Effect of empagliflozin on fractional excretion of sodium in patients with cirrhosis and refractory ascites

Table 1 Study schedule

Study period	Screening period (14-day)	Patient enrollment (day 0)	Day 1	Day 3	Day 7	Day 10	Day 141	Day 282 (end of follow-up)
Informed consent	√
Demographic data	√
Medical history	√
Inclusion/exclusion criteria	√
Vital signs	√	√	√	√	√	√	√	√
Blood routine + reticulocytes		√			√		√
HbA1c3		√
Urine routine		√	√	√	√	√	√
Urine electrolytes + urine creatinine + urine glucose4		√	√	√	√	√	√	√
Liver and kidney function + blood glucose + cardiac enzymes + blood lipids		√			√		√	√
AFP and PIVKA-II	√
Abdominal ultrasound + ascites	√						√	√
Enhanced abdominal CT5	√
ECG	√
Echocardiography	√
24-hour urine measurement		√	√	√	√	√	√
Blood sample collection		√					√
RAAS assays6
Urine sample collection		√					√
Concomitant medication	√	√	√	√	√	√	√	√
Adverse events		√	√	√	√	√	√
Body weight		√	√	√	√	√	√	√

¹If the patient is discharged within 14 days, all assessments scheduled for day 14 should be performed either the day before discharge or on the day of discharge.

²The liver and kidney function, urine electrolytes, urine creatinine, urine glucose tests, and ultrasound examination performed at the follow-up on day 28 or 14 days after discharge are free of charge. These tests will be conducted at the outpatient and can be scheduled within a window of 14 ± 7 days after discharge.

³If blood glucose levels are normal and the patient has no history of diabetes; the glycated hemoglobin test may be omitted.

⁴Urine glucose measurement in urine electrolytes should be quantitative.

⁵If both alpha-fetoprotein and protein induced by vitamin K absence or antagonist-II are normal, and abdominal ultrasound shows no signs of primary liver tumors, abdominal contrast-enhanced computed tomography may be omitted.

⁶Renin-angiotensin-aldosterone system assays include measurements of total renin level, plasma renin activity, angiotensin II level, and aldosterone level.

HbA1c: Glycated hemoglobin; AFP: Alpha-fetoprotein; PIVKA-II: Protein induced by vitamin K absence or antagonist-II; CT: Computed tomography; ECG: Electrocardiogram; RAAS: Renin-angiotensin-aldosterone system.