Please select the eligibility criteria that correspond to the clinical trial below.
Title: CRISTAL: Colloids Compared to Crystalloids in Fluid Resuscitation of Critically Ill Patients: A Multinational Randomised Controlled Trial
Brief Summary: Background: Two recent systematic reviews of the literature and meta-analyses have suggested that colloids administration might be deleterious in critically ill patients.

Objective: To compare the effects on hospital mortality of crystalloids and colloids when given for fluid resuscitation in critically ill patients.

Setting: Adult intensive care units (ICUs) in several European countries.

Study design: A multinational, randomised, controlled trial performed on two parallel groups.

Intervention: Any type of crystalloids (control group) versus any type of colloids (including albumin).

Patients: All patients above the legal age of consent and hospitalised in an intensive care unit, who need fluid resuscitation (according to the physician). Pregnant women, moribund patients, brain dead patients, and patients who have a known allergy to colloids or severe head injury or major burns (\> 20% of body surface) or dehydration will not be included.

Primary endpoint: 28-day mortality.

Hypothesis: Assuming a hospital mortality rate of 20% in the crystalloids group, a 0.05 type I error, 3010 patients are needed to show a difference between the 2 groups of 5% with a 90% probability (two-sided test).


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:

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
D: Inclusion Criteria:

* Males and females, above the legal age of consent
* Hospitalized in intensive care unit
* Need fluid resuscitation (according to the physician in charge of the patient)

Exclusion Criteria:

Patients who have one or more of the following items:

* Known allergy to gelatins, albumin or starch
* Coagulation disorders (haemophilia, Willebrand disease, etc.)
* Chronic renal failure on permanent dialysis
* Severe hepatic failure
* Burns \> 20 % of body surface
* Pregnancy
* Volume replacement: As a part of anaesthesia, for anaphylactic shock, or for dehydration
* Brain death
* Advance directive of withholding or withdrawal of life-sustaining treatments
* Any other investigational drugs

Answer: D