UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014188 |
|---|---|
| Receipt number | R000016165 |
| Scientific Title | Comparison of central venous to mixed venous oxygen saturation in pediatric cardiac surgery patients with post operative persistent pulmonary hypertension. |
| Date of disclosure of the study information | 2014/06/06 |
| Last modified on | 2014/06/06 14:44:33 |
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Basic information
Public title
Comparison of central venous to mixed venous oxygen saturation in pediatric cardiac surgery patients with post operative persistent pulmonary hypertension.
Acronym
Comparison of central venous to mixed venous oxygen saturation in pediatric cardiac surgery patients with post operative persistent pulmonary hypertension.
Scientific Title
Comparison of central venous to mixed venous oxygen saturation in pediatric cardiac surgery patients with post operative persistent pulmonary hypertension.
Scientific Title:Acronym
Comparison of central venous to mixed venous oxygen saturation in pediatric cardiac surgery patients with post operative persistent pulmonary hypertension.
Region
| Japan |
Condition
Condition
Congenital cardiac anomaly with two-ventricle circulation and pulmonary hypertension.
Classification by specialty
| Anesthesiology | Intensive care medicine | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to compare central venous to mixed venous oxygen saturation in congenital cardiac surgery patient with pulmonary hypertension.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
central venous and mixed venous oxygen saturation
Key secondary outcomes
Heart rate, arterial blood pressure, pulmonary arterial pressure, central venous pressure, body temperature, arterial blood gas analysis.
Base
Study type
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Blood samples are drawn simultaneously from the central venous catheter, pulmonary arterial catheter, and arterial pressure line every six hours in postoperative 24h, and then blood gas analysis of these samples is done.
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
| 1 | months-old | <= |
Age-upper limit
| 36 | months-old | >= |
Gender
Male and Female
Key inclusion criteria
Patient scheduled to repair congenital cardiac anomaly with pulmonary hypertension.
Two-ventricle circulation.
Pulmonary arterial pressure catheter.
Key exclusion criteria
Patient who has postoperative residual shunt.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Osamu Umegaki |
Organization
Osaka medical college
Division name
Department of anesthesiology, intensive care medicine
Zip code
Address
2-7 Daigaku-machi, Takatsuki, Osaka
TEL
+81-72-683-1221
oumegaki@poh.osaka-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yusuke Kusaka |
Organization
Osaka medical college
Division name
Department of anesthesiology, intensive care medicine
Zip code
Address
2-7 Daigaku-machi, Takatsuki, Osaka
TEL
+81-72-683-1221
Homepage URL
Y.kusaka1978@gmail.com
Sponsor or person
Institute
Department of anesthesiology and intensive care medicine
Institute
Department
Personal name
Funding Source
Organization
Department of anesthesiology and intensive care medicine
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
Address
Tel
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
| 2014 | Year | 06 | Month | 06 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2014 | Year | 01 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 06 | Month | 06 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 06 | Month | 06 | Day |
Last modified on
| 2014 | Year | 06 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016165
