Sepsis Clinical Trial
— INOX-SEPSISOfficial title:
Insufficient Oxygenation in Septic Patients
Verified date | May 2024 |
Source | Sanquin-LUMC J.J van Rood Center for Clinical Transfusion Research |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This study will describe the change of mitochondrial oxygen tension (mitoPO2) compared to traditional parameters of oxygenation and oxygen balance in the first 24 hours of septic patients admitted to the intensive care unit of an academic hospital. The mitoPO2 will be measured on prespecified measurement moments in the ICU. With each measurement moment, arterial and central venous blood gasses will be taken too.
Status | Completed |
Enrollment | 81 |
Est. completion date | September 28, 2023 |
Est. primary completion date | September 28, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age of patient is at least 18 years - Patients diagnosed with sepsis in the emergency department or hospital ward - Patients are admitted to the ICU via the hospital ward or emergency department - Informed 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 to a hospital ward other than the ICU after emergency department visit - Patients who cannot give informed consent themselves and without a legal representative will be excluded since no informed consent can be obtained - Patients known with porphyria and/or photodermatosis will be excluded, since 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 |
Country | Name | City | State |
---|---|---|---|
Netherlands | Leiden University Medical Center | Leiden |
Lead Sponsor | Collaborator |
---|---|
Sanquin-LUMC J.J van Rood Center for Clinical Transfusion Research | Leiden University Medical Center |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change of mitoPO2 during first 24 hours of a septic patient | The primary endpoint is the change of mitoPO2(mitochondrial oxygenation) before and after fluid therapy in patients with sepsis. This will be compared to traditional parameters used to measure tissue oxygenation and oxygen balance (central venous oxygen saturation, mean arterial pressure and lactate). | 24 hours | |
Secondary | SOFA (sequential organ failure assessment) score after 24 hours | The association of mitoPO2 change in 24 hours with the Sequential Organ Failure Assessment score after 24 hours will be assessed. With the help of this information, more insight can be given in how much information the cutaneous mitoPO2 measurement gives about the organs separately and together. | 24 hours | |
Secondary | Organ (dis)function | To describe the association between mitoPO2 change and separate organ functions. | 24 hours | |
Secondary | Validation of mitoPO2 measurement with blood based biomarkers of cellular function | Cellular function will be assessed with blood-based biomarkers mitochondrial membrane potential (MMP), presence of cellular reactive oxygen species (ROS) molecules and glutathione (GSH) activity. Mitochondrial function will be assessed with mitoPO2 measurements. | 24 hours | |
Secondary | Safety (incidence of adverse and serious adverse events) | The adverse and serious adverse events of the mitoPO2 measurements will be assessed. | 24 hours | |
Secondary | Length of ICU stay | Association of mitoPO2 change and length of intensive care unit-stay. | 3 months | |
Secondary | Length of hospital stay | Association of mitoPO2 change and length of hospital stay. | 3 months | |
Secondary | ICU mortality | Association of mitoPO2 change and intensive care unit mortality. | 3 months | |
Secondary | In-hospital mortality | Association of mitoPO2 change and in-hospital mortality. | 3 months |
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