Insufficient Cellular Oxygen in ICU Patients With Anaemia

Anemia Clinical Trial

— INOX ICU-2  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03092297
• Other study ID #: NL59512.058.16
• Status: Terminated
• Start date: May 16, 2017
• Est. completion date: December 1, 2022

Study information

• Verified date: December 2022
• Source: Sanquin-LUMC J.J van Rood Center for Clinical Transfusion Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 103
• Est. completion date: December 1, 2022
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anemia
• Critical Care
• Erythrocyte Transfusion
• Mitochondria
• Oxygen

Locations

Country	Name	City	State
Netherlands	Amsterdam Medical Center	Amsterdam	Amsterdam-Zuidoost, Noord-Holland
Netherlands	Leiden University Medical Center	Leiden	Zuid-Holland

Sponsors (4)

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

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Variability of mitoPO2	Variability of mitoPO2 before and after red cell transfusion. This will be compared to traditional parameters used to measure oxygenation and oxygen balance.	Variability of mitoPO2 will be assessed during 8 predefined moments (within a timeframe of 24 hours) in the study
Secondary	Organ damage	Value of mitoPO2 measurements for predicting (ischemic) organ damage	Value of mitoPO2 in predicting (ischemic) organ damage will be assessed during 8 predefined moments (within a timeframe of 24 hours) in the study
Secondary	Microcirculation	Association of mitoPO2 with the microcirculation	Association of the mitoPO2 with the microcirculation will be assessed during 2 predefined moments (before transfusion and 24 hours after transfusion) in the study
Secondary	Length of stay	Length of hospital-stay and ICu stay	Length of stay will be assessed during the 3 months follow-up time
Secondary	Mortality	90-day mortality, hospital mortality and ICU mortality	Mortality will be assessed during the 3 months follow-up time
Secondary	Adverse events	Adverse and serious adverse events of the mitoPO2 measurements	Association of the mitoPO2 with adverse events will be assessed during 8 predefined moments (within a timeframe of 24 hours) in the study