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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025737
Receipt No. R000029371
Scientific Title Prevention of Postoperative Atrial Fibrillation after Heart Valve Surgery by L-Carnitine: Study Protocol for An Observational Intervention Study
Date of disclosure of the study information 2017/01/30
Last modified on 2019/03/23

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Basic information
Public title Prevention of Postoperative Atrial Fibrillation after Heart Valve Surgery by L-Carnitine: Study Protocol for An Observational Intervention Study
Acronym Prevention of Postoperative Atrial Fibrillation by L-Carnitine
Scientific Title Prevention of Postoperative Atrial Fibrillation after Heart Valve Surgery by L-Carnitine: Study Protocol for An Observational Intervention Study
Scientific Title:Acronym Prevention of Postoperative Atrial Fibrillation by L-Carnitine
Region
Japan

Condition
Condition Heart valve diseases
Classification by specialty
Surgery in general Vascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the safety and effectiveness of L-carnitine as a perioperative medication for postoperative atrial fibrillation
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The incidence of atrial fibrillation within seven days after surgery
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 The total intervention period will be nine days. L-carnitine (L-Cartin FF oral solution 10%, Otsuka Pharmaceutical Co., Ltd., Tokyo) (3 gm/day) will be administered daily to the patients in three oral doses (1 gm, 1 gm, and 1 gm) for two days just before surgery. The same doses will be given to the patients from postoperative days 1 to 7.
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
20 years-old <=
Age-upper limit
90 years-old >
Gender Male and Female
Key inclusion criteria 1. They are patients with a diagnosis of heart valve disease necessitating elective surgery under cardiac arrest through median sternotomy with or without coronary artery bypass grafting.
2. They are between 20 and 90 years of age.
3. They are competent and able to give informed consent.
Key exclusion criteria 1. They have a history of atrial fibrillation or flutter before surgery.
2. They have renal failure (serum creatinine > 2.0 mg/dl).
3. They are pregnant.
4. They are lactating.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Yoshiro
Middle name
Last name Matsui
Organization Hokkaido University Graduate School of Medicine
Division name Department of Cardiovascular and Thoracic Surgery
Zip code 060-8638
Address Kita 15, Nishi 7, Kitaku Sapporo, 060-8638, Japan
TEL 011-706-6042
Email ymatsui@med.hokudai.ac.jp

Public contact
Name of contact person
1st name Yasushige
Middle name
Last name Shingu
Organization Hokkaido University Graduate School of Medicine
Division name Department of Cardiovascular and Thoracic Surgery
Zip code 060-8638
Address Kita 15, Nishi 7, Kitaku Sapporo, 060-8638
TEL 011-706-6042
Homepage URL
Email shingu@huhp.hokudai.ac.jp

Sponsor
Institute Hokkaido University Hospital; Department of Cardiovascular and Thoracic Surgery
Institute
Department

Funding Source
Organization Hokkaido University Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Hokkaido University
Address Kita-14 Nishi-5, Kita-Ku, Sapporo, Japan
Tel 011-706-7636
Email crjimu@huhp.hokudai.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
2017 Year 01 Month 30 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 16
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 Completed
Date of protocol fixation
2017 Year 01 Month 19 Day
Date of IRB
2017 Year 05 Month 01 Day
Anticipated trial start date
2017 Year 07 Month 01 Day
Last follow-up date
2019 Year 03 Month 22 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 01 Month 19 Day
Last modified on
2019 Year 03 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029371

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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