UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025737 |
|---|---|
| Receipt number | 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 22:11:40 |
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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
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
shingu@huhp.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Hospital; Department of Cardiovascular and Thoracic Surgery
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029371
