SepsisINOX-SEPSISNCT03842722
Insufficient Oxygenation in Septic Patients
An observational study of Sepsis and Critical Care, run by Sanquin-LUMC J.J van Rood Center for Clinical Transfusion Research at 1 site in Netherlands.
Trial summary
This study will describe the change of mitochondrial oxygen tension (mitoPO2) compared to traditional parameters of oxygenation and oxygen balance in the first 24 hours of septic patients admitted to the intensive care unit of an academic hospital. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Critical Care, Mitochondria
- What is being tested?
- Protoporphyrin IX - Triplet State Lifetime Technique
- Type of treatment
- Medical device
- How many people
- 81 participants
- Where
- 1 siteNetherlands
- Study dates
- 13 Feb 2019to 28 Sep 2023
- 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: Patients in the emergency department or hospital ward admitted to the Intensive Care Unit of the Leiden University Medical Center with (the suspicion of) sepsis will be the source population of the study. Leiden Univesity Medical Center is an academic hospital. Septic patients are identified as specified in the Dutch protocol of sepsis identification and management in the emergency department. It consists of having clinical suspicion of sepsis in combination with the at least 2 of the following symptoms: ≥ 20 breaths per minute, heart frequency > 90 beats per minute, leukocytes > 12x109 or leukocytes < 4x10^9, and/or temperature > 38 °C or <36 °C
Who may be able to join
- Age of patient is at least 18 years
- Patients diagnosed with sepsis in the emergency department or hospital ward
- Patients are admitted to the ICU via the hospital ward or emergency department
- Informed consent is given either by the patient or if the patient is too ill to give informed consent, by his or her legal representative.
- Patients have an arterial catheter in situ, since blood samples will be taken for the study. Most patients admitted to the ICU have an arterial catheter in place since it is part of standard care.
Who cannot join
- Patients younger than 18 years
- Patients with sepsis discharged after emergency department visit
- Patients admitted to a hospital ward other than the ICU after emergency department visit
- Patients who cannot give informed consent themselves and without a legal representative will be excluded since no informed consent can be obtained
- Patients known with porphyria and/or photodermatosis will be excluded, since the risk of phototoxicity
- Patients with hypersensitivity to the active substance or to the plaster material of ALA (5-aminolevulinic acid)
- Pregnant or breast feeding women since there is no adequate data form the use of ALA in pregnant or breast feeding women
- Insufficient comprehensibility of the Dutch language
Trial locations and contacts
1 site in 1 country.
About this study
This study will describe the change of mitochondrial oxygen tension (mitoPO2) compared to traditional parameters of oxygenation and oxygen balance in the first 24 hours of septic patients admitted to the intensive care unit of an academic hospital. The mitoPO2 will be measured on prespecified measurement moments in the ICU. With each measurement moment, arterial and central venous blood gasses will be taken too.
Read the detailed description
Evidence is increasing that there is no clear parameter for tissue oxygenation in critically ill septic patients to guide resuscitation. 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 disbalance in the cell and therefore a physiological trigger for fluid therapy.
Objectives: 1. To describe mitoPO2 measurements in patients with sepsis who are about to receive fluid therapy 2. To describe the effects of fluid therapy and the associated change in mitoPO2 and change in other physiologic measures of tissue oxygenation and oxygen balance 3.To describe the association between mitoPO2 and vital organ (dis)functions and change of SOFA (Sequential organ failure assessment) score after 24hrs 5. To describe the microcirculatory, cellular and mitochondrial function during the first 24 hours of septic patients.
Study population: critically ill patients with sepsis which are admitted to the intensive care unit through the emergency department or hospital ward and in whom fluid therapy (crystalloid, albumin and red cell transfusion) is planned.
Main study endpoints
Primary endpoint: Change in mitoPO2 after fluid therapy. This will be compared to traditional parameters used to measure oxygenation and oxygen balance
Secondary endpoints:
- Association of mitoPO2 trend with separate (ischemic) organ (dis)function. The SOFA score after 24 hours will also be assessed.
- Safety of mitoPO2 measurements in critically ill septic patients.
- Description of the association of sepsis with microcirculatory function, cellular function and mitochondrial function.
- Description of the association between mitoPO2 change and clinical outcomes , like length of stay(both ICU and in-hospital) and mortality (both ICU and in-hospital).
