DeliriumNCT04575753
Evaluating the Role of Pre-existing Resolvins in the Resolution of ICU Delirium
An observational study of Delirium, run by Université Libre de Bruxelles at 1 site in Belgium.
Trial summary
As patient management is improving, more and more ICU survivors are being confronted with cognitive dysfunction and this well after their hospital stay. In the ICU, delirium rates have been reported to be as high at 81%. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Delirium
- What is being tested?
- Study group
- How many people
- 0 participants
- Where
- 1 siteBelgium
- Study dates
- 7 Oct 2023to 30 Jun 2024
- 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: Non-ventilated, non-sedated adult patients of all genders with a planned ICU stay >72 hours at the CHU de Charleroi, Charleroi, Belgium between October 2020- May 2021 will be included in this study.
Who may be able to join
- Non-ventilated, non-sedated adult patients with a planned ICU stay >72 hours. - - patients admitted due to an exacerbation of COPD
- patients admitted due to severe trauma
- patients admitted due to cardiogenic shock
- patients admitted due to septic shock
Who cannot join
- Patients who don't understand English, French or Dutch
- Patients who are visually/auditory impaired (without glasses/ hearing aid)
- Patients with known neuro-psychiatric disorders
- Patients with known recreational drug and alcohol (ab)use
- Patients with a neurological trauma
- Patients on ECMO
Trial locations and contacts
1 site in 1 country.
About this study
As patient management is improving, more and more ICU survivors are being confronted with cognitive dysfunction and this well after their hospital stay.
In the ICU, delirium rates have been reported to be as high at 81%. Delirium is associated with patient and family stress, increased hospital costs, increased duration of stay, escalation of care and increased mortality and morbidity.
Read more
The physiopathology of ICU cognitive impairment is complex and involves an inflammatory cascade Recently, the role of 'resolvins' derived from omega-3 fatty acids has been studied in the resolution of inflammation.
Therefore, this hypothesis of this study is that ICU patients with higher serum levels of resolvins at ICU admission, ICU day 2 and day 5 will have a lesser degree of cognitive impairment on day 5 of ICU stay.
Read the detailed description
As patient management is improving, more and more ICU survivors are being confronted with cognitive dysfunction and this well after their hospital stay.
Delirium is characterized by an acute onset or fluctuating course, inattention and either disorganized thought (manifesting as memory, language and orientation difficulties) or altered level of consciousness. Multiple forms exist: hyperactive versus hypoactive versus mixed.
In the ICU, delirium rates have been reported to be as high at 81%. Delirium is associated with patient and family stress, increased hospital costs, increased duration of stay, escalation of care and increased mortality and morbidity.
The physiopathology of ICU cognitive impairment is complex. One theory is that, during infection/trauma, the alarmin high molecular group box 1 (HMGB1) is released into the bloodstream by activated platelets.
This damage-associated molecular pattern (DAMP) can bind to pattern recognition receptors on circulating bone marrow-derived monocytes (BM-DMs), causing a platelet-monocyte interaction but also triggering the nuclear translocation of the transcription factor NF-kappaB which activates gene expression and release of pro-inflammatory cytokines. The onset of this inflammatory state disrupts the blood brain barrier.
Within the brain parenchyma the chemokine MCP-1 and, by signaling through its receptor, CCR2, attracts the BM-DMs. The influx of BM-DMs activates the resident quiescent microglia. Together, BM-DMs and activated microglia release HMGB1, IL-6, and IL-1β ; thereby disrupting long-term potentiation and the synaptic plasticity involved in cognitive functions of learning and memory.
Inability to successfully resolve the inflammatory cascade promotes the development of cognitive impairment.
Recently, the role of 'resolvins' derived from omega-3 fatty acids has been studied in the resolution of inflammation.
In a mouse model of perioperative neurocognitive disorder, maresin 1 (a metabolite of omega-3) improved post-operative cognition and prevented surgery-induced glial activation and opening of the blood brain barrier. Similarly, in the same model, aspirine-triggered resolving D1 improved post-operative cognition, reduced systemic IL-6 levels and reserved surgery-induced astrogliosis.
