Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Role of Midodrine and Tolvaptan in Patients With Cirrhosis With Refractory or Recurrent Ascites
Brief Summary: The development of ascites in the natural history of cirrhosis heralds a worsening of the prognosis to 50% survival at 2 years, and this deteriorates to 30-50% at 1 year when the ascites becomes refractory to medical therapy. Hemodynamic alterations and their relation to neurohumoral systems are essential in pathophysiology of ascites formation. The theory that best explain the ascites formation and sodium retention in cirrhotics is portal hypertension leading to splanchnic arterial vasodilatation leading to underfilling of arterial circulation which is sensed by the arterial and the cardiopulmonary receptors leading to sympathetic nervous system activation and activation of the anti-natriuretic factors (RAAS and arginine vasopressin), resulting in sodium and water retention. The therapeutic options available for patients with refractory ascites are serial therapeutic paracentesis, liver transplantation and transjugular intrahepatic portosystemic shunts.Vasopressin V2 receptor antagonists antagonize the antidiuretic effects of vasopressin at the V2 receptor located in the renal collecting duct, they increase free water clearance, and thus may be helpful in mobilizing excess water in conditions associated with water retention including cirrhosis. The use of V2 receptor antagonists in cirrhosis with ascites has been shown to be safe and efficacious. Midodrine, an alpha adreno receptor agonist by causing splanchnic vasoconstriction has been used in hepatorenal syndrome (HRS) and for control of ascites in patients with refractory or recurrent ascites. It is possible that vasoconstrictors and aquaretics (V2 receptor antagonists) by acting at different sites in combination may reverse some of the pathogenic events that results in refractory or recurrent ascites.There are no reports on the use of combination of midodrine and tolvaptan in the patients with cirrhosis with ascites. Therefore, we plan to study the role of midodrine, tolvaptan and their combination on systemic hemodynamics, renal functions and control of ascites in patients with cirrhosis and refractory or recurrent ascites.


Options:
A: Arm Label: Standard medical treatment plus albumin; Type: ACTIVE_COMPARATOR; Interventions: Drug: Diuretics plus human albumin | Arm Label: Standard medical treatment; Type: OTHER; Interventions: Drug: Diuretics (standard medical treatment) | Intervention Type: DRUG; Name: Diuretics plus human albumin; Assigned to Arm(s): Standard medical treatment plus albumin | Intervention Type: DRUG; Name: Diuretics (standard medical treatment); Assigned to Arm(s): Standard medical treatment
B: Arm Label: Albumin (Control group); Type: ACTIVE_COMPARATOR; Interventions: Drug: Albumin, Drug: Oral tablet (Midodrine placebo), Drug: Saline injection (Octreotide LAR placebo), Procedure: Large Volume Paracentesis | Arm Label: Vasoconstrictor (Study Group); Type: EXPERIMENTAL; Interventions: Drug: Intravenous Saline Infusion (Albumin placebo), Drug: Midodrine, Drug: Octreotide LAR, Procedure: Large Volume Paracentesis | Intervention Type: DRUG; Name: Albumin; Assigned to Arm(s): Albumin (Control group) | Intervention Type: DRUG; Name: Intravenous Saline Infusion (Albumin placebo); Assigned to Arm(s): Vasoconstrictor (Study Group) | Intervention Type: DRUG; Name: Midodrine; Assigned to Arm(s): Vasoconstrictor (Study Group) | Intervention Type: DRUG; Name: Oral tablet (Midodrine placebo); Assigned to Arm(s): Albumin (Control group) | Intervention Type: DRUG; Name: Octreotide LAR; Assigned to Arm(s): Vasoconstrictor (Study Group) | Intervention Type: DRUG; Name: Saline injection (Octreotide LAR placebo); Assigned to Arm(s): Albumin (Control group) | Intervention Type: PROCEDURE; Name: Large Volume Paracentesis; Assigned to Arm(s): Albumin (Control group), Vasoconstrictor (Study Group)
C: Arm Label: Standard medical therapy; Type: ACTIVE_COMPARATOR; Interventions: Drug: Standard medical therapy | Arm Label: Midodrine group; Type: ACTIVE_COMPARATOR; Interventions: Drug: Standard medical therapy, Drug: Midodrine | Arm Label: Tolvaptan group; Type: ACTIVE_COMPARATOR; Interventions: Drug: Standard medical therapy, Drug: Tolvaptan | Arm Label: Tolvaptan plus midodrine arm; Type: EXPERIMENTAL; Interventions: Drug: Standard medical therapy, Drug: Tolvaptan, Drug: Midodrine | Intervention Type: DRUG; Name: Standard medical therapy; Assigned to Arm(s): Midodrine group, Standard medical therapy, Tolvaptan group, Tolvaptan plus midodrine arm | Intervention Type: DRUG; Name: Tolvaptan; Assigned to Arm(s): Tolvaptan group, Tolvaptan plus midodrine arm | Intervention Type: DRUG; Name: Midodrine; Assigned to Arm(s): Midodrine group, Tolvaptan plus midodrine arm
D: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Procedure: TIPS | Arm Label: 2; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Paracenthese | Intervention Type: PROCEDURE; Name: TIPS; Assigned to Arm(s): 1 | Intervention Type: PROCEDURE; Name: Paracenthese; Assigned to Arm(s): 2

Answer: C