Please select the eligibility criteria that correspond 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: Inclusion Criteria:

All adult patients who

* Undergo resuscitation in the ICU
* AND fulfillment within the previous 24 hours of the criteria for severe sepsis (SCCM/ACCP)
* AND consent is obtainable either from the patient or by proxy (physician and/or next of kin)

Exclusion Criteria:

The following patients will not be evaluated for inclusion:

* Age \< 18 years old
* Previously randomised in the 6S trial
* Allergy towards hydroxyethyl starch or malic acid
* Treatment with \> 1000 ml's of any synthetic colloid within the last 24 hours prior to randomisation
* Any form of renal replacement therapy
* Acute burn injury \> 10% body surface area
* Severe hyperkalaemia, p-K \> 6 mM
* Liver or kidney transplantation during current hospital admission
* Intracranial bleeding within current hospitalisation
* Enrollment into another ICU trial of drugs with potential action on circulation, renal function or coagulation
* Withdrawal of active therapy
B: Inclusion Criteria:

* Cirrhosis defined by clinical, laboratory or ultrasonographic findings
* Child-Pugh \> 8
* Sepsis defined by the presence of proved or suspected infection with two of the four SIRS (systemic inflammatory response syndrome) criteria (Wong F, et al. Sepsis in cirrhosis: report on the 7th meeting of the international ascites club. Gut 2005)
* Creatinine \< 160 µmol/L
* Written informed consent
* Absence of the exclusion criteria

Exclusion Criteria:

* Spontaneous bacterial peritonitis
* Difficult to treat infections such as : endocarditis, septic arthritis, osteomyelitis
* Heart insufficiency (YHA III-IV)
* Digestive bleeding during the week preceding the study
* Septic shock
* Hepatocellular carcinoma : stage D
* Use of antibiotics during the week preceding the study, except noroxin used for long-term antibioprophylaxy
* Diseases which can influence the short term survival
C: Inclusion Criteria:

* Patients with cirrhosis in the waiting list for liver transplant
* Patients with ascites or diuretic treatment
* To have written inform consent

Exclusion Criteria:

* Systolic blood pressure ≥150 mmHg and or diastolic blood pressure≥90 mmHg
* To have been treated with transjugular intrahepatic portosystemic shunt (TIPS) or surgical shunts
* Antibiotic treatment in the previous week before the inclusion in the study
* Respiratory or cardiac failure
* HIV positive
D: Inclusion Criteria:

* Cirrhosis and ascites submitted to paracentesis \> 5 liters
* Age: 18-75 years
* Informed written consent

Exclusion Criteria:

* Multinodular HCC (\> 3 nodules)
* Portal vein thrombosis
* Ongoing bacterial infection
* Ongoing or recent (less than one week) bleeding
* Cardio-pulmonary failure
* Hepatorenal syndrome type 1
* Severe coagulopathy: platelets \< 30.000/mm3 and/or PT \< 30%
* Ongoing treatment with vasoactive drugs

Answer: C