Variablea | Study Timeline | L-carnitine (n = 30), mean ± SD) | Placebo (n = 30), mean ± SD) | p-value2 | p-value3 | p-value4 | |
---|---|---|---|---|---|---|---|
Hepatic status | ALT (U/L) | Baseline | 36.43 ± 20.13 | 42.20 ± 38.49 | 0.953 | 0.430 | 0.303 |
Endpoint | 40.44 ± 32.33 | 38.90 ± 34.79 |  | ||||
Mean difference ± SD | 4.01 ± 26.44 | -3.30 ± 8.28 |  | ||||
p-value | 0.789 | 0.284 | Â | Â | Â | ||
AST (U/L) | Baseline | 42.20 ± 24.59 | 47.23 ± 38.63 | 0.879 | 0.587 | 0.672 | |
Endpoint | 40.20 ± 21.98 | 44.50 ± 27.43 |  | ||||
Mean difference ± SD | -2.00 ± 27.37 | -2.74 ± 21.86 |  | ||||
p-value | 0.571 | 0.919 | Â | Â | Â | ||
ALP (U/L) | Baseline | 255.77 ± 168.94 | 265.70 ± 174.59 | 0.617 | 0.532 | 0.327 | |
Endpoint | 263.09 ± 168.86 | 288.82 ± 193.23 |  | ||||
Mean difference ± SD | 7.32 ± 48.79 | 23.12 ± 49.96 |  | ||||
p-value | 0.645 | 0.114 | Â | Â | Â | ||
Biochemistry tests | BUN (mg/dl) | Baseline | 22.37 ± 21.38 | 24.20 ± 18.90 | 0.337 | 0.971 | 0.965 |
Endpoint | 19.28 ± 12.00 | 19.57 ± 10.23 |  | ||||
Mean difference ± SD | -3.09 ± 15.18 | -4.63 ± 12.59 |  | ||||
p-value | 0.903 | 0.284 | Â | Â | Â | ||
Cr (mg/dl) | Baseline | 1.03 ± 0.49 | 1.43 ± 0.82 | 0.038 | 0.218 | 0.470 | |
Endpoint | 1.08 ± 0.48 | 1.22 ± 0.60 |  | ||||
Mean difference ± SD | 0.05 ± 0.42 | -0.21 ± 0.56 |  | ||||
p-value | 0.292 | 0.062 | Â | Â | Â | ||
Alb (g/dl) | Baseline | 2.55 ± 0.48 | 2.69 ± 0.65 | 0.368 | 0.036 | 0.027 | |
Endpoint | 2.66 ± 0.50 | 2.63 ± 0.56 |  | ||||
Mean difference ± SD | 0.11 ± 0.26 | -0.06 ± 0.26 |  | ||||
p-value | 0.025 | 0.343 | Â | Â | Â | ||
BS (mg/dl) | Baseline | 140.77 ± 46.64 | 120.47 ± 46.77 | 0.064 | 0.615 | 0.526 | |
Endpoint | 147.04 ± 73.27 | 119.59 ± 38.99 |  | ||||
Mean difference ± SD | 6.27 ± 62.95 | -0.88 ± 22.81 |  | ||||
p-value | 0.976 | 0.743 | Â | Â | Â | ||
Total Bilirubin (mg/dl) | Baseline | 1.06 ± 1.37 | 1.30 ± 1.21 | 0.062 | 0.462 | 0.532 | |
Endpoint | 0.78 ± 0.25 | 1.02 ± 0.59 |  | ||||
Mean difference ± SD | -0.29 ± 1.34 | -0.28 ± 1.09 |  | ||||
p-value | 0.602 | 0.106 | Â | Â | Â | ||
Direct Bilirubin (mg/dl) | Baseline | 0.32 ± 0.17 | 0.57 ± 0.74 | 0.018 | 0.626 | 0.576 | |
Endpoint | 0.28 ± 0.12 | 0.41 ± 0.40 |  | ||||
Mean difference ± SD | -0.02 ± 0.07 | -0.16 ± 0.39 |  | ||||
