Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Effects of Intravenous Albumin Administration on Renal Function and Survival in Patients With Cirrhosis and Infections Unrelated to Spontaneous Bacterial Peritonitis. A Prospective, Stratified, Randomized and Controlled Study.
Brief Summary: Spontaneous bacterial peritonitis (SBP) present in cirrhotic patients induces severe circulatory dysfunction, which results in renal failure in up to 30% of the patients. Renal failure is an important prognostic marker, representing the major predictive factor of in-hospital mortality.

Recent studies have shown that plasma volume expansion with albumin associated with cefotaxime in patients with SBP is more efficient to prevent renal failure than cefotaxime treatment alone. The in-hospital and three-month mortality rates, furthermore, were significantly lower in the group treated with albumin.

It is not known if other bacterial infections unrelated to SBP represent a risk factor for the development of renal failure among cirrhotic patients. The researcher's group has recently performed a study to evaluate the incidence, characteristics and outcome, of renal failure in patients with cirrhosis and bacterial infections unrelated to SBP associated with the systemic inflammatory response syndrome (Terra, unpublished results). Among a total of 106 patients, 29 (27%) presented renal failure during the course of infection. Renal failure was characterized by intense renal vasoconstriction (intrarenal resistive index of 0.83 +/- 0.09, measured by Doppler ultrasound), reduction of mean arterial pressure and an important activation of endogenous vasoconstriction systems. The three-month survival probability of patients with infection and renal failure was 34 %, much lower than that of patients with infection but not presenting renal failure (87%, p\<0.0001). These results suggest that the development of renal failure in patients with cirrhosis and bacterial infections different from SBP, associated with signs of a systemic inflammatory response, is very frequent and results in a very poor prognosis. Taken as a whole, these data strongly indicate the need to consider these patients as candidates for liver transplantation and to plan strategies for its prevention.

The objective of this project, therefore, is to evaluate if the plasma volume expansion with albumin, associated with conventional antibiotic therapy, can prevent the development of renal failure and increase survival rates in cirrhotic patients with bacterial infections unrelated to spontaneous bacterial peritonitis.


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: Arm Label: 1; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: 2; Type: ACTIVE_COMPARATOR; Interventions: Drug: Human Albumin | Intervention Type: DRUG; Name: Human Albumin; Assigned to Arm(s): 2

Answer: D