External Cooling in Septic Shock Patients (sepsis-cool)

Assistance Publique - Hôpitaux de Paris

Status: Completed

Conditions: Septic Shock

Treatments: Other: External cooling

Study type: Interventional

Funder types: Other

Identifiers

NCT00527007

SCR06012

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

A

Experimental group

Treatment:

Other: External cooling

B

No Intervention group