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Fall in core temperature and rewarming in severe infections

Spontaneous hypothermia and rewarming in sepsis

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-5gs5w6
Enrollment
Unknown
Registered
2020-03-17
Start date
2019-09-18
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sepsis, hypothermia

Interventions

Active rewarming (forced air) will be applied immediately when core temperature is equal or below 35.5ºC, with the goal of restoring core temperature to a value between 36.0ºC and 37.0ºC. Duration: 5
Procedure/surgery
E02.891

Sponsors

Instituto de Ciencias Biomedicas -- Universidade de Sao Paulo
Lead Sponsor
Hospital Universitário da Universidade de São Paulo
Collaborator
Hospital Universitário da Universidade Federal Fluminense
Collaborator
Hospital São José / SC
Collaborator

Eligibility

Age
18 Years to 120 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.—

Countries

Brazil

Contacts

Public ContactAlexandre Steiner

Instituto de Ciencias Biomedicas -- Universidade de Sao Paulo

asteiner@usp.br+55-11-3091-7378

Outcome results

None listed

Source: REBEC (via WHO ICTRP)