Mechanically ventilated ICU patients who benefitted from omega-3 supplements, had a lesser degree of ICU delirium.
Therefore, the hypothesis of this study is that ICU patients with higher serum levels of resolvins at ICU admission, ICU day 2 and day 5 will have a lesser degree of cognitive impairment on day 5 of ICU stay.
- Conditions
- Delirium
- Being tested
- Study group
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Study groupOther
Blood samples will be taken from ICU patients on the day of ICU admission, day 2 and day 5 after ICU admission.
Similarly, patients will be subjected to cognitive testing (CAM-ICU) to determine the presence of delirium
What is being measured
The primary outcome is the main question the study is designed to answer.
The influence of serum levels of resolvins (RvD1) at ICU admission, and ICU day 2 and day 5 on cognitive impairment (defined by CAM-ICU) on day 5 of ICU stay.
Blood samples will be drawn at the day of ICU admission, day 2 and day 5 after ICU admission to measure resolvins (RvD1; 17SHDHA; DHA) through mass spectrometry.
At the same timepoints, cognitive testing will be performed (CAM-ICU) to determine the presence or absence of delirium on day 5 of ICU admission.
Measured: 5 days
The influence of serum levels of resolvins (DHA) at ICU admission, and ICU day 2 and day 5 on cognitive impairment (defined by CAM-ICU) on day 5 of ICU stay.
Blood samples will be drawn at the day of ICU admission, day 2 and day 5 after ICU admission to measure resolvins (RvD1; 17SHDHA; DHA) through mass spectrometry.
At the same timepoints, cognitive testing will be performed (CAM-ICU) to determine the presence or absence of delirium on day 5 of ICU admission.
Measured: 5 days
The influence of serum levels of resolvins (17SHDHA)) at ICU admission, and ICU day 2 and day 5 on cognitive impairment (defined by CAM-ICU) on day 5 of ICU stay.
Blood samples will be drawn at the day of ICU admission, day 2 and day 5 after ICU admission to measure resolvins (RvD1; 17SHDHA; DHA) through mass spectrometry.
At the same timepoints, cognitive testing will be performed (CAM-ICU) to determine the presence or absence of delirium on day 5 of ICU admission.
Measured: 5 days
Secondary outcomes (25)
Inflammatory markers-delirium-day0
The influence of serum levels of CRP (at ICU admission) on cognitive impairment (defined by CAM-ICU) at ICU admission.
Measured: 1 day
Inflammatory markers-delirium-day0
The influence of serum levels of TNF-alpha (at ICU admission) on cognitive impairment (defined by CAM-ICU) at ICU admission.
Measured: 1 day
Inflammatory markers-delirium-day0
The influence of serum levels of HMGB1 (at ICU admission) on cognitive impairment (defined by CAM-ICU) at ICU admission.
Measured: 1 day
Inflammatory markers-delirium-day0
The influence of serum levels of PF4 (at ICU admission) on cognitive impairment (defined by CAM-ICU) at ICU admission.
Measured: 1 day
Inflammatory markers-delirium-day0
The influence of serum levels of lactate (at ICU admission) on cognitive impairment (defined by CAM-ICU) at ICU admission.
Measured: 1 day
Inflammatory markers-delirium-day2
The influence of serum levels of CRP (at ICU admission) on cognitive impairment (defined by CAM-ICU) on ICU day 2.
Measured: 2 days
Inflammatory markers-delirium-day2
The influence of serum levels of TNF-alpha (at ICU admission) on cognitive impairment (defined by CAM-ICU) on ICU day 2.
Measured: 2 days
Inflammatory markers-delirium-day2
The influence of serum levels of HMGB1 (at ICU admission) on cognitive impairment (defined by CAM-ICU) on ICU day 2.
Measured: 2 days
Inflammatory markers-delirium-day2
The influence of serum levels of PF4 (at ICU admission) on cognitive impairment (defined by CAM-ICU) on ICU day 2.
Measured: 2 days
Inflammatory markers-delirium-day2
The influence of serum levels of lactate (at ICU admission) on cognitive impairment (defined by CAM-ICU) on ICU day 2.
