Septic Shock Clinical Trial
Official title:
Randomized Trial to Determine Whether Mild Induced Hypothermia Can Reduce Mortality in Adult Patients With Septic Shock
Septic shock is in critically ill patients is a condition associated with a high rate of organ failure and hereto attributable mortality ~45-55% Hypothesis: Mild Induced Hypothermia reduces the mortality of critically ill patients with septic shock by reducing organ metabolism, counteracting on microcirculatory thrombosis, genetically downregulating tissue apoptosis and by reducing bacterial growth rate and toxin production.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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