Please select the eligibility criteria that correspond 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: Inclusion Criteria:

* Patients with severe sepsis or septic shock, if each one of the following criteria is satisfied:

  * Proved or suspected infection in at least one site:

    * lung
    * abdomen
    * genito-urinary tract
    * other (blood, skin and soft tissue, central nervous system, bones and joints, cardiac system, catheter-related infection, other)
  * Two or more of the following:

    * a core temperature ≥ 38° C o ≤ 36° C
    * a heart rate ≥ 90 beats/min
    * a respiratory rate ≥ 20 breaths/min or PaCO2 ≤ 32 mmHg or use of mechanical ventilation for an acute process
    * a white blood cell count ≥ 12000/ml or ≤ 4000/ml or immature neutrophils \> 10%
  * Presence of at least a severe organ dysfunction, as measured by the modified Sequential Organ Failure Assessment (SOFA) score:

    * respiratory score \> 1
    * hematologic score \> 1
    * hepatic score \> 1
    * cardiovascular score equal to 1, 3 or 4
    * renal score \> 1

Exclusion Criteria:

* Age below 18 years
* Terminal state
* Known adverse reaction to albumin administration
* Severe sepsis or septic shock in patients after proved or suspected head injury, clinically active
* Congestive heart failure (NYHA score III and IV)
* Pathological conditions in which albumin administration is clinically indicated (hepatic cirrhosis with ascites, intestinal malabsorption syndrome, nephritic syndrome, burns)
* More than 24 hours since inclusion criteria were met
* Religious objection to the administration of human blood products
* Inclusion in other experimental study
B: Inclusion Criteria:

* Blunt or penetrating trauma
* Prehospital Systolic Blood Pressure (SBP) \<= 70;OR
* Prehospital SBP 71-90 AND Hear Rate (HR) ≥108
* 15 years of age or older, or 50kg or more if age unknown

Exclusion Criteria:

* Known or suspected pregnancy
* Age younger than 15 or less than 50kg if age unknown
* Ongoing prehospital cardiopulmonary resuscitation (CPR)
* Administration of more than 2000cc crystalloid or any colloid or blood products
* Severe hypothermia (suspected Temperature less than 28 degrees celsius)
* Drowning or asphyxia due to hanging
* Burns Total Body Surface Area (TBSA) more than 20%
* Isolated penetrating injury to the head
* Inability to obtain prehospital intravenous access
* Time of call received at dispatch to study intervention greater than four hours
* Known prisoners
C: Inclusion Criteria:

* Blunt trauma
* Pre-hospital Glasgow Coma Scale equal to or less than 8(GCS≤8)\*
* Age 15 years or older or 50 kg or more

  * Patients who met the inclusion criteria above and did not meet the exclusion criteria below but who had systolic blood pressure (SBP) ≤70 or SBP\>70 and SBP≤90 and heart rate (HR)≥108 were included in the Hypertonic Resuscitation following Traumatic Injury study that focused on shock patients who may or may not have a traumatic brain injury (TBI). In other words, patients with both TBI and shock would not be included in this study of TBI patients without shock at the time of enrollment.

Exclusion Criteria:

* Known or suspected pregnancy
* Age younger than 15 years or less than 50 kg if age unknown
* Ongoing pre-hospital cardiopulmonary resuscitation (CPR)
* Administration of more than 2L crystalloid or any colloid or blood products
* Severe hypothermia (T less than 28C)
* Drowning or asphyxia due to hanging
* Burns TBSA more than 20%
* Isolated penetrating injury to the head
* Inability to obtain pre-hospital intravenous access
* Time of call received at dispatch to study intervention more than four hours
* Known prisoners
D: Inclusion Criteria:

* Patients fulfilling the criteria of "severe sepsis" or "septic shock" according to the Society of Critical Care Medicine/American College of Chest Physicians (SCCM/ACCP) definitions not longer than 24 hours before ICU admission or 12 hours after ICU admission

Exclusion Criteria:

* Age \< 18 years
* Pregnancy
* Known allergy against hydroxyethyl starch
* Pre-treatment with \> 1000ml hydroxyethyl starch within 24 hours before inclusion
* Pre-existing kidney failure requiring dialysis or serum creatinine value \> 320 mmol/l (3,6 mg/dl)
* Intracerebral hemorrhage
* Severe head trauma with edema
* FiO2 at time of study inclusion \> 0,7
* Heart failure (New York Heart Association \[NYHA\] IV)
* Enrolment in another interventional study
* Immune suppression (cytostatic chemotherapy, steroid therapy, AIDS)
* Do not resuscitate (DNR) order

Answer: A