UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037663 |
|---|---|
| Receipt number | R000042950 |
| Scientific Title | The association between intraoperative net fluid balance and postoperative atrial fibrillation recurrence after Maze procedure. |
| Date of disclosure of the study information | 2019/08/12 |
| Last modified on | 2021/06/04 21:11:36 |
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Basic information
Public title
The association between intraoperative net fluid balance and postoperative atrial fibrillation recurrence after Maze procedure.
Acronym
MAZE-fluid
Scientific Title
The association between intraoperative net fluid balance and postoperative atrial fibrillation recurrence after Maze procedure.
Scientific Title:Acronym
MAZE-fluid
Region
| Japan |
Condition
Condition
Atrial fibrillation
Classification by specialty
| Surgery in general | Operative medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigate the association between intraoperative net fluid balance and postoperative atrial fibrillation recurrence after Maze procedure.
Basic objectives2
Others
Basic objectives -Others
Investigate the association between intraoperative net fluid balance and postoperative atrial fibrillation recurrence after Maze procedure using multivariable logistic regression model.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Postoperative recurrence of atrial fibrillation and/or atrial flutter and/or supraventricular tachycardia.
Key secondary outcomes
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patient undergoing Maze procedure.
Key exclusion criteria
None.
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Kimito |
| Middle name | |
| Last name | Minami |
Organization
National cerebral and cardiovascular center
Division name
Department of surgical intensive care
Zip code
564-8565
Address
6-1 Kishibeshinmachi, Suita, Osaka
TEL
06-6170-1070
k.minami@ncvc.go.jp
Public contact
Name of contact person
| 1st name | Kimito |
| Middle name | |
| Last name | Minami |
Organization
National cerebral and cardiovascular center
Division name
Department of surgical intensive care
Zip code
564-8565
Address
6-1 Kishibeshinmachi, Suita, Osaka
TEL
06-6170-1070
Homepage URL
k.minami@ncvc.go.jp
Sponsor or person
Institute
National cerebral and cardiovascular center
Institute
Department
Personal name
Funding Source
Organization
National cerebral and cardiovascular center
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
National cerebral and cardiovascular center
Address
6-1 Kishibeshinmachi, Suita, Osaka
Tel
06-6170-1070
k.minami@ncvc.go.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
| 2019 | Year | 08 | Month | 12 | Day |
Related information
URL releasing protocol
https://www.jcvaonline.com/article/S1053-0770(20)31137-X/fulltext
Publication of results
Published
Result
URL related to results and publications
https://www.jcvaonline.com/article/S1053-0770(20)31137-X/fulltext
Number of participants that the trial has enrolled
444
Results
Multivariate logistic regression showed that intraoperative net fluid balance (p<0.001), preoperative AF duration (adjusted odds ratio, 1.40; 95% CI, 1.17-1.68; p < 0.001) and left atrial volume index (aOR,1.61; 95% CI, 1.06-2.45; p = 0.025) were independent predictors of early atrial tachyarrhythmia recurrence. The adjusted log odds were lowest(-1.52) when net fluid balance was 1,557 mL.
Results date posted
| 2020 | Year | 08 | Month | 10 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
patients s/p MAZE procedure
Participant flow
opt-out
Adverse events
none
Outcome measures
recurrent atrial tachyarrhyhmia
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2018 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 10 | Month | 24 | Day |
Anticipated trial start date
| 2018 | Year | 10 | Month | 24 | Day |
Last follow-up date
| 2019 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To assess the adjusted effects of risk factors for recurrent atrial tachyarrhythmia (ATA), a multivariable logistic regression model was used with the following 11 factors as independent variables: age, sex, body mass index, F-wave grade, preoperative LA volume index, preoperative duration of persistent AF, intraoperative net fluid balance, net fluid balance during CBP, intraoperative amount of transfusion, amount of transfusion during CBP, and intraoperative beta-blocker infusion. In addition, we assessed for the non-linear effect of intraoperative net fluid balance and net fluid balance during CPB on the recurrence of ATA, restricted cubic splines with 3 knots were used for each variable. Missing data were imputed with the multiple imputation method using the aregImpute function in the rms package in R. Internal validation using the bootstrap method with 200 replications was performed to assess overfitting of the regression model. All statistical analyses were performed with 2-sided 5% significance level using R 3.6.0 (The R Foundation for Statistical Computing, Vienna, Austria).
Management information
Registered date
| 2019 | Year | 08 | Month | 10 | Day |
Last modified on
| 2021 | Year | 06 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042950
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