Status:
COMPLETED
Insufficient Oxygenation in Septic Patients
Lead Sponsor:
Sanquin-LUMC J.J van Rood Center for Clinical Transfusion Research
Collaborating Sponsors:
Leiden University Medical Center
Conditions:
Sepsis
Critical Care
Eligibility:
All Genders
18+ years
Brief Summary
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 ...
Detailed Description
Evidence is increasing that there is no clear parameter for tissue oxygenation in critically ill septic patients to guide resuscitation. New studies have shown the potential of protoporphyrin IX-tripl...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 13 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 28 2023
Estimated Enrollment :
81 Patients enrolled
Trial Details
Trial ID
NCT03842722
Start Date
February 13 2019
End Date
September 28 2023
Last Update
May 8 2024
Active Locations (1)
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1
Leiden University Medical Center
Leiden, Netherlands, 2333 ZA