UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030490
Receipt number 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 16:08:15

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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 or person

Institute

Kobe university

Institute

Department

Personal name



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

Value
https://center6.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