Table 2.
Results of primary, secondary, exploratory and safety endpoints
| Endpoints | Difference vs baseline (95% CI) | Comparison of changes, BCAA vs control | |
|---|---|---|---|
| BCAA (N = 7) | Control (N = 9) | ||
| Hospital stay (days) | 29.1 ± 10.2 | 28.8 ± 12.2 | 0.95 |
| Study duration (days) | 15.6 ± 7.9 | 10.1 ± 5.4 | 0.15 |
| Primary efficacy endpoint | |||
| Change of serum albumin, g/dL | 0.44 (0.13 to 0.76)* | 0.18 (− 0.05 to 0.40) | P = 0.117 |
| Change of cardiothoracic ratio, % | − 2.3 (− 3.8 to − 0.8)¶,* | − 1.0 (− 2.3 to 0.3) | P = 0.161 |
| Secondary efficacy endpoint | |||
| Change of BNP, pg/mL | − 269 (− 594 to 56) | − 114 (− 297 to 69) | P = 0.31 |
| Change of BCAA, μmol/L | 73 (− 8 to 154) | 21 (− 24 to 67) | P = 0.182 |
| Change of Fisher ratio | 0.64 (− 0.06 to 1.33) | 0.08 (− 0.33 to 0.49) | P = 0.102 |
| Change of food intake proportion, % | 8 (− 11 to 26) | − 4 (− 18 to 11) | P = 0.27 |
| Hospital stay length, mean ± SD days | 29 ± 10 | 29 ± 12 | P = 0.95 |
| Exploratory endpoint | |||
| Change of body weight, kg | − 3.0 (− 6.4 to 0.5) | − 1.6 (− 3.2 to 0.1) | P = 0.33 |
| Change of systolic BP, mmHg | − 5 (− 21 to 12) | − 14 (− 27 to −1)* | P = 0.30 |
| Change of diastolic BP, mmHg | 0 (− 14 to 14) | − 8 (− 19 to 3) | P = 0.32 |
| Change of cholinesterase, IU/L | 38 (9 to 67)* | 7 (− 16 to 29) | P = 0.059 |
| Safety endpoint | |||
| Change of serum creatinine, mg/dL | 0.03 (− 0.07 to 0.12) | 0.04 (− 0.09 to 0.17) | P = 0.89 |
| Change of urea nitrogen, mg/dL | 9.1 (1.6 to 16.6)* | 2.8 (− 3.3 to 8.9) | P = 0.146 |
| Change of ammonia, μg/dL | − 3.4 (− 18.3 to 11.4) | − 1.9 (− 15.0 to 11.3) | P = 0.86 |
Parameters with significant changes are in bold
BCAA branched-chain amino acid, BNP B-type natriuretic peptide, BP blood pressure, CI confidence interval, SD standard deviation
*P < 0.05 vs baseline
¶N = 5; two patients in BCAA group were excluded from the cardiothoracic ratio analysis because chest X-rays with the same position (anterior-posterior or posterior-anterior) before and after BCAA supplementation were not available