The Cooling And Surviving Septic Shock Study (CASS)

Septic shock is an acute life-threatening condition, with great organ damage for every hour.
The patients have a high risk of dying and therefore rapid treatment is of crucial
importance for survival of the patients.

Septic shock is mainly due to a collapse in the blood circulation (the capillary system) due
to blockage by blood cells - a process initiated by substances from the cells of the immune
system via activation of coagulation. The normal function of the smallest blood vessels is
to transport oxygen, nutrients and drugs to organs and tissues, and lead waste products
away. While the offer of oxygen and nutrients to the organs decreases, the consumption of
oxygen and nutrients increases due to fever and immune reactions.

When the capillary system collapses, the organs and tissues suffer, and various forms of
cell death in the organs begins including "programmed cell death" ("apoptosis"). This leads
to organ damage, for example brain damage or kidney damage and ultimately to multiple organ
dysfunction which is the direct cause of the patient dies.

Mild induced hypothermia (cooling to 32 0C-34 0C) affects at least 5 core areas in the
pathophysiology of septic shock: 1) inhibition of inflammation 2) inhibition of apoptosis
("programmed cell death"), 3) antithrombotic, 4) decreases the metabolism and 5) inhibits
bacterial growth and production of toxins.

Inclusion Criteria:

1. Aged > 50 years of age.

2. Severe sepsis /septic shock = SIRS + suspected infection+hypotension Mean Arterial
Blood Pressure (MAP) <70 mmHg,

3. Admitted to the participating intensive care units (ICU)

4. Indication for intubation

5. Possibility of inclusion within 6 hours after septic shock/severe sepsis is diagnosed
in the ICU. Patients admitted with septic shock/severe sepsis should be included
within 6 hours after admission. If a patient is not included within this period, that
patient cannot be included within the same hospitalization.

6. The patient must have an expected stay in the ICU of more than 24 hours. Anticipated
death within 24 hours after admission to the ICU does not exclude participation;
however no decision of reduction of treatment level must have been taken. During this
time period, probability that the patient is discharged to a floor department must
not be likely (<10% probability).

Exclusion Criteria:

1. Patients are pregnant or breast feeding

2. The findings of the initial screening, shows that the patient has a bleeding disorder
and/or the patient has an uncontrollable bleeding and /or surgery within the last 24
hours

3. Persons who are detained under the Act on the use of coercion in psychiatry