NCT01455116

The Cooling And Surviving Septic Shock Study (CASS)

Randomized Trial to Determine Whether Mild Induced Hypothermia Can Reduce Mortality in Adult Patients With Septic Shock

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 433 (actual)
• Sponsor: Danish Procalcitonin Study Group · Academic / Other
• Sex: All
• Age: 50 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Septic Shock

Interventions

Type	Name	Description
PROCEDURE	Mild Induced Hypothermia	Induction of hypothermia to a target temperature of 32 - 34 degrees Celsius (90 - 93 degrees Fahrenheit

Timeline

• Start date: 2011-11-01
• Primary completion: 2016-11-01
• Completion: 2016-11-01
• First posted: 2011-10-19
• Last updated: 2016-11-22

Locations

11 sites across 3 countries: United States, Denmark, Netherlands