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
Not Applicable
Recruiting
- Conditions
- patients undergoing open-heart surgery
- Registration Number
- JPRN-UMIN000030490
- Lead Sponsor
- Kobe university
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 200
Inclusion Criteria
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Difference for change in 6-minute walk test distance between pre- and post-operation.
- Secondary Outcome Measures
Name Time Method 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