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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000030490
Receipt No. R000034773
Scientific Title Efficacy of preoperative amino acids administration on postoperative physical function and complications for elderly patients undergoing open heart surgery: a single center randomized controlled trial
Date of disclosure of the study information 2018/03/01
Last modified on 2018/08/30

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Basic information
Public title Efficacy of preoperative amino acids administration on postoperative physical function and complications for elderly patients undergoing open heart surgery: a single center randomized controlled trial
Acronym Efficay of preoperative amino acids administaration on post cardiac surgery course
Scientific Title Efficacy of preoperative amino acids administration on postoperative physical function and complications for elderly patients undergoing open heart surgery: a single center randomized controlled trial
Scientific Title:Acronym Efficay of preoperative amino acids administaration on post cardiac surgery course
Region
Japan

Condition
Condition patients undergoing open-heart surgery
Classification by specialty
Cardiology Cardiovascular surgery Rehabilitation medicine
Nursing
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the effect of short-term amino acid administartion on post operative physical function and complications.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Difference for change in 6-minute walk test distance between pre- and post-operation.
Key secondary outcomes 1. Difference for incidence of postoperative complications.
2. Difference for changes in nutritional status.
3. Difference for change in physical function (grip strength, knee extensor muscle strength, body composition, short physical performance battery score, and physical activity estimates).
4. Difference in psychological, and health status.
5. Difference for changes in inflammatory status.
6. Difference for hospital mortality
7. Difference for hospital length of stay
8. Difference for ICU length of stay

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Oral administraion of amino acid (abund) for 14-28 days
Interventions/Control_2 No intervention
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
65 years-old <=
Age-upper limit
100 years-old >
Gender Male and Female
Key inclusion criteria Patients undergoing open-heart surgery in Kobe University Hospital.
1. Patietns with age greater than or equal to 65 years
2. Patients who agreed to study participants
Key exclusion criteria 1. patients with BNP more than 500pg/ml.
2. patients with eGFR<30ml/min/1.73m2.
3. patients with T-Bil>2.0mg/dL
4. patients with congenital branched chain amino acid metabolism disorders
5. Patients whose consent was not obtained
6.Participation in any clinical research study evaluating another investigational drug or therapy within 4 months prior to randomization
7. presence of other conditions, which
make the patient unsuitable for the study according to the judgment of the principal investigatoror or coinvestigator.
8. Patients who can not perform 6 minutes walking test
9. Patients who take amino acids supplements prior to randomization
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Seimi Kobayashi
Organization Kobe university hospital
Division name Cardiovascular medicine
Zip code
Address 7-5-2 Kusunoki-cho, Chuo-ku, Kobe 6500017, Japan
TEL 078-382-5846
Email seimik@med.kobe-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Seimi Kobayashi
Organization Kobe university hospital
Division name Cardiovascular medicine
Zip code
Address 7-5-2 Kusunoki-cho, Chuo-ku, Kobe 6500017, Japan
TEL 078-382-5846
Homepage URL
Email seimik@med.kobe-u.ac.jp

Sponsor
Institute Kobe university
Institute
Department

Funding Source
Organization Kobe university
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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 神戸大学医学部附属病院

Other administrative information
Date of disclosure of the study information
2018 Year 03 Month 01 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
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 Enrolling by invitation
Date of protocol fixation
2018 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2018 Year 07 Month 19 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 12 Month 20 Day
Last modified on
2018 Year 08 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034773

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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