MedPath

Fall in core temperature and rewarming in severe infections

Not Applicable
Recruiting
Conditions
C01.539.757
Sepsis, hypothermia
C23.888.119.565
Registration Number
RBR-5gs5w6
Lead Sponsor
Instituto de Ciencias Biomedicas -- Universidade de Sao Paulo
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Not specified
Target Recruitment
Not specified
Inclusion Criteria

Septic patients (Sepsis-3) with core temperature of less than or equal to 35.5ºC. Both sexes; age between 18 and 120 years.

Exclusion Criteria

Patients with extensive burns (greater than 30% of body surface area), metastatic cancer, brain tumor, brain trauma, spinal cord injury, pregnancy. Patients subjected to active cooling within 24 h of the sepsis diagnosis will also be excluded, as will patients subjected to surgery within 24 h of the onset of hypothermia.

Study & Design

Study Type
Intervention
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Activation of autonomic thermoregulatory effectors, assessed by observation of shivering or sweating by the healthcare professional. Sweating will be measured by a three-point scale: (1) no sign of sweat”; (2) sweat noticed in the forehead”; (3) sweating in several body areas”. Shivering will be measured by a two-point scale: present or not noticeable. This outcome will be monitored hourly for 5 hours, starting at the onset of each episode of hypothermia.
Secondary Outcome Measures
NameTimeMethod
Thermal discomfort, assessed in non-sedated, conscious patients using a subjective 5-point scale: (1) feeling cold; (2) feeling a little chilly; (3) feeling comfortable; (4) feeling a little warm; (5) feeling hot. This outcome will be monitored hourly for 5 hours, starting at the onset of each episode of hypothermia.
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