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Temperature Optimization in Afebrile Septic PatienTs

ConditionsSepsisTemperature
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMatt Harmon

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Sepsis according to the SEPSIS-3 definition

Sedated and intubated

Highest temperature < 38,3 degrees Celsius

Disqualifiers

human immunodeficiency virus

neutropenia

history of chronic infection with hepatitis B or C virus

treatment with corticosteroids at a dose of > 300 mg/day hydrocortisone or equivalent at the time of enrollment;

Trial design

Design model

Parallel

Treatments tested in this trial

  • External Warming

    Other intervention

    External Warming with the Arctic Sun 5000

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: External WarmingExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Proteomics

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

Time frame
From enrollment until 48 hours after enrollment

Secondary outcomes

1

Mortality

The effect of external warming of afebrile septic patients on mortality

Time frame
30 days
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Matt Harmon

Lead sponsor

Erasmus Medical Center

Sponsor institution

BD Technologies, Research Triangle Park, NC

Collaborator

Source ClinicalTrials.gov
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