UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052933 |
|---|---|
| Receipt number | R000060390 |
| Scientific Title | Investigation of the efficacy of cardiopulmonary bypass method with blood delivery via femoral artery cannulation for pediatric aortic arch repair |
| Date of disclosure of the study information | 2023/11/28 |
| Last modified on | 2025/05/30 20:13:52 |
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Basic information
Public title
Investigation of the efficacy of cardiopulmonary bypass method with blood delivery via femoral artery cannulation for pediatric aortic arch repair
Acronym
Investigation of the efficacy of cardiopulmonary bypass method with blood delivery via femoral artery cannulation for pediatric aortic arch repair
Scientific Title
Investigation of the efficacy of cardiopulmonary bypass method with blood delivery via femoral artery cannulation for pediatric aortic arch repair
Scientific Title:Acronym
Investigation of the efficacy of cardiopulmonary bypass method with blood delivery via femoral artery cannulation for pediatric aortic arch repair
Region
| Japan | Europe |
Condition
Condition
Pediatric patients with congenital cardiovascular disease who underwent aortic arch repair
Classification by specialty
| Vascular surgery | Anesthesiology | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate whether the cardiopulmonary bypass (CPB) management with retrograde descending aortic perfusion via a femoral artery cannulation is as safe and effective as the CPB management with antegrade descending aortic perfusion under mild hypothermia and whether it is superior to the CPB management with circulatory arrest of the descending aorta under ultra-hypothermia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
This study investigates the degree of elevation of lactate levels in arterial blood gas measurements during CPB management.
Key secondary outcomes
This study compares urine output during CPB management.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| 18 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Pediatric patient with congenital cardiovascular disease who underwnet aortic arch repair
Key exclusion criteria
patients who underwent to "Re-Pump" (=CPB managements more than once in a surgery)
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Tomohiro |
| Middle name | |
| Last name | Yamamoto |
Organization
Niigata University Graduate School of Medical and Dental Sciences
Division name
Division of Anaesthesiology
Zip code
951-8510
Address
1-757, Asahimachi-dori, Chuo ward, Niigata
TEL
+81252272328
yamatomo@med.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomohiro |
| Middle name | |
| Last name | Yamamoto |
Organization
Niigata University Graduate School of Medical and Dental Sciences
Division name
Division of Anaesthesiology
Zip code
951-8510
Address
1-757, Asahimachi-dori, Chuo ward, Niigata
TEL
+81252272328
Homepage URL
yamatomo@med.niigata-u.ac.jp
Sponsor or person
Institute
Niigata University Graduate School of Medical and Dental Sciences
Institute
Department
Personal name
Tomohiro Yamamoto
Funding Source
Organization
Niigata University Graduate School of Medical and Dental Sciences
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee at Niigata University Graduate School of Medical and Dental Sciences
Address
1-757, Asahimachi-dori, Chuo ward, Niigata
Tel
+81-25-227-2625
ethics@adm.niigata-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 11 | Month | 28 | Day |
Related information
URL releasing protocol
https://link.springer.com/article/10.1007/s44253-024-00049-y
Publication of results
Partially published
Result
URL related to results and publications
https://link.springer.com/article/10.1007/s44253-024-00049-y
Number of participants that the trial has enrolled
74
Results
The minimum body temperatures during CPB were 16.79 degrees celsius, 23.73 degrees celsius, and 30.59 degrees celsius in Groups A, F, and D, respectively. The increases in lactate levels during CPB in Group F (1.06 mmol/L) were significantly lower than in Group A (1.66 mmol/L, p = 0.033); however, no different from Group D (0.92 mmol/L, p = 0.807).
Results date posted
| 2025 | Year | 05 | Month | 30 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
This study included patients who underwent paediatric aortic arch repairs between March 2012 and March 2018 at the German Paediatric Heart Centre, Sankt Augustin. Patients who were repumped intraoperatively were excluded. Group A (lower body circulatory arrest), Group F (retrograde aortic perfusion via femoral artery cannulation), and Group D (antegrade descending aortic perfusion) included 41, 18, and 15 patients, respectively.
Participant flow
This study included patients who underwent paediatric aortic arch repairs between March 2012 and March 2018 at the German Paediatric Heart Centre, Sankt Augustin. Patients who were repumped intraoperatively were excluded. Group A (lower body circulatory arrest), Group F (retrograde aortic perfusion via femoral artery cannulation), and Group D (antegrade descending aortic perfusion) included 41, 18, and 15 patients, respectively.
Adverse events
None
Outcome measures
The CPB records were retrospectively reviewed for the minimum body temperature during CPB (degrees celsius), lactate levels before CPB (mmol/L), CPB duration (min), aortic clamp time duration (min), total urine output (mL) and changes in lactate levels during CPB (mmol/L).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2012 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
German Pediatric Heart Centre Sankt Augustin/Asklepios Klinik Sankt Augustin, Sankt Augustin, Germany
Management information
Registered date
| 2023 | Year | 11 | Month | 28 | Day |
Last modified on
| 2025 | Year | 05 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060390
