Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Efficacy of Albumin Administration for Volume Replacement in Patients With Severe Sepsis or Septic Shock - the ALBumin Italian Outcome Sepsis (ALBIOS) Study
Brief Summary: BACKGROUND The association between mortality and hypoalbuminemia has been observed in several diseases. Nonetheless, the efficacy of albumin on survival in critically ill patients is controversial. Several meta-analyses have reported either negative, neutral, or beneficial effects of albumin administration. To clarify this controversy, a large multicenter prospective study has been performed, comparing the effects of 4% albumin vs. saline for volume replacement in critically ill patients. Although no difference in the overall mortality has been observed, a predefined subgroup analysis has shown a trend of longer survival in septic patients treated with albumin. As fluid replacement has been shown to be critical in sepsis, and based on both its primary (oncotic) and secondary properties (anti-inflammatory), it is conceivable that the use of albumin for volume replacement and for treating hypoalbuminemia may have a beneficial effects on survival of septic patients.

OBJECTIVES Primary objective: to verify whether volume replacement with albumin (treated group) and its maintenance within plasmatic physiologic range (equal or above 30 g/l) improves survival of patients with severe sepsis of septic shock, as compared to crystalloids (control group). Secondary objectives: to verify the differences in organ dysfunctions, hospital and intensive care unit (ICU) length of stay between the treated and control group.

METHODS About 1350 patients with severe sepsis or septic shock will be randomized to receive either albumin or crystalloids as fluid therapy. Volume replacement will be performed for both groups according to the early-goal directed therapy. Treated group will receive 60 gr albumin infusion after randomization, and 40-60 gr albumin daily infusion to maintain serum album level equal or above 30 g/l. Control group will receive crystalloids for the entire study; albumin administration will be allowed only when daily serum albumin level will be lower than 15 g/l. Patients will be treated until the 28th day after randomization or until ICU discharge, whichever comes first.

EXPECTED RESULTS Primary outcomes: absolute risk reduction of overall mortality of 7.5% at 28th day, with a further control at 90th day, following randomization. Secondary outcomes: reduction of number and severity of organ dysfunctions (as assessed by the Sequential Organ Failure Assessment score), reduction of ICU and hospital length of stay.


Options:
A: Arm Label: 1, Albumin and Crystalloids; Type: OTHER; Interventions: Other: Albumin and Crystalloids | Arm Label: 2, Crystalloids; Type: OTHER; Interventions: Other: Crystalloids | Intervention Type: OTHER; Name: Albumin and Crystalloids; Assigned to Arm(s): 1, Albumin and Crystalloids | Intervention Type: OTHER; Name: Crystalloids; Assigned to Arm(s): 2, Crystalloids
B: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Drug: 7.5% hypertonic saline/6% Dextran-70 (HSD) | Arm Label: 2; Type: EXPERIMENTAL; Interventions: Drug: 7.5% hypertonic saline (HS) | Arm Label: 3; Type: PLACEBO_COMPARATOR; Interventions: Drug: 0.9% normal saline | Intervention Type: DRUG; Name: 7.5% hypertonic saline/6% Dextran-70 (HSD); Assigned to Arm(s): 1 | Intervention Type: DRUG; Name: 7.5% hypertonic saline (HS); Assigned to Arm(s): 2 | Intervention Type: DRUG; Name: 0.9% normal saline; Assigned to Arm(s): 3
C: Arm Label: 7.5% hypertonic saline/6% dextran (HSD); Type: EXPERIMENTAL; Interventions: Drug: 7.5% Hypertonic Saline in 6% Dextran-70 (HSD) | Arm Label: 7.5% hypertonic saline (HS); Type: EXPERIMENTAL; Interventions: Drug: 7.5% Hypertonic Saline (HS) | Arm Label: 0.9% normal saline (NS); Type: PLACEBO_COMPARATOR; Interventions: Drug: 0.9% Normal Saline (NS) | Intervention Type: DRUG; Name: 7.5% Hypertonic Saline in 6% Dextran-70 (HSD); Assigned to Arm(s): 7.5% hypertonic saline/6% dextran (HSD) | Intervention Type: DRUG; Name: 7.5% Hypertonic Saline (HS); Assigned to Arm(s): 7.5% hypertonic saline (HS) | Intervention Type: DRUG; Name: 0.9% Normal Saline (NS); Assigned to Arm(s): 0.9% normal saline (NS)
D: Intervention Type: DRUG; Name: 10% Hemohes® (10% Hydroxyethyl starch); Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: Sterofundin® (Ringer lactate solution); Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: Actrapid® (Insulin); Assigned to Arm(s): N/A

Answer: A