Unique ID issued by UMIN | UMIN000030490 |
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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 |
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
Efficay of preoperative amino acids administaration on post cardiac surgery course
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
Efficay of preoperative amino acids administaration on post cardiac surgery course
Japan |
patients undergoing open-heart surgery
Cardiology | Cardiovascular surgery | Rehabilitation medicine |
Nursing |
Others
NO
To clarify the effect of short-term amino acid administartion on post operative physical function and complications.
Efficacy
Difference for change in 6-minute walk test distance between pre- and post-operation.
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
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
No treatment
2
Treatment
Food |
Oral administraion of amino acid (abund) for 14-28 days
No intervention
65 | years-old | <= |
100 | years-old | > |
Male and Female
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
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
200
1st name | |
Middle name | |
Last name | Seimi Kobayashi |
Kobe university hospital
Cardiovascular medicine
7-5-2 Kusunoki-cho, Chuo-ku, Kobe 6500017, Japan
078-382-5846
seimik@med.kobe-u.ac.jp
1st name | |
Middle name | |
Last name | Seimi Kobayashi |
Kobe university hospital
Cardiovascular medicine
7-5-2 Kusunoki-cho, Chuo-ku, Kobe 6500017, Japan
078-382-5846
seimik@med.kobe-u.ac.jp
Kobe university
Kobe university
Self funding
NO
神戸大学医学部附属病院
2018 | Year | 03 | Month | 01 | Day |
Unpublished
Enrolling by invitation
2018 | Year | 03 | Month | 01 | Day |
2018 | Year | 07 | Month | 19 | Day |
2017 | Year | 12 | Month | 20 | Day |
2018 | Year | 08 | Month | 30 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034773
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