Insufficient Cellular Oxygen in ICU Patients With Anaemia (INOX ICU-2)
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|ClinicalTrials.gov Identifier: NCT03092297|
Recruitment Status : Recruiting
First Posted : March 27, 2017
Last Update Posted : March 23, 2021
|Condition or disease|
|Critical Care Anemia Erythrocyte Transfusion Oxygen Mitochondria|
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.
|Study Type :||Observational|
|Estimated Enrollment :||240 participants|
|Official Title:||Insufficient Cellular Oxygen in ICU Patients With Anaemia: the INOX ICU-2 Study|
|Actual Study Start Date :||May 16, 2017|
|Estimated Primary Completion Date :||July 1, 2021|
|Estimated Study Completion Date :||December 1, 2021|
ICU patients with anaemia
At admission to the ICU all patients, or their legal representatives, expected to stay at the ICU for longer than 24 hours will be asked to participate in the study and will be asked informed consent. ICU patients with anaemia in whom a central venous catheter is already in place and in whom a red cell transfusion is planned, will be included in the study.
- Variability of mitoPO2 [ Time Frame: Variability of mitoPO2 will be assessed during 8 predefined moments (within a timeframe of 24 hours) in the study ]Variability of mitoPO2 before and after red cell transfusion. This will be compared to traditional parameters used to measure oxygenation and oxygen balance.
- Organ damage [ Time Frame: Value of mitoPO2 in predicting (ischemic) organ damage will be assessed during 8 predefined moments (within a timeframe of 24 hours) in the study ]Value of mitoPO2 measurements for predicting (ischemic) organ damage
- Microcirculation [ Time Frame: Association of the mitoPO2 with the microcirculation will be assessed during 2 predefined moments (before transfusion and 24 hours after transfusion) in the study ]Association of mitoPO2 with the microcirculation
- Length of stay [ Time Frame: Length of stay will be assessed during the 3 months follow-up time ]Length of hospital-stay and ICu stay
- Mortality [ Time Frame: Mortality will be assessed during the 3 months follow-up time ]90-day mortality, hospital mortality and ICU mortality
- Adverse events [ Time Frame: Association of the mitoPO2 with adverse events will be assessed during 8 predefined moments (within a timeframe of 24 hours) in the study ]Adverse and serious adverse events of the mitoPO2 measurements
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03092297
|Contact: Meryem Baysan, MD||+31715297274||M.Baysan@lumc.nl|
|Contact: Johanna G van der Bom, PhD, MD||+310715268871||J.G.van_der_Bom@lumc.nl|
|Amsterdam Medical Center||Completed|
|Amsterdam, Amsterdam-Zuidoost, Noord-Holland, Netherlands, 1105 AZ|
|Leiden University Medical Center||Recruiting|
|Leiden, Zuid-Holland, Netherlands, 2333 ZA|
|Contact: M S Arbous, PhD, MD ++31715261678 M.S.Arbous@lumc.nl|
|Contact: J G van der Bom, PhD, MD +31715268871 J.G.van_der_Bom@lumc.nl|
|Principal Investigator: M Baysan, MD|
|Erasmus University Medical Center||Withdrawn|
|Rotterdam, Zuid-Holland, Netherlands, 3015 CE|
|Study Chair:||Johanna G van der Bom, PhD, MD||Leiden University Medical Center and Sanquin Research Leiden|
|Study Chair:||M S Arbous, PhD, MD||Leiden University Medical Center|
|Principal Investigator:||M Baysan, MD||Leiden University Medical Center and Sanquin Research Leiden|