- Conditions
- Sepsis, Critical Care, Mitochondria, Oxygen, Fluid Therapy
- Being tested
- Protoporphyrin IX - Triplet State Lifetime Technique
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protoporphyrin IX - Triplet State Lifetime TechniqueDevice
Protoporphyrin IX - Triplet State Lifetime Technique is a way to measure mitochondrial oxygen tension in a non-invasive way at bedside.
| Study group | Role | What they receive |
|---|---|---|
| Critically ill septic patients | Cohort: patients admitted via the emergency department or hospital ward to the intensive care unit of Leiden University Medical Center with the diagnosis sepsis or septic shock, who receive fluid therapy (either colloid, crystalloid and/or red blood cell) in their first day of admission to the ICU. Receives: Device: Protoporphyrin IX - Triplet State Lifetime Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of mitoPO2 during first 24 hours of a septic patient
The primary endpoint is the change of mitoPO2(mitochondrial oxygenation) before and after fluid therapy in patients with sepsis. This will be compared to traditional parameters used to measure tissue oxygenation and oxygen balance (central venous oxygen saturation, mean arterial pressure and lactate).
Measured: 24 hours
Secondary outcomes (8)
SOFA (sequential organ failure assessment) score after 24 hours
The association of mitoPO2 change in 24 hours with the Sequential Organ Failure Assessment score after 24 hours will be assessed. With the help of this information, more insight can be given in how much information the cutaneous mitoPO2 measurement gives about the organs separately and together.
Measured: 24 hours
Organ (dis)function
To describe the association between mitoPO2 change and separate organ functions.
Measured: 24 hours
Validation of mitoPO2 measurement with blood based biomarkers of cellular function
Cellular function will be assessed with blood-based biomarkers mitochondrial membrane potential (MMP), presence of cellular reactive oxygen species (ROS) molecules and glutathione (GSH) activity. Mitochondrial function will be assessed with mitoPO2 measurements.
Measured: 24 hours
Safety (incidence of adverse and serious adverse events)
The adverse and serious adverse events of the mitoPO2 measurements will be assessed.
Measured: 24 hours
Length of ICU stay
Association of mitoPO2 change and length of intensive care unit-stay.
Measured: 3 months
Length of hospital stay
Association of mitoPO2 change and length of hospital stay.
Measured: 3 months
ICU mortality
Association of mitoPO2 change and intensive care unit mortality.
Measured: 3 months
In-hospital mortality
Association of mitoPO2 change and in-hospital mortality.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start13 Feb 2019
- Primary completion28 Sep 2023
- Study completion28 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies 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
- 81 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
- Responsible party
- Principal investigator, J.G. van der Bom, Leiden University Medical Center
- Investigators
- Johanna G van der Bom, MD, PhD, Principal investigator, Leiden University Medical CenterM S Arbous, MD, PhD, Principal investigator, Leiden University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03842722
- Sponsor's protocol ID
- NL64824.058.18
- Acronym
- INOX-SEPSIS
- Status last verified
- May 2024
- First submitted
- 22 Oct 2018
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Insufficient Oxygenation in Septic Patients
- ClinicalTrials.gov ID
- NCT03842722
- Acronym / sponsor ID
- INOX-SEPSIS / NL64824.058.18
- Conditions
- Sepsis, Critical Care, Mitochondria, Oxygen, Fluid Therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Sanquin-LUMC J.J van Rood Center for Clinical Transfusion ResearchUniversity, hospital or other
- Collaborators
- Leiden University Medical Center
- Study start
- 13 Feb 2019 (actual)
- Primary completion
- 28 Sep 2023 (actual)
- Study completion
- 28 Sep 2023 (actual)
- First posted
- 15 Feb 2019 (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.
This study will describe the change of mitochondrial oxygen tension (mitoPO2) compared to traditional parameters of oxygenation and oxygen balance in the first 24 hours of septic patients admitted to the intensive care unit of an academic hospital. The mitoPO2 will be measured on prespecified measurement moments in the ICU. With each measurement moment, arterial and central venous blood gasses will be taken too.
Detailed description
Evidence is increasing that there is no clear parameter for tissue oxygenation in critically ill septic patients to guide resuscitation. 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 disbalance in the cell and therefore a physiological trigger for fluid therapy.
