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Insufficient Cellular Oxygen in ICU Patients With Anaemia

Insufficient Cellular Oxygen in ICU Patients With Anaemia: the INOX ICU-2 Study

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03092297
Acronym
INOX ICU-2
Enrollment
103
Registered
2017-03-27
Start date
2017-05-16
Completion date
2022-12-01
Last updated
2023-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia, Critical Care, Erythrocyte Transfusion, Mitochondria, Oxygen

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.

Interventions

None listed

Sponsors

Leiden University Medical Center
CollaboratorOTHER
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
CollaboratorOTHER
Erasmus Medical Center
CollaboratorOTHER
Sanquin-LUMC J.J van Rood Center for Clinical Transfusion Research
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Variability of mitoPO2Variability of mitoPO2 will be assessed during 8 predefined moments (within a timeframe of 24 hours) in the studyVariability of mitoPO2 before and after red cell transfusion. This will be compared to traditional parameters used to measure oxygenation and oxygen balance.

Secondary

MeasureTime frameDescription
Organ damageValue of mitoPO2 in predicting (ischemic) organ damage will be assessed during 8 predefined moments (within a timeframe of 24 hours) in the studyValue of mitoPO2 measurements for predicting (ischemic) organ damage
MicrocirculationAssociation of the mitoPO2 with the microcirculation will be assessed during 2 predefined moments (before transfusion and 24 hours after transfusion) in the studyAssociation of mitoPO2 with the microcirculation
Length of stayLength of stay will be assessed during the 3 months follow-up timeLength of hospital-stay and ICu stay
MortalityMortality will be assessed during the 3 months follow-up time90-day mortality, hospital mortality and ICU mortality
Adverse eventsAssociation of the mitoPO2 with adverse events will be assessed during 8 predefined moments (within a timeframe of 24 hours) in the studyAdverse and serious adverse events of the mitoPO2 measurements

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026