Measured: 2 days
Inflammatory markers-delirium-day5
The influence of serum levels of CRP (at ICU admission) on cognitive impairment (defined by CAM-ICU) on ICU day 5.
Measured: 5 days
Inflammatory markers-delirium-day5
The influence of serum levels of TNF-alpha (at ICU admission) on cognitive impairment (defined by CAM-ICU) on ICU day 5.
Measured: 5 days
Inflammatory markers-delirium-day5
The influence of serum levels of HMGB1 (at ICU admission) on cognitive impairment (defined by CAM-ICU) on ICU day 5.
Measured: 5 days
Inflammatory markers-delirium-day5
The influence of serum levels of PF4 (at ICU admission) on cognitive impairment (defined by CAM-ICU) on ICU day 5.
Measured: 5 days
Inflammatory markers-delirium-day5
The influence of serum levels of lactate (at ICU admission) on cognitive impairment (defined by CAM-ICU) on ICU day 5.
Measured: 5 days
Inflammatory markers2-delirium-2
The influence of serum levels of CRP (on day 2) on cognitive impairment (defined by CAM-ICU) on ICU day 2.
Measured: 2 days
Inflammatory markers2-delirium-2
The influence of serum levels of TNF-alpha (on day 2) on cognitive impairment (defined by CAM-ICU) on ICU day 2.
Measured: 2 days
Inflammatory markers2-delirium-2
The influence of serum levels of HMGB1 (on day 2) on cognitive impairment (defined by CAM-ICU) on ICU day 2.
Measured: 2 days
Inflammatory markers2-delirium-2
The influence of serum levels of lactate (on day 2) on cognitive impairment (defined by CAM-ICU) on ICU day 2.
Measured: 2 days
Inflammatory markers2-delirium-2
The influence of serum levels of PF4 (on day 2) on cognitive impairment (defined by CAM-ICU) on ICU day 2.
Measured: 2 days
Inflammatory markers2-delirium-5
The influence of serum levels of CRP (on day 2) on cognitive impairment (defined by CAM-ICU) on ICU day 5.
Measured: 5 days
Inflammatory markers5-delirium-5
The influence of serum levels of TNF-alpha (on day 5) on cognitive impairment (defined by CAM-ICU) on ICU day 5.
Measured: 5 days
Inflammatory markers5-delirium-5
The influence of serum levels of HMGB1 (on day 5) on cognitive impairment (defined by CAM-ICU) on ICU day 5.
Measured: 5 days
Inflammatory markers5-delirium-5
The influence of serum levels of PF4 (on day 5) on cognitive impairment (defined by CAM-ICU) on ICU day 5.
Measured: 5 days
Inflammatory markers5-delirium-5
The influence of serum levels of lactate (on day 5) on cognitive impairment (defined by CAM-ICU) on ICU day 5.
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2020
- Study start7 Oct 2023 (estimated)
- Primary completion30 May 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Why it stopped: COVID-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for DeliriumStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université Libre de Bruxelles
- Sponsor type
- University, hospital or other
- Collaborators
- CHU de Charleroi
- Responsible party
- Principal investigator, Sarah Saxena, Université Libre de Bruxelles
- Investigators
- Michael Piagnerelli, MD; PHD, Study chair, CHU de Charleroi, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04575753
- Sponsor's protocol ID
- Resolvin-delirium
- Status last verified
- Mar 2025
- First submitted
- 22 Sep 2020
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will be made available, anonymously, if needed
Publications
Ely EW, Margolin R, Francis J, May L, Truman B, Dittus R, Speroff T, Gautam S, Bernard GR, Inouye SK. Evaluation of delirium in critically ill patients: validation of the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU). Crit Care Med. 2001 Jul;29(7):1370-9. doi: 10.1097/00003246-200107000-00012.
PubMed 11445689Leslie DL, Inouye SK. The importance of delirium: economic and societal costs. J Am Geriatr Soc. 2011 Nov;59 Suppl 2(Suppl 2):S241-3. doi: 10.1111/j.1532-5415.2011.03671.x.
PubMed 22091567Rouhiainen A, Imai S, Rauvala H, Parkkinen J. Occurrence of amphoterin (HMG1) as an endogenous protein of human platelets that is exported to the cell surface upon platelet activation. Thromb Haemost. 2000 Dec;84(6):1087-94.
