Effect of Midodrine in Non-azotemic Liver Cirrhosis Patients with Refractory or Recurrent Ascites

Objectives To study the effectiveness of midodrine in treatment of refractory, recurrent ascites in nonazotemic liver cirrhosis patients. Material and Methods This is a facility-based open-label parallel design randomized controlled trial conducted at the Regional Institute of Medical Sciences (RIMS), Imphal. All patients above the age of 18 with non-azotemic liver cirrhosis with refractory or recurrent ascites patients attending medicine out patient department (OPD), liver clinic, and those admitted to the medicine ward, RIMS, Imphal, were enrolled. After getting informed consent, the patients were allocated to standard medical therapy (SMT) with the midodrine group (group A) and the SMT group (group B). Since there were two treatment options involved, a block size of four was used. Possible treatment allocation within each block was (1) AABB, (2) BBAA, (3) ABAB, (4) BABA, (5) ABBA and (6) BAAB. Both the study participants and the investigator were double-blinded. Mean arterial blood pressure, weight, frequency and volume of indicated large volume paracentesis (LVP), volume of urine in 24-hour, Estimated glomerular filtration rate (eGFR) by Cockcroft-Gault equation, and Child-Pugh classification score were calculated and recorded. Complete blood counts (CBC), liver function test (LFT), coagulation profile (prothrombin time (PT) and international normalized ratio (INR)), kidney function test (KFT), serum lipid profile, serology (HbsAg, Anti-hepatitis C virus (HCV) Ab, human immunodeficiency virus (HIV) 1&2), antinuclear antibody (ANA), ascitic fluid study, urine analysis, chest X-ray, Electrocardiogram (ECG) and echocardiography (patients with coronary artery disease, valvular heart disease with left ventricular (LV) systolic dysfunction or cardiomyopathy were excluded) were also done. computed tomography (CT) abdomen and upper gastrointestinal (GI) endoscopy (if indicated) were considered. The analysis was done using SPSS (trial version 23) software. A p-value < 0.05 was considered statistically significant. Results The present study enrolled 40 non-azotemic liver cirrhosis with refractory or recurrent ascites patients. In this study, after one month of treatment, there was a significant increase in urine output in the midodrine group compared with the SMT group (p-value 0.006). There was no statistical difference in model for end stage liver disease (MELD) scores after treatment among the groups. Mean arterial pressure (MAP), urine output, and glomerular filtration rate (GFR) were significantly higher in the midodrine group compared to the standard medical therapy (SMT) group after one month of treatment and were statistically significant and different. Conclusion The results of this randomized controlled trial (RCT) suggest that adding midodrine drug to the SMT group improves the systemic hemodynamics in non-azotemic cirrhotic patients with ascites, and it is also effective in lowering the body weights of the patients by decreasing the fluid accumulation. More clinical trials need to be conducted among a large number of patients before midodrine can be recommended for use in the patients.