Please select the eligibility criteria that correspond to the clinical trial below.
Title: Albumin 4 gr/L vs 8 gr/L in the Prevention of Post-Paracentesis Circulatory Dysfunction in Cirrhotic Patients With Ascites
Brief Summary: The purpose of this study is to determine whether the infusion of albumin 4 gr per liter of ascites removed is as effective as the infusion of albumin 8 gr per liter of ascites removed in the prevention of post-paracentesis circulatory dysfunction


Options:
A: 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
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

* Diagnosis of liver cirrhosis (based on clinical, laboratory, endoscopic and ultrasonographic features) and uncomplicated ascites according to the criteria of the International Ascites Club (1).
* Ongoing diuretic treatment with an anti-mineralocorticoid drug at a dose of 200 mg/day and furosemide of 25 mg/day, stable for at least 4 days prior enrollment, not inducing response (defined according to the criteria of the International Ascites Club as body weight reduction ≥ 800 grams in the 4 days prior enrollment). With this limitation, we aim to identify a fairly homogeneous population with a relatively advanced stage of the disease that will likely have more benefit from albumin administration, as also suggested by Gentilini at al. (17).
* Ongoing diuretic treatment with an anti-mineralocorticoid drug at a dose \> 200 mg/day and furosemide \> 25mg/day, independent of response to treatment.
* EGDS performed in the last 12 months, abdominal ultrasonography performed in the last 30 days, and laboratory tests required by the protocol in the last 7 days.

Exclusion criteria

* Age lower than 18 years
* No written informed consent
* Inability to follow written consent
* Established diagnosis of refractory ascites, as defined by the IAC (1)
* Need of 2 or more paracentesis during the last month
* Serum creatinine \> 1.5 mg/dl
* Organic nephropathy, as defined by the IAC (1)
* Hepatorenal syndrome type 1 in the last 15 days
* Gastrointestinal bleeding in the last 15 days
* Ongoing endoscopic eradication after a recent gastro-esophageal variceal bleeding
* Bacterial or fungal infection, including spontaneous bacterial peritonitis, in the last 7 days
* Hepatic encephalopathy grade III/IV
* Budd-Chiari Syndrome
* Patients with TIPS or other surgical porto-caval shunts
* Known and suspected active hepatocellular carcinoma or other malignancies
* Previous liver transplantation
* Ongoing alcohol abuse (patients should be abstinent for at least three months)
* Antiviral therapy for hepatitis B started in the last 6 months
* Heart failure
* Respiratory failure as defined as PO2 \<60 mmHg
* Known or suspected hypersensitivity to albumin
* Previous albumin administration given for the treatment of ascites in the last 30 days
* Patients enrolled in other clinical study for the treatment of ascites
* Use of experimental drugs for the last 2 months prior the inclusion in the present study
* Pregnancy and breast-feeding
* Females of child-bearing potential are excluded unless they meet one of the following criteria:

  * Post-menopausal for 6 months or more, and if post-menopausal for less than 2 years, a negative pregnancy test
  * Surgical sterilisation for more than one month duration and a negative pregnancy test
  * Intrauterine device in combination with a secondary barrier (e.g. diaphragm, condom or spermicide) and a negative pregnancy test
D: 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

Answer: A