1. To determine the feasibility and variability of mitoPO2 measurement in critically ill intensive care unit (ICU) patients who are about to receive a transfusion 2. To describe the effects of red cell transfusion and the associated change in [Hb]…
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Source
Brief title
Condition
- Other condition
Synonym
Health condition
anemie bij kritisch zieke mensen op de IC
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is the variability of mitoPO2 before and after red cell
transfusion. This will be compared to traditional parameters used to measure
oxygenation and oxygen balance(ScvO2, SaO2, PaO2, PvO2, CI, lactate). Another
primary endpoint is the value of mitoPO2 measurements for predicting (ischemic)
organ damage. The following parameters for organ damage (that are routinely
collected ) will be assessed: lung (pO2/FiO2 ratio), heart (troponin, CK, an
ECG, CI), renal (creatinine, urine production, glomerular filtration rate,
RIFLE classification), brain (delirium, RASS) and SOFA score.
Secondary outcome
Secondary study parameters include:
- Length of ICU stay
- Length of stay in hospital
- Hospital mortality
- ICU mortality
- 90 day mortality
- Adverse and serious adverse events of the mitoPO2 measurements
- Need for mechanical ventilation
- Need for renal replacements therapy
- Microcirculatory value of mitoPO2
- Possible bias of mitoPO2 measurements (skin temperature, vasopressor use,
inotropic therapy)
Background summary
Depending on the duration of critical illness eventually all critically ill
patients develop anaemia which may severely affect their recuperation.
Deleterious effects of severe anaemia include a generalized decrease in oxygen
carrying capacity and ensuing multi-organ failure. The notion that critically
ill patients with [Hb] above 7 or 8 g/dl, might not profit from red cell
transfusions has been confirmed by many other studies and is now widely adopted
in clinical guidelines. Yet, there is also increasing evidence that in some
cases a [Hb] transfusion trigger of 7- 8 g/dl may be too low. Whether these
findings are solid enough to change clinical practice is heavily debated. These
uncertainties about efficacy and safety of transfusion lead to undesirable
ambiguities in ICU transfusion practice.
Dr. Bert Mik has recently introduced the protoporphyrin IX-triplet state
lifetime technique as the first method to measure mitochondrial oxygen tension
(mitoPO2) in living cells and tissues. The mitoPO2 measurement was able to
predict the need for a red cell transfusion in animal models and in healty
volunteers. However, the predictibility of transfusion of critical ill patients
hasn't been studied yet. We hypothesize that mitoPO2 can be used as an early
indicator of organ dysfunction as well. If this is true, mitoPO2 can possibly
be used to administer or postpone red cell transfusion in patients with
anaemia.
Study objective
1. To determine the feasibility and variability of mitoPO2 measurement in
critically ill intensive care unit (ICU) patients who are about to receive a
transfusion 2. To describe the effects of red cell transfusion and the
associated change in [Hb] on mitoPO2 and on other physiologic measures of
tissue oxygenation and oxygen balance 3.To describe the association between
mitoPO2 and vital organ functions
Study design
Prospective multicenter cohort study
Study burden and risks
The risks are neglible in this study with no SAE known. The burden for the
ICU-patients is minimal since it*s a non-invasive measurement. The normal
clinical practice will continue and will not be altered with. Since most
ICU-patients are in the most controlled environment with a central venous
catheter and arterial catheter in situ, they are the most ideal patient to
investigate mitoPO2 feasibility, accuracy and associations with other
physiological parameters.
This is the very first research on mitoPO2*s clinical applicability in
critically ill patients with anaemia and the first attempt to personalize blood
transfusion decisions in the ICU based on individual assessment of the ability
of oxygen transport to tissue to fulfill actual oxygen utilization. We
hypothesize that mitoPO2 can be used as an early indicator of organ dysfunction
as well. If this is true, mitoPO2 can possibly be used to administer or
postpone red cell transfusion in patients with anaemia.
Albinusdreef 2 Albinusdreef 2
Leiden 2333 ZA
NL
Albinusdreef 2 Albinusdreef 2
Leiden 2333 ZA
NL
Listed location countries
Age
Inclusion criteria
During the pilot study: all adult patients, admitted to the intensive care unit
with [Hb] below 6,3 mmol/l, who are planned to undergo a transfusion of red
blood cells.
During the prospective cohort study: all patients with a Hb below 6.3 mmol/l in
whom an arterial catheter is in place and in whom a red cell transfusion is
planned.
Exclusion criteria
-adults without an legal representative for the informed consent,
-less than 18 years old,
-patients in need of emergency red cell transfusion e.g. bleeding,
-porphyria,
-known photodermatosis,
-ICU stay <24hrs,
-pregnant or breast feeding women since there is no adequate data from the use
of ALA in pregnant or breast feeding women,
-hypersensitivity to the active substance or to the plaster material of ALA,
-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
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 | NCT03092297 |
| CCMO | NL59512.058.16 |