1. To describe mitoPO2 in clinically admitted critically ill septic patients receiving fluid therapy (consisting of crystalloid, albumin and/or red cell transfusion).2. To describe the effects of fluid therapy on mitoPO2 and on other physiological…
ID
Source
Brief title
Condition
- Hepatobiliary neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Change in mitoPO2 before and after fluid therapy. This will be compared to
traditional parameters used to measure oxygenation and oxygen balance
Secondary outcome
Secondary endpoints:
- Association of mitoPO2 change with separate (ischemic) organ (dis)function
and the SOFA score after 24 hours
- Safety of mitoPO2 measurements in critically ill septic patients
- Description of the association between mitoPO2 change and clinical outcomes,
like length of stay (both ICU and in-hospital) and mortality (both ICU and
in-hospital)
- Association between mitoPO2 and severity of sepsis to immune parameters such
as plasma cytokines and cellular phenotypes.
- Description of the level of hypoxia, including mitoPO2, in critically ill
patients with sepsis due to COVID-19.
Background summary
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-triple state lifetime technique to
measure mitochondrial oxygenation tension (mitoPO2) in vivo, which possibly is
an early indicator of oxygen disbalance in the cell and therefore a
physiological trigger for fluid therapy.
Study objective
1. To describe mitoPO2 in clinically admitted critically ill septic patients
receiving fluid therapy (consisting of crystalloid, albumin and/or red cell
transfusion).
2. To describe the effects of fluid therapy on mitoPO2 and on other
physiological measures of tissue oxygenation and oxygen balance
3. To describe the association between (change of )mitoPO2 and vital organ
(dis)functions separately, and 24 hours SOFA score
4. To describe the association between mitoPO2 change and clinical outcomes,
like length of stay (both ICU and in-hospital) and mortality (both ICU and
in-hospital)
5. To describe the association between mitoPO2 and severity of sepsis to immune
parameters such as plasma cytokines and cellular phenotypes.
6. To describe the level of hypoxia, including mitoPO2, in critically ill
patients with sepsis due to COVID-19.
Study design
Prospective multi-center cohort study
Study burden and risks
The risks are minimal in this study with no serious adverse events known. The
burden for the septic patients is minimal since it*s a non-invasive
measurement. The normal clinical practice will continue and will not be
altered.
Albinusdreef 2
Leiden 2333 ZA
NL
Albinusdreef 2
Leiden 2333 ZA
NL
Listed location countries
Age
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
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT03842722 |
| CCMO | NL64824.058.18 |