Clinical trial NCT00527007: External Cooling in Septic Shock Patients
Official title: Impact of External Cooling in Septic Shock Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Septic Shock
Keywords: Vasopressor
Epinephrine
Norepinephrine
Cooling
Fever
ICU
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2007-09-10
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The rapidity of the resolution of cardiovascular failure has a strong impact on septic shock patients' outcome. The aim of this multicenter randomized controlled trial is to determine whether external cooling might accelerate improvement in cardiovascular function.

Detailed description: Patients suffering from septic shock need fluid resuscitation and vasopressor therapy for restoring cardiovascular function. Corticosteroids and activated protein C have been both proposed for vascular tone improvement. While external cooling is largely used in ICU febrile patients, benefits and risks of fever treatment during sepsis have been rarely studied. Surveys show that external cooling is usual care applied by nurses themselves without medical order.

The control of thermal balance might decrease cardiac output and oxygen consumption, and reduce serum lactate concentration. However some animal studies have suggested that fever might be essential for host defence. This trial compares two strategies of fever management on vasopressor dependence in septic shock patients. In the treatment group, external cooling is applied to normalize the body temperature between 36°5 C and 37°C, while control patients receive any fever treatment. The goal for mean arterial pressure is the same in the two groups and vasopressor withdrawal is determined by similar algorithm.

Eligibility criteria: Inclusion Criteria:

* Documented or suspected infection
* Body temperature \> 38.3°C
* Persistent hypotension despite fluid resuscitation and need for vasopressor infusion to maintain mean arterial pressure \> 65 mmHg.
* Invasive mechanical ventilation
* Intravenous sedation

Exclusion Criteria:

* Temperature \> 41°C
* Age \< 18 years
* Pregnancy
* Continuous renal replacement therapy
* Paracetamol or NSAI administration within 6 hours before inclusion
* Need for paracetamol and/or NSAI therapy during the study period
* Burns or Lyell syndrome

Primary outcomes:
measure: Number of patients with a decrease in the dose of vasopressors of 50% 48 hours after enrolment
timeFrame: 48 hours after enrolment
Secondary outcomes:
measure: Maximal dose of vasopressors
timeFrame: within 48 hours after enrolment
measure: SOFA score evolution
timeFrame: on Day 3, Day 7, Day 14
measure: Number of vasopressor free days in the ICU
timeFrame: during the study
Other outcomes:
Locations:
city: Creteil
country: France
facility: CHU Henri Mondor
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Frederique SCHORTGEN, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schortgen F, Charles-Nelson A, Bouadma L, Bizouard G, Brochard L, Katsahian S. Respective impact of lowering body temperature and heart rate on mortality in septic shock: mediation analysis of a randomized trial. Intensive Care Med. 2015 Oct;41(10):1800-8. doi: 10.1007/s00134-015-3987-7. Epub 2015 Jul 23.