Impact of External Cooling in Septic Shock Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 200
- Locations
- 2
- Primary Endpoint
- Number of patients with a decrease in the dose of vasopressors of 50% 48 hours after enrolment
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Number of patients with a decrease in the dose of vasopressors of 50% 48 hours after enrolment
Time Frame: 48 hours after enrolment
Secondary Outcomes
- Maximal dose of vasopressors(within 48 hours after enrolment)
- SOFA score evolution(on Day 3, Day 7, Day 14)
- Number of vasopressor free days in the ICU(during the study)