UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief title)	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	Seimi Kobayashi
Organization	Kobe university hospital
Division name	Cardiovascular medicine
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	Seimi Kobayashi
Organization	Kobe university hospital
Division name	Cardiovascular medicine
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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2018 Year 03 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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