Objectives: 1. To describe mitoPO2 measurements in patients with sepsis who are about to receive fluid therapy 2. To describe the effects of fluid therapy and the associated change in mitoPO2 and change in other physiologic measures of tissue oxygenation and oxygen balance 3.To describe the association between mitoPO2 and vital organ (dis)functions and change of SOFA (Sequential organ failure assessment) score after 24hrs 5. To describe the microcirculatory, cellular and mitochondrial function during the first 24 hours of septic patients.
Study population: critically ill patients with sepsis which are admitted to the intensive care unit through the emergency department or hospital ward and in whom fluid therapy (crystalloid, albumin and red cell transfusion) is planned.
Main study endpoints
Primary endpoint: Change in mitoPO2 after fluid therapy. This will be compared to traditional parameters used to measure oxygenation and oxygen balance
Secondary endpoints:
- Association of mitoPO2 trend with separate (ischemic) organ (dis)function. The SOFA score after 24 hours will also be assessed.
- Safety of mitoPO2 measurements in critically ill septic patients.
- Description of the association of sepsis with microcirculatory function, cellular function and mitochondrial function.
- Description of the association between mitoPO2 change and clinical outcomes , like length of stay(both ICU and in-hospital) and mortality (both ICU and in-hospital).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Critically ill septic patients | – | Device: Protoporphyrin IX - Triplet State Lifetime TechniqueCohort: patients admitted via the emergency department or hospital ward to the intensive care unit of Leiden University Medical Center with the diagnosis sepsis or septic shock, who receive fluid therapy (either colloid, crystalloid and/or red blood cell) in their first day of admission to the ICU. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients in the emergency department or hospital ward admitted to the Intensive Care Unit of the Leiden University Medical Center with (the suspicion of) sepsis will be the source population of the study. Leiden Univesity Medical Center is an academic hospital. Septic patients are identified as specified in the Dutch protocol of sepsis identification and management in the emergency department. It consists of having clinical suspicion of sepsis in combination with the at least 2 of the following symptoms: ≥ 20 breaths per minute, heart frequency > 90 beats per minute, leukocytes > 12x109 or leukocytes < 4x10^9, and/or temperature > 38 °C or <36 °C
Key inclusion criteria (5 listed)
- Age of patient is at least 18 years
- Patients diagnosed with sepsis in the emergency department or hospital ward
- Patients are admitted to the ICU via the hospital ward or emergency department
- Informed consent is given either by the patient or if the patient is too ill to give informed consent, by his or her legal representative.
- Patients have an arterial catheter in situ, since blood samples will be taken for the study. Most patients admitted to the ICU have an arterial catheter in place since it is part of standard care.
Key exclusion criteria (8 listed)
- Patients younger than 18 years
- Patients with sepsis discharged after emergency department visit
- Patients admitted to a hospital ward other than the ICU after emergency department visit
- Patients who cannot give informed consent themselves and without a legal representative will be excluded since no informed consent can be obtained
- Patients known with porphyria and/or photodermatosis will be excluded, since the risk of phototoxicity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Protoporphyrin IX - Triplet State Lifetime TechniqueProtoporphyrin IX - Triplet State Lifetime Technique is a way to measure mitochondrial oxygen tension in a non-invasive way at bedside. | Device | Critically ill septic patients |
Primary outcome
Change of mitoPO2 during first 24 hours of a septic patient
Time frame: 24 hours
The primary endpoint is the change of mitoPO2(mitochondrial oxygenation) before and after fluid therapy in patients with sepsis. This will be compared to traditional parameters used to measure tissue oxygenation and oxygen balance (central venous oxygen saturation, mean arterial pressure and lactate).
8 secondary outcomes
SOFA (sequential organ failure assessment) score after 24 hours
Time frame: 24 hours
Organ (dis)function
Time frame: 24 hours
Validation of mitoPO2 measurement with blood based biomarkers of cellular function
Time frame: 24 hours
Safety (incidence of adverse and serious adverse events)
Time frame: 24 hours
Length of ICU stay
Time frame: 3 months
Length of hospital stay
Time frame: 3 months
ICU mortality
Time frame: 3 months
In-hospital mortality
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Individual participant dataSharing planned: No
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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, MD, PhD principal investigator
Leiden University Medical Center
M S Arbous, MD, PhD principal investigator
Leiden University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and Critical Care, run by Sanquin-LUMC J.J van Rood Center for Clinical Transfusion Research at 1 site 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 5 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: finished, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change of mitoPO2 during first 24 hours of a septic patient (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 May 2024.