Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Midodrine and Albumin for Cirrhotic Patients in the Waiting List for Liver Transplantation
Brief Summary: The aim of this study is to evaluate the effect of prolonged administration of albumin and midodrine on the prevention of complications (renal failure, sepsis, hemorrhage, hepatic encephalopathy and hyponatremia) in patients with cirrhosis in the waiting list for liver transplantation. One hundred and ninety four patients with cirrhosis and awaiting a liver transplantation will include in the study. Patients will be randomized to receive albumin and midodrine (treatment group) or administration of placebo (saline for albumine) and tablets with excipients without midodrine (control group). Patients will be followed-up during 12th months. In the treatment group albumin will be given at a dose of 40g every 15 days and midodrine 5mg tid, in addition with lactitol (conventional doses) and the specific treatment that patients require by cirrhosis. The group control will receive placebo in the same way than the treatment group in addition with lactitol and the specific treatment that they require by their disease. In all the patients liver and renal function test, hormones determination (renin, aldosterone, noradrenaline), and cytokines will be determined in basal conditions. All these determinations will be repeated at month 1st,3rd, 6th and 12th months. Before the inclusion in the study neuropsychological test and critical flicker test will be performed to diagnose minimum EH. These tests will be repeated at 3rd, 6th and 12th months. All the determinations will be repeated at any time that the patients develop any complication considered as an end point. In baseline conditions and at 3rd and 6th months a questionnaire of quality of life (SF36) will be performed. During a year of follow-up the number of paracentesis that patients require, the incidence of renal failure and EH and their relationship with hormonal activity and cytokine levels, free transplant survival and quality of life will be recorded.


Options:
A: Arm Label: HES 130/0.4; Type: EXPERIMENTAL; Interventions: Drug: 6% Hydroxyethyl starch 130/0.4 | Arm Label: Ringer acetate; Type: ACTIVE_COMPARATOR; Interventions: Drug: Ringers acetate | Intervention Type: DRUG; Name: 6% Hydroxyethyl starch 130/0.4; Assigned to Arm(s): HES 130/0.4 | Intervention Type: DRUG; Name: Ringers acetate; Assigned to Arm(s): Ringer acetate
B: Arm Label: Usual treatment; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Human Albumin; Type: EXPERIMENTAL; Interventions: Drug: Human Albumin | Intervention Type: DRUG; Name: Human Albumin; Assigned to Arm(s): Human Albumin
C: Arm Label: Albumin plus midodrine; Type: ACTIVE_COMPARATOR; Interventions: Drug: albumin, Drug: Midodrine | Arm Label: salin solution plus pills; Type: PLACEBO_COMPARATOR; Interventions: Drug: albumin, Drug: Placebo | Intervention Type: DRUG; Name: albumin; Assigned to Arm(s): Albumin plus midodrine, salin solution plus pills | Intervention Type: DRUG; Name: Midodrine; Assigned to Arm(s): Albumin plus midodrine | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): salin solution plus pills
D: Intervention Type: DRUG; Name: albumin 4 gr/L ascites removed; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: albumin 8 gr/L ascites removed; Assigned to Arm(s): N/A

Answer: C