PubMed 11154118Vacas S, Degos V, Tracey KJ, Maze M. High-mobility group box 1 protein initiates postoperative cognitive decline by engaging bone marrow-derived macrophages. Anesthesiology. 2014 May;120(5):1160-7. doi: 10.1097/ALN.0000000000000045.
PubMed 24162463Hu J, Feng X, Valdearcos M, Lutrin D, Uchida Y, Koliwad SK, Maze M. Interleukin-6 is both necessary and sufficient to produce perioperative neurocognitive disorder in mice. Br J Anaesth. 2018 Mar;120(3):537-545. doi: 10.1016/j.bja.2017.11.096. Epub 2018 Feb 3.
PubMed 29452810Terrando N, Eriksson LI, Ryu JK, Yang T, Monaco C, Feldmann M, Jonsson Fagerlund M, Charo IF, Akassoglou K, Maze M. Resolving postoperative neuroinflammation and cognitive decline. Ann Neurol. 2011 Dec;70(6):986-995. doi: 10.1002/ana.22664.
PubMed 22190370Cibelli M, Fidalgo AR, Terrando N, Ma D, Monaco C, Feldmann M, Takata M, Lever IJ, Nanchahal J, Fanselow MS, Maze M. Role of interleukin-1beta in postoperative cognitive dysfunction. Ann Neurol. 2010 Sep;68(3):360-8. doi: 10.1002/ana.22082.
PubMed 20818791Feng X, Valdearcos M, Uchida Y, Lutrin D, Maze M, Koliwad SK. Microglia mediate postoperative hippocampal inflammation and cognitive decline in mice. JCI Insight. 2017 Apr 6;2(7):e91229. doi: 10.1172/jci.insight.91229.
PubMed 28405620Saxena S, Lai IK, Li R, Maze M. Neuroinflammation is a putative target for the prevention and treatment of perioperative neurocognitive disorders. Br Med Bull. 2019 Jun 19;130(1):125-135. doi: 10.1093/bmb/ldz010.
PubMed 31049563Ishihara T, Yoshida M, Arita M. Omega-3 fatty acid-derived mediators that control inflammation and tissue homeostasis. Int Immunol. 2019 Aug 23;31(9):559-567. doi: 10.1093/intimm/dxz001.
PubMed 30772915Yang T, Xu G, Newton PT, Chagin AS, Mkrtchian S, Carlstrom M, Zhang XM, Harris RA, Cooter M, Berger M, Maddipati KR, Akassoglou K, Terrando N. Maresin 1 attenuates neuroinflammation in a mouse model of perioperative neurocognitive disorders. Br J Anaesth. 2019 Mar;122(3):350-360. doi: 10.1016/j.bja.2018.10.062. Epub 2018 Dec 28.
PubMed 30770053Terrando N, Gomez-Galan M, Yang T, Carlstrom M, Gustavsson D, Harding RE, Lindskog M, Eriksson LI. Aspirin-triggered resolvin D1 prevents surgery-induced cognitive decline. FASEB J. 2013 Sep;27(9):3564-71. doi: 10.1096/fj.13-230276. Epub 2013 May 24.
PubMed 23709617Naghibi T, Shafigh N, Mazloomzadeh S. Role of omega-3 fatty acids in the prevention of delirium in mechanically ventilated patients. J Res Med Sci. 2020 Jan 20;25:10. doi: 10.4103/jrms.JRMS_567_18. eCollection 2020.
PubMed 32055250
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Role of Pre-existing Resolvins in the Resolution of ICU Delirium
- ClinicalTrials.gov ID
- NCT04575753
- Acronym / sponsor ID
- Resolvin-delirium
- Conditions
- Delirium
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: COVID-19
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Université Libre de BruxellesUniversity, hospital or other
- Collaborators
- CHU de Charleroi
- Study start
- 7 Oct 2023 (estimated)
- Primary completion
- 30 May 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 5 Oct 2020 (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.
As patient management is improving, more and more ICU survivors are being confronted with cognitive dysfunction and this well after their hospital stay.