p-value | 0.719 | 0.072 | Â | Â | Â | ||
Na (mEq/L) | Baseline | 139.47 ± 4.30 | 138.20 ± 5.52 | 0.326 | 0.173 | 0.300 | |
Endpoint | 139.60 ± 4.97 | 137.75 ± 3.54 |  | ||||
Mean difference ± SD | 0.13 ± 5.29 | -0.45 ± 5.38 |  | ||||
p-value | 0.892 | 0.649 | Â | Â | Â | ||
K (mEq/L) | Baseline | 3.91 ± 0.42 | 4.05 ± 0.47 | 0.224 | 0.581 | 0.292 | |
Endpoint | 4.01 ± 0.38) | 4.11 ± 0.61) |  | ||||
Mean difference ± SD | 0.10 ± 0.51 | 0.05 ± 0.73 |  | ||||
p-value | 0.290 | 0.688 | Â | Â | Â | ||
P (mg/dl) | Baseline | 3.04 ± 0.75 | 3.12 ± 1.01 | 0.717 | 0.249 | 0.212 | |
Endpoint | 2.96 ± 0.67 | 2.86 ± 0.48 |  | ||||
Mean difference ± SD | -0.83 ± 0.58 | -0.26 ± 0.75 |  | ||||
p-value | 0.441 | 0.062 | Â | Â | Â | ||
Mg (mg/dl) | Baseline | 1.91 ± 0.35 | 1.93 ± 0.41 | 0.839 | 0.914 | 0.911 | |
Endpoint | 1.89 ± 0.32 | 1.91 ± 0.43 |  | ||||
Mean difference ± SD | -0.02 ± 0.30 | -0.02 ± 0.50 |  | ||||
p-value | 0.722 | 0.812 | Â | Â | Â | ||
Ca (mg/dl) | Baseline | 7.27 ± 0.73 | 8.07 ± 0.81 | 0.091 | 0.360 | 0.686 | |
Endpoint | 7.93 ± 0.74 | 8.06 ± 0.62 |  | ||||
Mean difference ± SD | 0.20 ± 0.53 | -0.02 ± 0.45 |  | ||||
p-value | 0.049 | 0.856 | Â | Â | Â | ||
CBC diff test | RBC (1012/L) | Baseline | 3.49 ± 0.55 | 3.70 ± 0.71 | 0.252 | 0.967 | 0.788 |
Endpoint | 3.56 ± 0.65 | 3.65 ± 0.54 |  | ||||
Mean difference ± SD | 0.07 ± 0.56 | -0.06 ± 0.56 |  | ||||
p-value | 0.527 | 0.779 | Â | Â | Â | ||
WBC (109/L) | Baseline | 9.96 ± 3.75 | 8.23 ± 3.06 | 0.059 | 0.290 | 0.154 | |
Endpoint | 8.95 ± 3.13 | 8.82 ± 3.94 |  | ||||
Mean difference ± SD | -1.01 ± 2.54 | 0.59 ± 3.91 |  | ||||
p-value | 0.059 | 0.366 | Â | Â | Â | ||
Lymphocyte (%) | Baseline | 13.65 ± 8.11) | 15.32 ± 9.25 | 0.444 | 0.113 | 0.193 | |
Endpoint | 13.46 ± 6.54 | 17.74 ± 10.81 |  | ||||
Mean difference ± SD | -0.20 ± 7.22 | 2.42 ± 12.00 |  | ||||
p-value | 0.744 | 0.178 | Â | Â | Â | ||
Neutrophil (%) | Baseline | 73.13 ± 16.53 | 74.56 ± 11.51 | 0.871 | 0.167 | 0.116 | |
Endpoint | 74.69 ± 10.97 | 70.80 ± 15.23 |  | ||||
Mean difference ± SD | 1.56 ± 10.67 | -3.75 ± 16.40 |  | ||||
p-value | 0.727 | 0.207 | Â | Â | Â | ||
Hb (g/dl) | Baseline | 9.74 ± 1.53 | 10.31 ± 1.62 | 0.220 | 0.675 | 0.741 | |
Endpoint | 9.76 ± 1.48 | 10.20 ± 2.00 |  | ||||
