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Table 4 Monitoring laboratory variables in the intervention group (L-carnitine) and control group (placebo) at baseline and end of the trial (day 7)

From: The effects of L-carnitine supplementation on inflammation, oxidative stress, and clinical outcomes in critically Ill patients with sepsis: a randomized, double-blind, controlled trial

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

   
  1. 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
  2. 1Obtained from Paired sample t-test
  3. 2Obtained from Independent Sample t-test
  4. 3Obtained from analysis of covariance (ANCOVA) in the adjusted models (adjusted for baseline value)
  5. 4Obtained from analysis of covariance (ANCOVA) in the adjusted models (adjusted for baseline value and ESR)
  6. aValues are Mean ± Standard deviation