In the ICU, delirium rates have been reported to be as high at 81%. Delirium is associated with patient and family stress, increased hospital costs, increased duration of stay, escalation of care and increased mortality and morbidity.
The physiopathology of ICU cognitive impairment is complex and involves an inflammatory cascade Recently, the role of 'resolvins' derived from omega-3 fatty acids has been studied in the resolution of inflammation.
Therefore, this hypothesis of this study is that ICU patients with higher serum levels of resolvins at ICU admission, ICU day 2 and day 5 will have a lesser degree of cognitive impairment on day 5 of ICU stay.
Detailed description
As patient management is improving, more and more ICU survivors are being confronted with cognitive dysfunction and this well after their hospital stay.
Delirium is characterized by an acute onset or fluctuating course, inattention and either disorganized thought (manifesting as memory, language and orientation difficulties) or altered level of consciousness. Multiple forms exist: hyperactive versus hypoactive versus mixed.
In the ICU, delirium rates have been reported to be as high at 81%. Delirium is associated with patient and family stress, increased hospital costs, increased duration of stay, escalation of care and increased mortality and morbidity.
The physiopathology of ICU cognitive impairment is complex. One theory is that, during infection/trauma, the alarmin high molecular group box 1 (HMGB1) is released into the bloodstream by activated platelets.
This damage-associated molecular pattern (DAMP) can bind to pattern recognition receptors on circulating bone marrow-derived monocytes (BM-DMs), causing a platelet-monocyte interaction but also triggering the nuclear translocation of the transcription factor NF-kappaB which activates gene expression and release of pro-inflammatory cytokines. The onset of this inflammatory state disrupts the blood brain barrier.
Within the brain parenchyma the chemokine MCP-1 and, by signaling through its receptor, CCR2, attracts the BM-DMs. The influx of BM-DMs activates the resident quiescent microglia. Together, BM-DMs and activated microglia release HMGB1, IL-6, and IL-1β ; thereby disrupting long-term potentiation and the synaptic plasticity involved in cognitive functions of learning and memory.
Inability to successfully resolve the inflammatory cascade promotes the development of cognitive impairment.
Recently, the role of 'resolvins' derived from omega-3 fatty acids has been studied in the resolution of inflammation.
In a mouse model of perioperative neurocognitive disorder, maresin 1 (a metabolite of omega-3) improved post-operative cognition and prevented surgery-induced glial activation and opening of the blood brain barrier. Similarly, in the same model, aspirine-triggered resolving D1 improved post-operative cognition, reduced systemic IL-6 levels and reserved surgery-induced astrogliosis.
Mechanically ventilated ICU patients who benefitted from omega-3 supplements, had a lesser degree of ICU delirium.
Therefore, the hypothesis of this study is that ICU patients with higher serum levels of resolvins at ICU admission, ICU day 2 and day 5 will have a lesser degree of cognitive impairment on day 5 of ICU stay.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Non-ventilated, non-sedated adult patients of all genders with a planned ICU stay >72 hours at the CHU de Charleroi, Charleroi, Belgium between October 2020- May 2021 will be included in this study.
Key inclusion criteria (4 listed)
- Non-ventilated, non-sedated adult patients with a planned ICU stay >72 hours. - - patients admitted due to an exacerbation of COPD
- patients admitted due to severe trauma
- patients admitted due to cardiogenic shock
- patients admitted due to septic shock
Key exclusion criteria (6 listed)
- Patients who don't understand English, French or Dutch
- Patients who are visually/auditory impaired (without glasses/ hearing aid)
- Patients with known neuro-psychiatric disorders
- Patients with known recreational drug and alcohol (ab)use
- Patients with a neurological trauma
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 |
|---|---|---|
| Study groupBlood samples will be taken from ICU patients on the day of ICU admission, day 2 and day 5 after ICU admission. Similarly, patients will be subjected to cognitive testing (CAM-ICU) to determine the presence of delirium | Other | – |
Primary outcome
The influence of serum levels of resolvins (RvD1) at ICU admission, and ICU day 2 and day 5 on cognitive impairment (defined by CAM-ICU) on day 5 of ICU stay.
