Insufficient oxygenation in septic patients: the INOX Sepsis Study

Completed

Conditions: blood poisoning
sepsis
10019815

Registration Number: NL-OMON55764

Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary: Trial ended prematurely

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 72

Inclusion Criteria

- Age of patient is at least 18 years
- Patients diagnosed with sepsis in the emergency department or hospital ward,
including patients with possible COVID-19
- Patients are admitted to the ICU via the hospital ward or emergency department
- Informed or deferred consent is given either by the patient or if the patient
is too ill to give informed consent, by his or her legal representative
- Patients have an arterial catheter in situ, since blood samples will be taken
for the study. Most patients admitted to the ICU have an arterial catheter in
place since it is part of standard care.

Exclusion Criteria

-Patients younger than 18 years
-Patients with sepsis discharged after emergency department visit
-Patients admitted with sepsis to a hospital ward other than the ICU after
emergency department visit
-Patients without a legal representative will be excluded since no informed
consent can be given
-Patients known with porphyria and/or photodermatosis will be excluded, due to
the risk of phototoxicity
-Patients with hypersensitivity to the active substance or to the plaster
material of ALA (5-aminolevulinic acid)
-Pregnant or breast feeding women since there is no adequate data form the use
of ALA in pregnant or breast feeding women
-Insufficient comprehensibility of the Dutch language

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Change in mitoPO2 before and after fluid therapy. This will be compared to<br /><br>traditional parameters used to measure oxygenation and oxygen balance</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints:<br /><br>- Association of mitoPO2 change with separate (ischemic) organ (dis)function<br /><br>and the SOFA score after 24 hours<br /><br>- Safety of mitoPO2 measurements in critically ill septic patients<br /><br>- Description of the association between mitoPO2 change and clinical outcomes,<br /><br>like length of stay (both ICU and in-hospital) and mortality (both ICU and<br /><br>in-hospital)<br /><br>- Association between mitoPO2 and severity of sepsis to immune parameters such<br /><br>as plasma cytokines and cellular phenotypes.<br /><br>- Description of the level of hypoxia, including mitoPO2, in critically ill<br /><br>patients with sepsis due to COVID-19.</p><br>