Mean difference ± SD | 0.01 ± 1.58 | -0.12 ± 1.36 |  | ||||
p-value | 0.996 | 0.645 | Â | Â | Â | ||
Hct (%) | Baseline | 28.86 ± 3.86 | 31.38 ± 5.86 | 0.054 | 0.405 | 0.409 | |
Endpoint | 29.05 ± 3.85 | 31.05 ± 4.55 |  | ||||
Mean difference ± SD | 0.19 ± 4.30 | -0.34 ± 4.34 |  | ||||
p-value | 0.810 | 0.675 | Â | Â | Â | ||
MCV (fL) | Baseline | 83.12 ± 6.34 | 83.81 ± 10.43 | 0.295 | 0.316 | 0.435 | |
Endpoint | 83.20 ± 6.41 | 85.41 ± 3.58 |  | ||||
Mean difference ± SD | 0.08 ± 3.56 | 1.60 ± 10.06 |  | ||||
p-value | 0.891 | 0.852 | Â | Â | Â | ||
MCH (pg) | Baseline | 27.69 ± 2.55 | 28.02 ± 2.30 | 0.589 | 0.174 | 0.421 | |
Endpoint | 27.75 ± 2.45 | 28.44 ± 2.71 |  | ||||
Mean difference ± SD | 0.06 ± 1.15 | 0.42 ± 1.09 |  | ||||
p-value |  < 0.001 |  < 0.001 |  |  |  | ||
MCHC (g/dl) | Baseline | 33.11 ± 1.38 | 32.47 ± 1.68 | 0.114 | 0.689 | 0.616 | |
Endpoint | 33.91 ± 2.24 | 33.91 ± 3.03 |  | ||||
Mean difference ± SD | 0.80 ± 2.41 | 1.43 ± 2.99 |  | ||||
p-value | 0.081 | 0.014 | Â | Â | Â | ||
Plt (/ml) | Baseline | 241.47 ± 116.47 | 260.13 ± 127.15 | 0.556 | 0.004 | 0.042 | |
Endpoint | 276.26 ± 110.86 | 220.30 ± 94.34 |  | ||||
Mean difference ± SD | 34.80 ± 109.82 | -39.83 ± 98.67 |  | ||||
p-value | 0.093 | 0.035 | Â | Â | Â | ||
ABG test | pH | Baseline | 7.42 ± 0.08 | 7.39 ± 0.09 | 0.207 | 0.999 | 1.000 |
Endpoint | 7.47 ± 0.12 | 7.44 ± 0.10 |  | ||||
Mean difference ± SD | 0.05 ± 0.13 | 0.05 ± 0.11 |  | ||||
p-value |  < 0.001 |  < 0.001 |  |  |  | ||
PCO2 (mmHg) | Baseline | 41.70 ± 8.48 | 48.34 ± 15.76 | 0.110 | 0.633 | 0.809 | |
Endpoint | 39.42 ± 9.66 | 43.18 ± 13.17 |  | ||||
Mean difference ± SD | -2.28 ± 10.27 | -5.16 ± 13.37 |  | ||||
p-value | 0.194 | 0.060 | Â | Â | Â | ||
PO2 (mmHg) | Baseline | 110.95 ± 36.29 | 94.27 ± 40.09 | 0.096 | 0.779 | 0.558 | |
Endpoint | 91.07 ± 29.08 | 84.87 ± 25.43 |  | ||||
Mean difference ± SD | -19.88 ± 36.18 | -9.40 ± 40.08 |  | ||||
p-value | 0.005 | 0.209 | Â | Â | Â | ||
BE (mmol/L) | Baseline | 2.48 ± 6.30 | 3.63 ± 4.05 | 0.405 | 0.590 | 0.673 | |
Endpoint | 2.27 ± 6.11 | 2.15 ± 5.10 |  | ||||
Mean difference ± SD | -0.21 ± 6.32 | -1.48 ± 4.76 |  | ||||
p-value | 0.856 | 0.099 | Â | Â | Â | ||
HCO3 (mmol/L) | Baseline | 26.39 ± 6.03 | 28.38 ± 4.84 | 0.165 | 0.610 | 0.731 | |
