Sepsis sepsis therapeutic normothermia fever control immunomodulation neutrophil chemotaxis cytokines CD11b mHLA-
Conditions
Interventions
Therapeutic normothermia with goal of body temperature 36-
degree Celsius for 24 hours,
using active external physical cooling device ,Standard treatment of fever using acetaminophen when body temperature more than 39.5-
degree Celsius
Experimental Other,Active Comparator Other
Therapeutic normothermia,Standard treatment
Sponsors
Faculty of Medicine, Chulalongkorn University
Faculty of Medicine,
Chulalongkorn University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Diagnosis of severe sepsis by the definition of Surviving Sepsis Campaign Guideline 2012 2. Body temperature more than 38.3 degree-Celsius 3. Serum lactate > 4mmol/L or systolic blood pressure less than 90 mmHg after 1 litres of intravenous fluid or need vasopressor to maintain systolic blood pressure more than 90 mmHg
Exclusion criteria
Exclusion criteria: 1. expected to be deceased within 24 hours 2. Terminally ill patients that do not want to be resuscitated 3. Causative organism suspected to be from other organisms other than bacteria 4. Pregnant patients 5. Immunocompromised such as HIV, post-splecnectomy, neutropenia, on immunosupressive agent 6. Transferred from other hospitals 7. Diagnosis of severe sepsis more than 12 hours 8. Patients with acute brain injury
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| feasibility 0-24 hours more than 80% of the time point during intervention that the temperature could be controlled under 3 | — |
Secondary
| Measure | Time frame |
|---|---|
| mortality rate 14 and 28 day mortality rate,organ dysfunction 7, 14 and 28 day SOFA score,lactate clearance 1, 7 day lactate,mechanical ventilation free day during admission day without mechanical ventilation,duration of vasopressor use during admission duration of vasopressor use : hours ,temperature difference between groups 0-24 hours temperature ,immunomodulation effect 0,24,72 hours neutrophil chemotaxis, mHLA-DR, CD11b, IL-6, IL-10, CRP,hospital length of stay during admission length of stay,major bleeding during admission major bleeding criteria,secondary infection during admission secondary infection,shivering 0-24 hours shivering score,new arrhythmia 0-24 hours incidence,intractable hyperglycemia 0-24 hours incidence,hypothermia < 36 C 0-24 hours incidence | — |
Contacts
Public ContactJutamas Saoraya
Department of Emergency Medicine, Faculty of Medicine, Chulalaongkorn University
Outcome results
None listed