Table 4.
Monitoring laboratory variables in the intervention group (L-carnitine) and control group (placebo) at baseline and end of the trial (day 7)
| 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 | |||||
| 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 | |||||
| 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 | |||||
| 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 | |||||
| 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 | |||||
| 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 | |||||
| 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 | |||||
| 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 | |||||
| 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 | |||||
| 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 | |||||
| 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 | |||||
| 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 | |||||
| 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 | |||||
| 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 | |||||
| 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 | |||||
| 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 | |||||
| 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 | |||||
| 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 | |||||
| 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 | |||||
| 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 | |||||
| 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 | |||||
| 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 | |||||
| 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 | |||||
| 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 | |||||
| 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 | |||||
| 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 | |||||
| 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 | |||||
| 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 | |||||
| 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 | |||||
| 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 | |||||
| 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 | |||||
| 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 | |||||
| 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 | |||||
| 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 | |||||
| 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 | |||||
ABG arterial blood gas, Alb Albumin, ALP Alkaline phosphatase, ALT alanine aminotransferase, AST aspartate aminotransferase, BE Base Excess, BS Blood sugar, BUN Blood urea nitrogen, Ca Calcium, CBC diff Complete blood count with differential, Cl Chloride, Cr Creatinine, DBP Diastolic blood pressure, Hb Hemoglobin, HCO3 bicarbonate, Hct Hematocrit, INR International normalized ration, K Potassium, MCH Mean corpuscular hemoglobin, MCHC Mean corpuscular hemoglobin concentration, MCV Mean corpuscular volume, Mg Magnesium; Na Sodium, P Phosphorus, PCO2 Partial pressure of carbon dioxide, Plt Platelets, PO2 partial pressure of oxygen, PT Prothrombin time, PTT Partial thromboplastin time, RBC Red blood cells, SBP Systolic blood pressure, SG Specific gravity, WBC White blood cells, SD standard deviation
1Obtained from Paired sample t-test
2Obtained from Independent Sample t-test
3Obtained from analysis of covariance (ANCOVA) in the adjusted models (adjusted for baseline value)
4Obtained from analysis of covariance (ANCOVA) in the adjusted models (adjusted for baseline value and ESR)
aValues are Mean ± Standard deviation