Critical CareINOX ICU-2NCT03092297
Insufficient Cellular Oxygen in ICU Patients With Anaemia
An observational study of Critical Care and Anemia, run by Sanquin-LUMC J.J van Rood Center for Clinical Transfusion Research at 2 sites in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Care, Anemia, Erythrocyte Transfusion
- How many people
- 103 participants
- Where
- 2 sitesNetherlands
- Study dates
- 16 May 2017to 1 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- adult patient admitted to the ICU
- Hb below 6.3 mmol/l (10 g/dl)
- central venous catheter in situ
- red cell transfusion planned
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
Amsterdam Medical Center
Amsterdam, Amsterdam-Zuidoost, Noord-Holland, 1105 AZ
Leiden University Medical Center
Leiden, South Holland, 2333 ZA
About this study
Official title: Insufficient Cellular Oxygen in ICU Patients With Anaemia: the INOX ICU-2 Study
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.
Read the 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.
- Conditions
- Critical Care, Anemia, Erythrocyte Transfusion, Oxygen, Mitochondria
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Variability of mitoPO2 will be assessed during 8 predefined moments (within a timeframe of 24 hours) in the study
Secondary outcomes (5)
Organ damage
Value of mitoPO2 measurements for predicting (ischemic) organ damage
Measured: Value of mitoPO2 in predicting (ischemic) organ damage will be assessed during 8 predefined moments (within a timeframe of 24 hours) in the study
Microcirculation
Association of mitoPO2 with the microcirculation
Measured: Association of the mitoPO2 with the microcirculation will be assessed during 2 predefined moments (before transfusion and 24 hours after transfusion) in the study
Length of stay
Length of hospital-stay and ICu stay
Measured: Length of stay will be assessed during the 3 months follow-up time
Mortality
90-day mortality, hospital mortality and ICU mortality
Measured: Mortality will be assessed during the 3 months follow-up time
Adverse events
Adverse and serious adverse events of the mitoPO2 measurements
Measured: Association of the mitoPO2 with adverse events will be assessed during 8 predefined moments (within a timeframe of 24 hours) in the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2017
- Study start16 May 2017
- Primary completion1 Jul 2021
- Study completion1 Dec 2022
Why it stopped: COVID-19 pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Critical CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanquin-LUMC J.J van Rood Center for Clinical Transfusion Research
- Sponsor type
- University, hospital or other
- Collaborators
- Leiden University Medical Center, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Erasmus Medical Center
- Responsible party
- Sponsor
- Investigators
- Johanna G van der Bom, PhD, MD, Study chair, Leiden University Medical Center and Sanquin Research LeidenM S Arbous, PhD, MD, Study chair, Leiden University Medical CenterM Baysan, MD, Principal investigator, Leiden University Medical Center and Sanquin Research Leiden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03092297
- Sponsor's protocol ID
- NL59512.058.16
- Acronym
- INOX ICU-2
- Status last verified
- Dec 2022
- First submitted
- 13 Mar 2017
- Last updated
- 19 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided: to be decided
Publications
Baysan M, Hilderink B, van Manen L, Caram-Deelder C, Mik EG, Juffermans NP, van der Bom JG, Arbous MS. Mitochondrial oxygen tension in critically ill patients receiving red blood cell transfusions: a multicenter observational cohort study. Intensive Care Med Exp. 2024 Jul 8;12(1):61. doi: 10.1186/s40635-024-00646-3.
PubMed 38976096Baysan 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.
PubMed 32423938
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Insufficient Cellular Oxygen in ICU Patients With Anaemia: the INOX ICU-2 Study
- ClinicalTrials.gov ID
- NCT03092297
- Acronym / sponsor ID
- INOX ICU-2 / NL59512.058.16
- Conditions
- Critical Care, Anemia, Erythrocyte Transfusion, Oxygen, Mitochondria
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: COVID-19 pandemic
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Sanquin-LUMC J.J van Rood Center for Clinical Transfusion ResearchUniversity, hospital or other
- Collaborators
- Leiden University Medical Center, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Erasmus Medical Center
- Study start
- 16 May 2017 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 27 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- adult patient admitted to the ICU
- Hb below 6.3 mmol/l (10 g/dl)
- central venous catheter in situ
- red cell transfusion planned
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
5 secondary outcomes
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
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
Length of stay
Time frame: Length of stay will be assessed during the 3 months follow-up time
Mortality
Time frame: Mortality will be assessed during the 3 months follow-up time
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
Results and safety
The study was stopped early (reason given: COVID-19 pandemic). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2023.
- Derived from this study: PubMed 38976096Baysan M, Hilderink B, van Manen L, Caram-Deelder C, Mik EG, Juffermans NP, van der Bom JG, Arbous MS. Mitochondrial oxygen tension in critically ill patients receiving red blood cell transfusions: a multicenter observational cohort study. Intensive Care Med Exp. 2024 Jul 8;12(1):61. doi: 10.1186/s40635-024-00646-3.
- Derived from this study: PubMed 32423938Baysan 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.
- Individual participant dataSharing planned: Undecided. to be decided
Related trials for Critical Care
Enrolling by invitationObservational study
WSACS 2026 Delphi Consensus on the Practical Management of Intra-abdominal Hypertension and Abdominal Compartment Syndrome
Intra-Abdominal Hypertension, Abdominal Compartment Syndrome
Not yet recruitingPhase 4
Ceftriaxone Dosage for Non-Critical Community-Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 3
Canadian Critical Care Comparative Effectiveness Platform
Intensive Care Unit ICU, Vasopressor
Active, not recruiting
Weighted Blankets for Agitation in Adults in the Intensive Care Unit
Psychomotor Agitation, Critical Illness
Not yet recruitingObservational study
Core Competencies in General Intensive Care Ultrasound (GenIUS): a Delphi Study
Critical Illness, Ultrasound
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johanna G van der Bom, PhD, MD study chair
Leiden University Medical Center and Sanquin Research Leiden
M S Arbous, PhD, MD study chair
Leiden University Medical Center
M Baysan, MD principal investigator
Leiden University Medical Center and Sanquin Research Leiden
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Care and Anemia, run by Sanquin-LUMC J.J van Rood Center for Clinical Transfusion Research at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: COVID-19 pandemic). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variability of mitoPO2 (time frame: Variability of mitoPO2 will be assessed during 8 predefined moments (within a timeframe of 24 hours) in the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03092297, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2023.