Open-label randomized controlled study of salt-restricted vs salt-unrestricted diet in patients with cirrhosis with hyponatremia

Table 1 Baseline characteristics of study participants, mean ± SD/n (%)

Variable (unit)	SRD (n = 51)	SUD (n = 54)	P value
Age, (years)	49.33 ± 14.71	46.83 ± 11.94	0.340
Sex, male:female	36:15 (70.6:29.4)	50:4 (92.6:7.4)	0.003
Etiology of cirrhosis			0.150
Ethanol	12 (23.5)	26 (48.1)
Hepatitis B virus	8 (15.7)	5 (9.3)
Hepatitis C virus	2 (3.9)	0 (0)
MASLD	9 (17.6)	9 (16.7)
Mixed/others	20 (39.2)	14 (25.9)
ACLF at presentation	5 (9.8)	4 (7.4)	0.608
Diabetes mellitus	13 (25.5)	15 (27.8)	0.791
Mean arterial pressure (mmHg)	82.77 ± 12.84	83.57 ± 11.72	0.736
Body mass index (kg/m2)	21.04 ± 4.86	20.44 ± 3.62	0.476
Abdominal circumference (cm)	92.30 ± 10.73	90.48 ± 10.67	0.387
Severity of hyponatremia			0.973
Moderate (125-129 mEq/L)	31 (60.8)	33 (61.1)
Severe (< 125 mEq/L)	20 (39.2)	21 (38.9)
Grade of ascites			0.214
Controlled	7 (13.7)	9 (16.7)
Grade I	4 (7.8)	6 (11.1)
Grade II	17 (33.3)	13 (24.1)
Grade III	26 (51.0)	23 (42.6)
Prior LVP	12 (23.5)	11 (20.4)	0.696
Prior AKI	10 (19.6)	11 (20.4)	0.922
Thyroid-stimulating hormone (μIU/mL)	5.82 ± 7.22	4.20 ± 2.68	0.127
Cortisol (μg/dL)	14.81 ± 6.17	14.35 ± 4.28	0.655
TLC (cells/mm3)	7115.69 ± 3652.82	8379.07 ± 5607.03	0.177
Bilirubin (mg/dL)	5.74 ± 7.23	4.66 ± 5.39	0.388
Aspartate transaminase (U/L)	109.24 ± 141.95	113.49 ± 87.19	0.853
Alanine transaminase (U/L)	60.05 ± 94.75	43.84 ± 20.68	0.223
Potassium (mEq/L)	4.18 ± 0.68	4.35 ± 0.63	0.198
Hemoglobin (g/dL)	8.65 ± 2.28	8.76 ± 2.31	0.803
Urea (mg/dL)	35.10 ± 14.09	31.83 ± 15.69	0.265
Creatinine (mg/dL)	0.83 ± 0.32	0.81 ± 0.26	0.779
Sodium (mEq/L)	125.60 ± 3.48	124.99 ± 4.30	0.429
Chloride (mEq/L)	97.13 ± 5.69	95.96 ± 6.80	0.342
eGFR by MDRD6 (mL/minute/1.73 m2)	97.68 ± 66.00	104.85 ± 57.54	0.558
Albumin (g/dL)	2.59 ± 0.46	2.74 ± 0.57	0.130
Mid arm circumference (cm)	21.09 ± 4.18	22.11 ± 3.12	0.161
Handgrip strength (kg) female	10.7 ± 4.67	12.2 ± 4.60	0.565
Handgrip strength (kg) male	18.8 ± 6.51	20.5 ± 6.51	0.151
Child-Turcotte-Pugh score	9.65 ± 2.17	9.13 ± 2.24	0.233
MELD-Na score	23.28 ± 7.80	22.41 ± 8.55	0.589
Baseline calorie intake (kcal/day)	1356.45 ± 512.33	1450.48 ± 517.93	0.352

ACLF: Acute-on-Chronic Liver Failure; AKI: Acute kidney injury; eGFR: Estimated glomerular filtration rate; LVP: Large-volume paracentesis; MASLD: Metabolic Dysfunction-Associated Steatotic Liver Disease; MDRD6: Modification of diet in renal disease 6-variable formula; MELD-Na: Model for end-stage liver disease incorporating serum sodium; SRD: Salt-restricted diet; SUD: Salt-unrestricted diet; TLC: Total leukocyte count.

Table 2 Comparison of baseline variables between acute kidney injury and no-acute kidney injury groups, mean ± SD/n (%)

Variable	No AKI (n = 60)	AKI (n = 45)	P value
Age (years)	47.17 ± 14.14	49.22 ± 12.26	0.43
Sex			0.56
Male	51 (85.0)	35 (77.8)
Female	9 (15.0)	10 (22.2)
Dietary group			0.002
Salt restricted	21 (35.0)	30 (66.7)
Salt unrestricted	39 (65.0)	15 (33.3)
Prior history of AKI	5 (8.3)	16 (35.6)	< 0.001
Prior diuretic use	37 (61.7)	28 (62.2)	0.954
Prior LVP	12 (20.0)	11 (24.4)	0.58
Urine protein present	13 (21.7)	11 (24.4)	0.10
TLC (cells/mm3)	7010 ± 3986	8772 ± 5556	0.06
MAP (mmHg)	85.63 ± 12.31	79.91 ± 11.42	0.017
MAC (cm)	21.38 ± 4.04	21.92 ± 3.16	0.45
BMI (kg/m2)	20.45 ± 4.50	21.10 ± 3.93	0.44
Sodium (mEq/L)	125.19 ± 4.00	125.41 ± 3.83	0.78
Chloride (mEq/L)	95.86 ± 5.61	97.41 ± 7.05	0.21
Albumin (g/dL)	2.73 ± 0.48	2.57 ± 0.56	0.13
Handgrip strength (kg)	18.71 ± 6.74	18.13 ± 7.19	0.67
CTP score	9.15 ± 2.19	9.69 ± 2.22	0.21
MELD-Na score	22.43 ± 8.18	23.36 ± 8.19	0.56
Baseline calorie intake (kcal/day)	1458 ± 546.5	1333 ± 465.72	0.21

AKI: Acute kidney injury; BMI: Body mass index; CTP: Child-Turcotte-Pugh score; LVP: Large-volume paracentesis; MAC: Mid arm circumference; MAP: Mean arterial pressure; MELD-Na: Model for end-stage liver disease incorporating serum sodium; TLC: Total leukocyte count.