Temperature Optimization in Afebrile Septic PatienTs

Matt Harmon50 enrolled

Overview

The goal of this interventional study is to learn if external warming works to treat patients with a serious systemic infection (i.e. sepsis) that do not have fever. These patients have a higher risk of dying than patients with fever. It is possible that these patients might benefit from artificial external warming with the means to increase body temperature. It is unknown what the mechanism is, but it might be related to the immune system and how the body manages blood pressure and perfusion. The main questions to answer are: * Does external warming of the body influence certain inflammatory proteins in the blood? * Does external warming of the body influence prognosis and/or clinical condition? Researchers will compare external warming to standard clinical practice to see if external warming works to treat sepsis without fever. Participants will: \- receive treatment with external warming or treatment according to clinical practice

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Sepsis Temperature

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Sepsis according to the SEPSIS-3 definition * Sedated and intubated * Highest temperature \< 38,3 degrees Celsius Exclusion Criteria: A potential participant who meets any of the following criteria will be excluded from participation in this study: * Patients with immunologic diseases: * human immunodeficiency virus * neutropenia * history of chronic infection with hepatitis B or C virus Patients using immune suppressing medications: * treatment with corticosteroids at a dose of \> 300 mg/day hydrocortisone or equivalent at the time of enrollment; * Tacrolimus * Mycophenolate mofetil * Ciclofosfamide Patients with a contraindication for therapeutic hyperthermia: * cardiac arrest * acute ischemic stroke * acute coronary syndrome * traumatic brain injury * spinal cord injury * sickle cell disease * multiple sclerosis * Pregnancy * Moribund patients (expected death within 48 hours) * Contraindications to forced air warming devices per manufacture instructions (i.e. ischemic limbs)

Outcomes

Primary Outcomes

Proteomics

Delta proteomics pathway analysis between baseline and after 48 hours of enrollment.

Time frame: From enrollment until 48 hours after enrollment

Secondary Outcomes

Mortality

The effect of external warming of afebrile septic patients on mortality

Time frame: 30 days

Organ failure

To assess the effect of external warming of afebrile septic patients on organ failure.

Time frame: until end of ICU stay, approximately 30 days

Length of ICU stay

To assess the effect of external warming of afebrile septic patients on length of ICU-stay

Time frame: until end of ICU stay, approximately 30 days

Nosocomial infections

To assess the effect of external warming of afebrile septic patients on nosocomial infections.

Time frame: until end of ICU stay, approximately 30 days

Length of hospital stay

To assess the effect of external warming of afebrile septic patients on length of ICU-stay

Time frame: until discharge, approximately 30 days until 3 months

Microcirculation

To assess the impact of therapeutic hyperthermia in afebrile septic patients on microcirculation measured sublingually

Time frame: From enrollment until 48 hours after enrollment

Hemodynamics

To assess the impact of external warming in afebrile septic patients on hemodynamics

Time frame: From enrollment until 48 hours after enrollment

Mitochondrial oxygen tension

To assess the impact of external warming in afebrile septic patients on mitochondrial oxygen tension

Time frame: From enrollment until 48 hours after enrollment

Temperature Optimization in Afebrile Septic PatienTs

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts