The Cooling And Surviving Septic Shock Study (CASS)

NCT01455116 | Terminated Phase 2 DMC

• 1 other identifier: H-A-2008-086
• Study Type: interventional
• Target: 433
• Locations: 3 countries
• Sites: 11

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 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.

Conditions

Septic Shock

Keywords

Sepsis; Multi organ dysfunction syndrome; Mild Induced Hypothermia

Outcome Measures

Primary Outcomes (1)

• Mortality

  All cause

  30 days

Secondary Outcomes (8)

• Renal failure

  30 days

• Respiratory

  30 days

• Circulatory breakdown/Septic Shock

  Measure on day 4

• Cerebral dysfunction

  Day 1-4

• Hepatic Failure

  Days 1-4

Study Arms (2)

Mild induced hypothermia

EXPERIMENTAL

Induced hypothermia to 32-34 degrees Celsius (90 - 93 degrees Fahrenheit)

Procedure: Mild Induced Hypothermia

Fever Respect

NO INTERVENTION

Standard of care septic shock therapy according to Surviving Sepsis Campaign guidelines

Interventions

Mild Induced Hypothermia PROCEDURE

Induction of hypothermia to a target temperature of 32 - 34 degrees Celsius (90 - 93 degrees Fahrenheit

Also known as: Cooling

Mild induced hypothermia

Eligibility Criteria

• Age: 50 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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
• 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

Sponsors & Collaborators

• Danish Procalcitonin Study Group: lead
• TRYG Foundation: collaborator
• Lundbeck Foundation: collaborator

Study Sites (11)

Cleveland Clinic - Outcomes Research

Cleveland, Ohio, 44195, United States

Location

Bispebjerg Hospital

Copenhagen, Capital Region, 2400, Denmark

Location

Jens Ulrik S. Jensen

Copenhagen, Capital Region, DK-2200, Denmark

Location

Gentofte Hospital

Gentofte Municipality, Capital Region, 2900, Denmark

Location

Herlev Hospital

Herlev, Capital Region, 2730, Denmark

Location

Nordsjællands Hospital, Hillerød

Hillerød, Capital Region, 3400, Denmark

Location

Aarhus University Hospital, Skejby

Aarhus, Jutland, 8200, Denmark

Location

Horsens Hospital

Horsens, Jutland, Denmark

Location

Køge Hospital

Køge, Region Sealand, 4600, Denmark

Location

Roskilde Hospital

Roskilde, Region Sealand, 4000, Denmark

Location

Academic Medical Center

Amsterdam, Netherlands

Location

Related Publications (2)

• Itenov TS, Johansen ME, Bestle M, Thormar K, Hein L, Gyldensted L, Lindhardt A, Christensen H, Estrup S, Pedersen HP, Harmon M, Soni UK, Perez-Protto S, Wesche N, Skram U, Petersen JA, Mohr T, Waldau T, Poulsen LM, Strange D, Juffermans NP, Sessler DI, Tonnesen E, Moller K, Kristensen DK, Cozzi-Lepri A, Lundgren JD, Jensen JU; Cooling and Surviving Septic Shock (CASS) Trial Collaboration. Induced hypothermia in patients with septic shock and respiratory failure (CASS): a randomised, controlled, open-label trial. Lancet Respir Med. 2018 Mar;6(3):183-192. doi: 10.1016/S2213-2600(18)30004-3. Epub 2018 Jan 8.

  PMID: 29325753 DERIVED

• Johansen ME, Jensen JU, Bestle MH, Ostrowski SR, Thormar K, Christensen H, Pedersen HP, Poulsen L, Mohr T, Kjaer J, Cozzi-Lepri A, Moller K, Tonnesen E, Lundgren JD, Johansson PI. Mild induced hypothermia: effects on sepsis-related coagulopathy--results from a randomized controlled trial. Thromb Res. 2015 Jan;135(1):175-82. doi: 10.1016/j.thromres.2014.10.028. Epub 2014 Nov 5.

  PMID: 25466837 DERIVED

MeSH Terms

Conditions

Shock, Septic; Sepsis

Interventions

Hypothermia, Induced; Cool-Down Exercise

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

Cryotherapy; Therapeutics; Post-Exercise Recovery Techniques; Physical Therapy Modalities; Rehabilitation; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Jens Ulrik S Jensen, MD, PhD

  CHIP & PERSIMUNE, Rigshospitalet, University of Copenhagen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2011
• First Posted: October 19, 2011
• Study Start: November 1, 2011
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: November 22, 2016

Record last verified: 2016-11

Locations

DK (9); NL (1); US (1)