To investigate whether cooling to 33 °C for 24 hours in septic shock reduces mortality in intensive care patients.
ID
Source
Brief title
Condition
- Body temperature conditions
- Bacterial infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
All cause mortality at 30 days
Secondary outcome
1. Duration of cardiac/septic shock
2. Respiratory failure
3. Renal failure
4. Cerebral dysfunction
5. Liver failure
6. Coagulation disorders
7. Infection parameters
8. Days without organ failure up to day 30
Background summary
Septic shock patients have approximately 50% risk of death, usually related to
the development of multiple organ failure. There is evidence mild induced
hypothermia (MIH) inhibits the inflammatory response, thereby limiting organ
failure in ischemia and reperfusion injury, including cardiac arrest, stroke,
and neonatal hypoxia. Hypothermia is also applied peri-operatively to limit
ischemia reperfusion injury.
Several experimental sepsis animal models have shown improved survival when
treated with induced hypothermia. In clinical studies, patients with septic
shock cooled to normothermia had a reduced need for inotropic substances
compared to febrile patients and hypothermia improved gas exchange with a trend
towards better survival compared to group that did not receive hypothermia.
Study objective
To investigate whether cooling to 33 °C for 24 hours in septic shock reduces
mortality in intensive care patients.
Study design
Randomized, single-blinded multicenter trial.
560 ICU-patients are included in the study. All patients will receive the
standardized and recommended diagnostics and treatment used at the specific ICU
they are admitted to (Standard of care).
Furthermore, the patients are randomized to:
1. Standard-of-care: Control arm. Or 2. Mild induced hypothermia 33 °C
Intervention
Cooling to 33°C for 24 hours. The patient is subsequently rewarmed and kept
normothermic (36 °C - 38 °C) for 72 hours from start of randomization. After 72
hours, the intervention stops.
Study burden and risks
Potential benefits to the patient are decreased occurrence of organ failure,
faster shock reversal, shortened time on the ICU and lower mortality. Group
relatedness: improved treatment of sepsis. Risks associated with MIH are
potential coagulopathy, electrolyte disorders and arrhythmia. However, our
department has extensive experience with cooling patients (with cardiac
arrest), and managing the potential complications of this treatment. Moreover,
extensive coagulation measurements were performed in the first 50 patients
included in this study, showing no deterioration of coagulation status in
patients in the MIH group.
Finsencentret Blegdamsvej 9
Copenhagen DK-2100
DK
Finsencentret Blegdamsvej 9
Copenhagen DK-2100
DK
Listed location countries
Age
Inclusion criteria
- Aged 50 years or older.
- Severe sepsis/septic shock
- Admitted to the participating intensive care units (ICU)
- (Indication for) mechanical ventilation
- Possibility of inclusion within 6 hours after septic shock/severe sepsis is diagnosed in the ICU.
- Expected stay in the ICU of more than 24 hours
Exclusion criteria
- Pregnant or breast feeding
- Bleeding disorder and/or uncontrollable bleeding and /or surgery within the last 24 hours or expected surgery in the coming 12 hours
- Persons who are detained under the Act on the use of coercion in psychiatry
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT01455116 |
| CCMO | NL49105.018.14 |