Clinical trial NCT03092297: Insufficient Cellular Oxygen in ICU Patients With Anaemia
Official title: Insufficient Cellular Oxygen in ICU Patients With Anaemia: the INOX ICU-2 Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Critical Care
Anemia
Erythrocyte Transfusion
Oxygen
Mitochondria
Lead sponsor: Sanquin-LUMC J.J van Rood Center for Clinical Transfusion Research
Sponsor class: OTHER
Collaborators: name: Leiden University Medical Center
name: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: Erasmus Medical Center
First posted: 2017-03-27
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All adult patients admitted to the intensive care unit with a Hb below 6.3 mmol/l, with a central venous catheter in situ, who are planned to undergo a transfusion of red blood cells

Brief summary: The purpose of this study is whether the mitochondrial oxygenation tension (mitoPO2) is a feasible and reliable tool in ICU patients with anaemia undergoing red cell transfusion to ultimately personalize blood transfusion decisions in the ICU.

Detailed description: Evidence is increasing that in some cases a Hb trigger of 7-8g/dl may be too low and te question arises whether an individualized red cell transfusion strategy may benefit critically ill patients. 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 disturbance in the cell and therefore a physiological trigger for red cell transfusion. The goals are: 1. Determining the feasibility of using mitoPO2 and the variability of mitoPO2 measurements in critically ill intensive care unit (ICU) patients before and after receiving a red cell transfusion 2. Describing 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. Describing the association between mitoPO2 and vital organ functions. Included patients will undergo red cell transfusion as planned. However, red cell transfusion will be delayed by 2 hours. At multiple predefined moments data collection including blood samples and measurements of mitoPO2 will take place.

The results of this study cannot be immediately translated to clinical practice. Using these results, the investigators will design a phase 2 diagnostic study, most probably a randomized clinical trial that will yield applied knowledge with respect to personalizing red cell transfusion. Application will be in ICU patients with anaemia who might or might not profit from red cell transfusions. It will lead to a reduction of both over- and under- transfusion.

Eligibility criteria: Inclusion Criteria:

* adult patient admitted to the ICU
* Hb below 6.3 mmol/l (10 g/dl)
* central venous catheter in situ
* red cell transfusion planned

Exclusion Criteria:

* adults without a legal representative to ask for informed consent
* patients less than 18 years old
* pregnant or breast feeding women
* patients in need of emergency red cell transfusion e.g. bleeding
* not having a central venous catheter in situ
* porphyria and or known photodermatosis
* patients with an expected ICU stay \<24 hours
* patients with hypersensitivity to the active substance or to the plaster material of ALA

Primary outcomes:
measure: Variability of mitoPO2
timeFrame: Variability of mitoPO2 will be assessed during 8 predefined moments (within a timeframe of 24 hours) in the study
Secondary outcomes:
measure: Organ damage
timeFrame: Value of mitoPO2 in predicting (ischemic) organ damage will be assessed during 8 predefined moments (within a timeframe of 24 hours) in the study
measure: Microcirculation
timeFrame: Association of the mitoPO2 with the microcirculation will be assessed during 2 predefined moments (before transfusion and 24 hours after transfusion) in the study
measure: Length of stay
timeFrame: Length of stay will be assessed during the 3 months follow-up time
measure: Mortality
timeFrame: Mortality will be assessed during the 3 months follow-up time
measure: Adverse events
timeFrame: Association of the mitoPO2 with adverse events will be assessed during 8 predefined moments (within a timeframe of 24 hours) in the study
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Amsterdam Medical Center
state: Amsterdam-Zuidoost, Noord-Holland
city: Leiden
country: Netherlands
facility: Leiden University Medical Center
state: Zuid-Holland
Study officials:
affiliation: Leiden University Medical Center and Sanquin Research Leiden
name: Johanna G van der Bom, PhD, MD
role: STUDY_CHAIR
affiliation: Leiden University Medical Center
name: M S Arbous, PhD, MD
role: STUDY_CHAIR
affiliation: Leiden University Medical Center and Sanquin Research Leiden
name: M Baysan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Baysan M, Arbous MS, Mik EG, Juffermans NP, van der Bom JG. Study protocol and pilot results of an observational cohort study evaluating effect of red blood cell transfusion on oxygenation and mitochondrial oxygen tension in critically ill patients with anaemia: the INsufficient Oxygenation in the Intensive Care Unit (INOX ICU-2) study. BMJ Open. 2020 May 17;10(5):e036351. doi: 10.1136/bmjopen-2019-036351.