UMIN-CTR Clinical Trial

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
Email	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
Email	k.minami@ncvc.go.jp

Sponsor
Institute	National cerebral and cardiovascular center
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042950