The Cooling And Surviving Septic Shock Study (CASS)

Stopped early · Phase 2/Phase 3

Conditions studied: Septic Shock

In brief

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.

Key facts

Study ID

NCT01455116

Run by

Danish Procalcitonin Study Group

People needed

433

Starts

2011-11-01

Expected to finish

2016-11-01

Last updated by the study team

2016-11-22

Who can join

Age: 50 and older, up to 120. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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

Where it is running

• Cleveland Clinic - Outcomes Research — Cleveland, Ohio, United States
• Bispebjerg Hospital — Copenhagen, Capital Region, Denmark
• Jens Ulrik S. Jensen — Copenhagen, Capital Region, Denmark
• Gentofte Hospital — Gentofte Municipality, Capital Region, Denmark
• Herlev Hospital — Herlev, Capital Region, Denmark
• Nordsjællands Hospital, Hillerød — Hillerød, Capital Region, Denmark
• Aarhus University Hospital, Skejby — Aarhus, Jutland, Denmark
• Horsens Hospital — Horsens, Jutland, Denmark
• Køge Hospital — Køge, Region Sealand, Denmark
• Roskilde Hospital — Roskilde, Region Sealand, Denmark
• Academic Medical Center — Amsterdam, Netherlands

Full record on ClinicalTrials.gov

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