Health Condition 1: K740- Hepatic fibrosis Health Condition 2: K740- Hepatic fibrosis
Conditions
Interventions
Intervention1: MIDODRINE arm: All patients will be randomized to either Standard Medical Treatment (SMT) or SMT with midodrine or SMT with clonidine.SMT was defined by restriction of sodium, treatment
Sponsors
MMCSBY scheme Government of Rajasthan
Eligibility
Inclusion criteria
Inclusion criteria: Patients with cirrhosis and refractory or recurrent ascites with stable renal function
Exclusion criteria
Exclusion criteria: Patients who did not give consent Gastrointestinal bleeding, hepatorenal syndrome, hepatic encephalopathy of grade 2 or higher Infection within 1 month preceding the study or during the study Presence of diabetes, intrinsic renal or cardiovascular disease Arterial hypertension on history and physical examination Abnormal urine analysis, chest radiograph, or electrocardiogram Presence of hepatocellular carcinoma or portal vein thrombosis Treatment with drugs with known effects on systemic and renal hemodynamics within 7 days before inclusion Non-compliance to salt restriction (=2 g/day)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary end point of the study is control of ascites. Complete response is defined as the elimination of ascites Partial response is defined as the presence of ascites not requiring paracentesis Absence of a response is defined as the persistence of ascites requiring paracentesis Timepoint: 1 month and 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end points include frequency of worsening encephalopathy, liver and renal function, and frequency of other complications of cirrhosis (e.g., variceal hemorrhage or development of hepatorenal syndrome)Timepoint: 1 month and 3 months | — |
Countries
India
Contacts
Public ContactDr Manasvin Sareen
SMS Medical College, Jaipur
Outcome results
None listed