjected to cardiac surgery for congenital heart defects with left to right shunt associated with volume or pressure overload. Receives: Procedure: Pediatric cardiac surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of postoperative peak air way pressure between the studied groups
peak air way pressure (Paw) in cmH2O
Measured: 1 hour after surgery
Comparison of postoperative air way resistance between the studied groups
air way resistance (Raw) in cmH2O/L/sec.
Measured: 1 hour after surgery
Comparison of postoperative Plateau pressure between the studied groups
Plateau pressure in cm H2O
Measured: 1 hour after surgery
Comparison of postoperative Lung compliance between the studied groups
Lung compliance in L/cm H2O
Measured: 1 hour after surgery
Comparison of postoperative Tidal volume between the studied groups
Tidal volume in ml
Measured: 1 hour after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2020
- Study start2 Jan 2015
- Primary completion30 Dec 2019
- Study completion25 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients were included in the study if they had left to right shunt due to volume or pressure overload
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Hamdy Singab, Ain Shams University
- Investigators
- Hamdy Singab, PhD, Principal investigator, Ain shams university faculty of medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04260204
- Sponsor's protocol ID
- ACTS004367
- Acronym
- RAPCPB
- Status last verified
- Mar 2020
- First submitted
- 1 Feb 2020
- Last updated
- 4 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Pulmonary mechanics improvement in pediatric patients undergoing cardiac surgery with retrograde autologous priming
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Retrograde Autologous Blood Priming of Cardiopulmonary Bypass on Hemodynamic Parameters and Pulmonary Mechanics in Pediatric Cardiac Surgery
- ClinicalTrials.gov ID
- NCT04260204
- Acronym / sponsor ID
- RAPCPB / ACTS004367
- Conditions
- Congenital Heart Disease
- Keywords
- retrograde autologous priming pulmonary mechanics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 2 Jan 2015 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 25 Jan 2020 (actual)
- First posted
- 7 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The present study hypothesized that beyond its hemodynamic affects,retrograde autologus blood priming of cardiopulmonary bypass (RAP) has a positive impact on hemodynamics and pulmonary mechanics subjected to cardiac surgery.
Detailed description
This prospective randomized study analyzed the clinical records of 124 children subjected to cardiac surgery for congenital heart diseases with left to right shunt. They comprised 64 patients with RAP and 60 patients conventional cardiopulmonary bypass priming. The preoperative, intraoperative and postoperative data of the studied patients were reported.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Patients were included in the study if they had left to right shunt due to volume or pressure overload
| Arm | Type | Receives |
|---|---|---|
| Retrograde priming | Active comparator | Procedure: Pediatric cardiac surgeryretrograde autologous Blood Priming of Cardiopulmonary Bypass (RAP) in young children subjected to cardiac surgery for congenital heart defects with left to right shunt associated with volume or pressure overload. |
| conventional priming | Active comparator | Procedure: Pediatric cardiac surgeryconventional cardiopulmonary priming in young children subjected to cardiac surgery for congenital heart defects with left to right shunt associated with volume or pressure overload. |
Who may qualify
- Ages
- 12 months to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- children complained of congenital heart disease with left to right shunt pressure or volume load
Key exclusion criteria (1 listed)
- cyanotic heart disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pediatric cardiac surgery | Procedure or surgery | Retrograde priming, conventional priming |
Primary outcome
Comparison of postoperative peak air way pressure between the studied groups
Time frame: 1 hour after surgery
peak air way pressure (Paw) in cmH2O
Comparison of postoperative air way resistance between the studied groups
Time frame: 1 hour after surgery
air way resistance (Raw) in cmH2O/L/sec.
Comparison of postoperative Plateau pressure between the studied groups
Time frame: 1 hour after surgery
Plateau pressure in cm H2O
Comparison of postoperative Lung compliance between the studied groups
Time frame: 1 hour after surgery
Lung compliance in L/cm H2O
Comparison of postoperative Tidal volume between the studied groups
Time frame: 1 hour after surgery
Tidal volume in ml
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2020.
- Individual participant dataSharing planned: Yes. Pulmonary mechanics improvement in pediatric patients undergoing cardiac surgery with retrograde autologous priming
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hamdy Singab, PhD principal investigator
Ain shams university faculty of medicine
Questions about this trial
What is this clinical trial studying?
A study testing Pediatric cardiac surgery in people with Congenital Heart Disease, run by Ain Shams University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of postoperative peak air way pressure between the studied groups (time frame: 1 hour after surgery). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2020.