Time frame: 5 days
Blood samples will be drawn at the day of ICU admission, day 2 and day 5 after ICU admission to measure resolvins (RvD1; 17SHDHA; DHA) through mass spectrometry. At the same timepoints, cognitive testing will be performed (CAM-ICU) to determine the presence or absence of delirium on day 5 of ICU admission.
The influence of serum levels of resolvins (DHA) at ICU admission, and ICU day 2 and day 5 on cognitive impairment (defined by CAM-ICU) on day 5 of ICU stay.
Time frame: 5 days
Blood samples will be drawn at the day of ICU admission, day 2 and day 5 after ICU admission to measure resolvins (RvD1; 17SHDHA; DHA) through mass spectrometry. At the same timepoints, cognitive testing will be performed (CAM-ICU) to determine the presence or absence of delirium on day 5 of ICU admission.
The influence of serum levels of resolvins (17SHDHA)) at ICU admission, and ICU day 2 and day 5 on cognitive impairment (defined by CAM-ICU) on day 5 of ICU stay.
Time frame: 5 days
Blood samples will be drawn at the day of ICU admission, day 2 and day 5 after ICU admission to measure resolvins (RvD1; 17SHDHA; DHA) through mass spectrometry. At the same timepoints, cognitive testing will be performed (CAM-ICU) to determine the presence or absence of delirium on day 5 of ICU admission.
25 secondary outcomes
Inflammatory markers-delirium-day0
Time frame: 1 day
Inflammatory markers-delirium-day0
Time frame: 1 day
Inflammatory markers-delirium-day0
Time frame: 1 day
Inflammatory markers-delirium-day0
Time frame: 1 day
Inflammatory markers-delirium-day0
Time frame: 1 day
Inflammatory markers-delirium-day2
Time frame: 2 days
Inflammatory markers-delirium-day2
Time frame: 2 days
Inflammatory markers-delirium-day2
Time frame: 2 days
Inflammatory markers-delirium-day2
Time frame: 2 days
Inflammatory markers-delirium-day2
Time frame: 2 days
Inflammatory markers-delirium-day5
Time frame: 5 days
Inflammatory markers-delirium-day5
Time frame: 5 days
Inflammatory markers-delirium-day5
Time frame: 5 days
Inflammatory markers-delirium-day5
Time frame: 5 days
Inflammatory markers-delirium-day5
Time frame: 5 days
Inflammatory markers2-delirium-2
Time frame: 2 days
Inflammatory markers2-delirium-2
Time frame: 2 days
Inflammatory markers2-delirium-2
Time frame: 2 days
Inflammatory markers2-delirium-2
Time frame: 2 days
Inflammatory markers2-delirium-2
Time frame: 2 days
Inflammatory markers2-delirium-5
Time frame: 5 days
Inflammatory markers5-delirium-5
Time frame: 5 days
Inflammatory markers5-delirium-5
Time frame: 5 days
Inflammatory markers5-delirium-5
Time frame: 5 days
Inflammatory markers5-delirium-5
Time frame: 5 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
- Results publication: PubMed 11445689Ely EW, Margolin R, Francis J, May L, Truman B, Dittus R, Speroff T, Gautam S, Bernard GR, Inouye SK. Evaluation of delirium in critically ill patients: validation of the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU). Crit Care Med. 2001 Jul;29(7):1370-9. doi: 10.1097/00003246-200107000-00012.
- Results publication: PubMed 22091567Leslie DL, Inouye SK. The importance of delirium: economic and societal costs. J Am Geriatr Soc. 2011 Nov;59 Suppl 2(Suppl 2):S241-3. doi: 10.1111/j.1532-5415.2011.03671.x.
- Results publication: PubMed 11154118Rouhiainen A, Imai S, Rauvala H, Parkkinen J. Occurrence of amphoterin (HMG1) as an endogenous protein of human platelets that is exported to the cell surface upon platelet activation. Thromb Haemost. 2000 Dec;84(6):1087-94.
- Results publication: PubMed 24162463Vacas S, Degos V, Tracey KJ, Maze M. High-mobility group box 1 protein initiates postoperative cognitive decline by engaging bone marrow-derived macrophages. Anesthesiology. 2014 May;120(5):1160-7. doi: 10.1097/ALN.0000000000000045.
