Status:
TERMINATED
The Cooling And Surviving Septic Shock Study (CASS)
Lead Sponsor:
Danish Procalcitonin Study Group
Collaborating Sponsors:
TRYG Foundation
Lundbeck Foundation
Conditions:
Septic Shock
Eligibility:
All Genders
50-120 years
Phase:
PHASE2
PHASE3
Brief 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 morta...
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 ...
Eligibility Criteria
Inclusion
- Aged \> 50 years of age.
- Severe sepsis /septic shock = SIRS + suspected infection+hypotension Mean Arterial Blood Pressure (MAP) \<70 mmHg,
- Admitted to the participating intensive care units (ICU)
- Indication for intubation
- 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.
- 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
- Patients are pregnant or breast feeding
- 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
- Persons who are detained under the Act on the use of coercion in psychiatry
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2016
Estimated Enrollment :
433 Patients enrolled
Trial Details
Trial ID
NCT01455116
Start Date
November 1 2011
End Date
November 1 2016
Last Update
November 22 2016
Active Locations (11)
Enter a location and click search to find clinical trials sorted by distance.
1
Cleveland Clinic - Outcomes Research
Cleveland, Ohio, United States, 44195
2
Bispebjerg Hospital
Copenhagen, Capital Region, Denmark, 2400
3
Jens Ulrik S. Jensen
Copenhagen, Capital Region, Denmark, DK-2200
4
Gentofte Hospital
Gentofte Municipality, Capital Region, Denmark, 2900