Endpoint | 26.21 ± 6.81 | 27.77 ± 6.10 |  | ||||
Mean difference ± SD | -0.18 ± 7.22 | -0.61 ± 6.93 |  | ||||
p-value | 0.893 | 0.633 | Â | Â | Â | ||
Coagulation status | PT (s) | Baseline | 13.71 ± 4.05 | 13.53 ± 3.66 | 0.976 | 0.443 | 0.767 |
Endpoint | 13.39 ± 2.87 | 13.49 ± 2.79 |  | ||||
Mean difference ± SD | -0.32 ± 2.67 | -0.04 ± 3.84 |  | ||||
p-value | 0.992 | 0.333 | Â | Â | Â | ||
PTT (s) | Baseline | 30.21 ± 5.08 | 33.29 ± 11.29 | 0.175 | 1.000 | 0.534 | |
Endpoint | 32.98 ± 9.38 | 33.56 ± 10.53 |  | ||||
Mean difference ± SD | 2.78 ± 9.67 | 0.26 ± 10.53 |  | ||||
p-value |  < 0.001 |  < 0.001 |  |  |  | ||
INR | Baseline | 1.29 ± 0.21 | 1.35 ± 0.37 | 0.709 | 0.180 | 0.346 | |
Endpoint | 1.28 ± 0.18 | 1.35 ± 0.28 |  | ||||
Mean difference ± SD | -0.01 ± 0.13 | 0.00 ± 0.38 |  | ||||
p-value | 0.841 | 0.145 | Â | Â | Â | ||
Urinary status | SG | Baseline | 1018.83 ± 5.72 | 1020.10 ± 6.27 | 0.417 | 0.715 | 0.659 |
Endpoint | 1018.96 ± 5.20 | 1019.80 ± 5.30 |  | ||||
Mean difference ± SD | 0.127 ± 5.77 | -0.31 ± 7.28 |  | ||||
p-value | 0.905 | 0.820 | Â | Â | Â | ||
Urinary pH | Baseline | 6.43 ± 1.07 | 6.23 ± 1.19 | 0.498 | 0.804 | 0.767 | |
Endpoint | 6.43 ± 1.00 | 6.33 ± 0.98 |  | ||||
Mean difference ± SD | 0.000 ± 1.27 | 0.095 ± 1.34 |  | ||||
p-value | 0.998 | 0.701 | Â | Â | Â | ||
Other monitoring variables | Temperature (°C) | Baseline | 37.77 ± 0.97 | 37.55 ± 0.72 | 0.321 | 0.151 | 0.269 |
Endpoint | 37.40 ± 0.48 | 37.45 ± 0.48 |  | ||||
Mean difference ± SD | -0.37 ± 0.76 | -0.10 ± 0.46 |  | ||||
p-value | 0.012 | 0.231 | Â | Â | Â | ||
SBP (mmHg) | Baseline | 126.63 ± 21.87 | 113.17 ± 17.94 | 0.012 | 0.030 | 0.007 | |
Endpoint | 117.05 ± 20.72 | 98.17 ± 24.21 |  | ||||
Mean difference ± SD | -9.58 ± 21.98 | -14.99 ± 24.16 |  | ||||
p-value | 0.024 | 0.002 | Â | Â | Â | ||
DBP (mmHg) | Baseline | 85.30 ± 21.71 | 92.37 ± 27.76 | 0.277 | 0.393 | 0.027 | |
Endpoint | 76.29 ± 7.93 | 75.53 ± 8.44 |  | ||||
Mean difference ± SD | -9.02 ± 18.33 | -16.84 ± 26.65 |  | ||||
p-value | 0.012 | 0.002 | Â | Â | Â | ||
PRL (ng/ml) | Baseline | 59.37 ± 32.87 | 48.05 ± 20.62 | 0.006 | 0.236 | 0.197 | |
Endpoint | 55.61 ± 27.06 | 44.95 ± 17.89 |  | ||||
Mean difference ± SD | -3.76 ± 31.76 | -3.10 ± 21.77 |  | ||||
p-value | 0.521 | 0.442 | Â | Â | Â |