- Results publication: PubMed 29452810Hu J, Feng X, Valdearcos M, Lutrin D, Uchida Y, Koliwad SK, Maze M. Interleukin-6 is both necessary and sufficient to produce perioperative neurocognitive disorder in mice. Br J Anaesth. 2018 Mar;120(3):537-545. doi: 10.1016/j.bja.2017.11.096. Epub 2018 Feb 3.
- Results publication: PubMed 22190370Terrando N, Eriksson LI, Ryu JK, Yang T, Monaco C, Feldmann M, Jonsson Fagerlund M, Charo IF, Akassoglou K, Maze M. Resolving postoperative neuroinflammation and cognitive decline. Ann Neurol. 2011 Dec;70(6):986-995. doi: 10.1002/ana.22664.
- Results publication: PubMed 20818791Cibelli M, Fidalgo AR, Terrando N, Ma D, Monaco C, Feldmann M, Takata M, Lever IJ, Nanchahal J, Fanselow MS, Maze M. Role of interleukin-1beta in postoperative cognitive dysfunction. Ann Neurol. 2010 Sep;68(3):360-8. doi: 10.1002/ana.22082.
- Results publication: PubMed 28405620Feng X, Valdearcos M, Uchida Y, Lutrin D, Maze M, Koliwad SK. Microglia mediate postoperative hippocampal inflammation and cognitive decline in mice. JCI Insight. 2017 Apr 6;2(7):e91229. doi: 10.1172/jci.insight.91229.
- Results publication: PubMed 31049563Saxena S, Lai IK, Li R, Maze M. Neuroinflammation is a putative target for the prevention and treatment of perioperative neurocognitive disorders. Br Med Bull. 2019 Jun 19;130(1):125-135. doi: 10.1093/bmb/ldz010.
- Results publication: PubMed 30772915Ishihara T, Yoshida M, Arita M. Omega-3 fatty acid-derived mediators that control inflammation and tissue homeostasis. Int Immunol. 2019 Aug 23;31(9):559-567. doi: 10.1093/intimm/dxz001.
- Results publication: PubMed 30770053Yang T, Xu G, Newton PT, Chagin AS, Mkrtchian S, Carlstrom M, Zhang XM, Harris RA, Cooter M, Berger M, Maddipati KR, Akassoglou K, Terrando N. Maresin 1 attenuates neuroinflammation in a mouse model of perioperative neurocognitive disorders. Br J Anaesth. 2019 Mar;122(3):350-360. doi: 10.1016/j.bja.2018.10.062. Epub 2018 Dec 28.
- Results publication: PubMed 23709617Terrando N, Gomez-Galan M, Yang T, Carlstrom M, Gustavsson D, Harding RE, Lindskog M, Eriksson LI. Aspirin-triggered resolvin D1 prevents surgery-induced cognitive decline. FASEB J. 2013 Sep;27(9):3564-71. doi: 10.1096/fj.13-230276. Epub 2013 May 24.
- Individual participant dataSharing planned: No. IPD will be made available, anonymously, if needed
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The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
RecruitingPhase 3
Lactium Premedication to Prevent Emergence Agitation
Lactium, Premedication
Not yet recruiting
DEXmedetomidine for Postoperative Analgesia and Delirium Prevention After NEUROsurgery (DEX-NEURO Trial)
Neurosurgery, Brain Cancer
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.
Michael Piagnerelli, MD; PHD study chair
CHU de Charleroi, Belgium
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 Delirium, run by Université Libre de Bruxelles at 1 site in Belgium.
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 6 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: withdrawn, as of the sponsor's last update on 30 Mar 2025. 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 Belgium. 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 withdrawn before enrolling participants, so there are no results.
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?
The influence of serum levels of resolvins (RvD1) at ICU admission, and ICU day 2 and day 5 on cognitive impairment (defined by CAM-ICU) on day 5 of ICU stay. (time frame: 5 days). The study lists 3 primary outcomes in all. 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 NCT04575753, which also lists 13 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 30 Mar 2025.