UMIN-ICDS Clinical Trial

Public title

Clinical impact of Femoral artery cannulation laterality on surgical results in Minimally Invasive Cardiac Surgery.

Acronym

Clinical impact of Femoral artery cannulation laterality on surgical results in Minimally Invasive Cardiac Surgery.

Scientific Title

Clinical impact of FA cannulation laterality on surgical results in MICS. -A single center Open label Minimization Randomized controlled trial-

Scientific Title:Acronym

Clinical impact of FA cannulation laterality on surgical results in MICS.

Region

Japan

Condition

Valvular heart disease
Congenital heart disease
Intracardiac myxoma

Classification by specialty

Cardiovascular surgery

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Compare and study the clinical impact of FA cannulation laterality in MICS. The effects of the positions of cannulas.

Basic objectives2

Bio-equivalence

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

rSO2(During extracorporeal circulation)
CK(right after,6 hours after,1 day after operation)
Lac(right after,6 hours after,1 day after operation)

Key secondary outcomes

Following items during, after, and each point of time of operation (If the item can show the change in amount compared to the preoperative period, it will be also included)

[Preoperative factors]
･HT
･DM
･AST
･ALT
･LDH
･Cre
･Lac
･ABI
･baPWV
･CKD stage
･Calf circumference (when entering the operating room)
･Operative method
･EF
･EuroSCORE 2
･Rate of occlusion

[Intraoperative factors]
･Size of cannula
･CPB time
･Aorta clamp time
･Amount of urine during on CPB
･rSO2
･Fluid balance
･Amount of hypertensive drug and hypotensive drug use
･Diameter of bilateral FA and FV

[Postoperative factors]
･Amount of urine
･max Cre
･max CK
･max Lac
･AST
･ALT
･LDH
･Calf circumference (when exiting the operating room, POD1)
･Number of days patient could walk 150 meters, number of days after operation before patient starts to walk again

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Insert the arterial cannula to the same side (right femoral artery) regarding the location of venous cannula (right femoral vein)

Interventions/Control_2

Insert the arterial cannula to the opposite side (left femoral artery) regarding the location of venous cannula (right femoral vein)

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1)Patient who will undergo extracorporeal circulation via femoral artery in MICS for the treatment of valvular heart disease, congenital heart disease, and others
2)Patient over 20 years old at the time of having a consent (regardless of gender)
3)Suitable / Targeted patient for this research who consented by documents with the free will of self or the representative after receiving enough explanation

Key exclusion criteria

1)Dialysis patient
2)Patient with ASO
3)Patient with re-operation
4)Patient who was judged as a not eligible target for this by doctor

Target sample size

60

Name of lead principal investigator

1st name	Yoshitsugu
Middle name
Last name	Nakamura

Organization

CHIBA-NISHI GENERAL HOSPITAL

Division name

Cardiovascular Surgery

Zip code

270-2251

Address

107-1,Kanegasaku,Matsudo-shi,Chiba, 270-2251,Japan

TEL

047-384-8111

Email

ystgnkmr@gmail.com

Name of contact person

1st name	Masahiko
Middle name
Last name	Sudo

Organization

CHIBA-NISHI GENERAL HOSPITAL

Division name

Clinical Engineering Department

Zip code

270-2251

Address

107-1,Kanegasaku,Matsudo-shi,Chiba, 270-2251,Japan

TEL

047-384-8111

Homepage URL

Email

me@chibanishi-hp.or.jp

Institute

CHIBA-NISHI GENERAL HOSPITAL

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

The Tokushukai Group Ethics Committee

Address

Tokyodo Chiyoda Bldg. 15F, 1-3-1, Kudan-minami, Chiyoda-ku, Tokyo 102-0074, Japan

Tel

03-3263-4801

Email

mirai-ec1@mirai-iryo.com

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2023

Year

11

Month

27

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Preinitiation

Date of protocol fixation

2023

Year

09

Month

20

Day

Date of IRB

2023

Year

09

Month

20

Day

Anticipated trial start date

2023

Year

10

Month

30

Day

Last follow-up date

2024

Year

12

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2023

Year

10

Month

13

Day

Last modified on

2023

Year

11

Month

19

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058879