ImmunoModulation effects of early therapeutic NORMothermia in febrile severe Septic patients

Phase 2

Completed

• Conditions: cytokines; CD11b; Sepsis; sepsis; therapeutic normothermia; fever control; immunomodulation; neutrophil chemotaxis; mHLA- DR

• Registration Number: TCTR20160321001
• Lead Sponsor: Faculty of Medicine, Chulalongkorn University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03-21
• Study Completion: 2016-11-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 15

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
feasibility 0-24 hours more than 80% of the time point during intervention that the temperature could be controlled under 3

Secondary Outcome Measures

Name	Time	Method
mortality rate 14 and 28 day mortality rate,organ dysfunction 7&#44; 14 and 28 day SOFA score,lactate clearance 1&#44; 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&#45;24 hours temperature ,immunomodulation effect 0&#44;24&#44;72 hours neutrophil chemotaxis&#44; mHLA&#45;DR&#44; CD11b&#44; IL&#45;6&#44; IL&#45;10&#44; 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&#45;24 hours shivering score,new arrhythmia 0&#45;24 hours incidence,intractable hyperglycemia 0&#45;24 hours incidence,hypothermia < 36 C 0&#45;24 hours incidence