Elderly Patient (80 Years Old or More) Admitted to Intensive CareNUAGENCT05233267
Neopterin on Admission to Intensive Care Unit
An observational study of Elderly Patient (80 Years Old or More) Admitted to Intensive Care, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
For the last twenty years, the proportion of patients aged 80 years and more, hospitalized in intensive care (ICU) has been increasing. The question of the admission of an elderly patient in intensive care raises many medico-socio-economic questions. Read more about this study
- Who is it for?
- Ages 80 years and older
- Conditions the study is for
- Elderly Patient (80 Years Old or More) Admitted to Intensive Care
- What is being tested?
- Blood sample
- How many people
- 313 participants
- Where
- 1 siteFrance
- Study dates
- 21 Nov 2022to Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 80 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: The population is selected from 80-year-old patients or more attending intensive care unit for less than 24 hours.
Who may be able to join
- Age ≥ 80 years old
- Admission to intensive care unit before 24 hours
- Non opposition expressed by the participant or its relative/trusty person, or emergency inclusion procedure
Who cannot join
- Hospitalisation for a scheduled surgery
- New admission within a month before previous stay to intensive care unit
- Active solid cancer or malignant hemopathy
- Immunosuppressant treatment (including corticotherapy > 5 mg/d)
- Autoimmune disease
- Tutorship or curatorship
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neopterin on Admission to the ICU: an Immunological Biomarker That Could Help Admission Decisions by Identifying Elderly Patients (≥80 Years) Able to Survive an ICU Stay Without Disability
For the last twenty years, the proportion of patients aged 80 years and more, hospitalized in intensive care (ICU) has been increasing. The question of the admission of an elderly patient in intensive care raises many medico-socio-economic questions. The general objective of geriatric management is to improve the survival of the patient by maintaining his autonomy. Before an invasive management, it is therefore important to assess which patients are capable of surviving in good conditions. Moreover, as intensive care resources are not extensible, it is important to rationalise the use of this type of care. To date, there are no reliable criteria for predicting which patients will benefit from ICU care. The use of a predictive biomarker, in addition to the existing scores which are not very effective in this population, could guide the intensive care physician in his decision which is generally made in the emergency.
The hypothesis of the study is that neopterin measured on admission of the elderly patient to the ICU may improve prediction of survival without major loss of autonomy at 3 months. Acute stress induced by a serious pathology has a profound impact on the immune system via the activation of the neuroendocrine system and the production of endogenous cortisol. Usually, cortisol inhibits the production of pro-inflammatory cytokines such as interferon gamma (IFNg). Sometimes this inhibition is ineffective and leads to an intense pro-inflammatory state that is harmful to the body. Neopterin is produced by monocytes/macrophages under the influence of IFNg. It is associated with a poor prognosis in many diseases such as sepsis or cancer. In the comorbid elderly patient with an upper femoral fracture, the pre-operative neopterin level is predictive of one-year mortality and functional recovery.
Read more
The hypothesis of the study is that neopterin measured on admission of the elderly patient to the ICU may improve prediction of survival without major loss of autonomy at 3 months.
Each patient will be included on admission to the intensive care unit within a maximum of 24 hours (D0). Demographic data (age, sex), severity (IGSIII), comorbidity (CIRS), autonomy (ADL and IADL) and frailty (CFS) scores will be collected as well as the diagnosis at admission.
Two additional tubes will be collected during the entry assessment (performed as part of usual care) at inclusion (D0) for neopterin and other biomarkers (4 ml dry tube and 10 ml lithium heparin tube). The blood tubes will be transferred to the research laboratory within 48 hours after sampling. The determination of neopterin, cytokines and oxidative stress biomarkers will be performed by an enzyme-linked immunosorbent assay (Neopterin ELISA Kit CE-IVD, Tecan laboratory) at the Centre d'Immunologie et des Maladies Infectieuses (CIMI-Paris).
The assays will be performed at the end of the study, blinded to the patient's outcome, and the follow-up of the patients will be performed blinded to the results of the neopterin assay and the other markers.
Patients will be followed up at 3 months from inclusion (M3). The follow-up data will be collected during a routine geriatric consultation. During this consultation, the scores of comorbidities (CIRS), autonomy (ADL and IADL) and frailty (CFS) will be collected. An assessment of physical performance will be carried out by measuring the Short Physical Performance Battery (SPPBS) and the "Handgrip". If it is impossible to carry out the consultation (patient unable to move), the follow-up data (CIRS, ADL and CFS) will be collected from the patient or his relatives during a phone interview conducted by a clinical research technician.
- Being tested
- Blood sample
- Keywords
- neopterin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleOther
Dosage of neopterin
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival without significant loss of autonomy
Autonomy is evaluated by Activities of Daily Living score (ADL). This score is based on a 6-item questionnaire. Each item is rated 0, 0.5 or 1. 1 is the best outcome.
A significant loss of autonomy is defined by a ADL score at 3 month after inclusion lower by more than 1 point compared to the ADL score before hospitalization.
Measured: Month 3
Secondary outcomes (6)
Intra-hospital mortality
Measured: Month 3
Mortality
Measured: Month 3
Functional autonomy
Instrumental Activities of Daily Living score (IADL).This score is based on a 4-item questionnaire. Each item is rated 0 or 1. 1 is the best outcome.
Measured: Month 3
Short Physical Performance Battery
The score is from 0 to 12 based on the result of three exercises: Balance, gait speed and chair stand. 12 means better outcome.
Measured: Month 3
Handgrip test
Measured: Month 3
Neopterin
The concentration of neopterin is measured in blood.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2022
- Study start21 Nov 2022
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elderly Patient (80 Years Old or More) Admitted to Intensive CareStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- 313 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hélène VALLET, MD, Principal investigator, Hôpital Saint-Antoine - APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05233267
- Sponsor's protocol ID
- APHP210083
- Other IDs
- 2021-A02264-37
- Acronym
- NUAGE
- Status last verified
- Jul 2026
- First submitted
- 9 Feb 2022
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neopterin on Admission to the ICU: an Immunological Biomarker That Could Help Admission Decisions by Identifying Elderly Patients (≥80 Years) Able to Survive an ICU Stay Without Disability
- ClinicalTrials.gov ID
- NCT05233267
- Acronym / sponsor ID
- NUAGE / APHP210083
- Keywords
- neopterin
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 313 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- 21 Nov 2022 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 10 Feb 2022 (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.
For the last twenty years, the proportion of patients aged 80 years and more, hospitalized in intensive care (ICU) has been increasing. The question of the admission of an elderly patient in intensive care raises many medico-socio-economic questions. The general objective of geriatric management is to improve the survival of the patient by maintaining his autonomy. Before an invasive management, it is therefore important to assess which patients are capable of surviving in good conditions. Moreover, as intensive care resources are not extensible, it is important to rationalise the use of this type of care. To date, there are no reliable criteria for predicting which patients will benefit from ICU care. The use of a predictive biomarker, in addition to the existing scores which are not very effective in this population, could guide the intensive care physician in his decision which is generally made in the emergency.
The hypothesis of the study is that neopterin measured on admission of the elderly patient to the ICU may improve prediction of survival without major loss of autonomy at 3 months. Acute stress induced by a serious pathology has a profound impact on the immune system via the activation of the neuroendocrine system and the production of endogenous cortisol. Usually, cortisol inhibits the production of pro-inflammatory cytokines such as interferon gamma (IFNg). Sometimes this inhibition is ineffective and leads to an intense pro-inflammatory state that is harmful to the body. Neopterin is produced by monocytes/macrophages under the influence of IFNg. It is associated with a poor prognosis in many diseases such as sepsis or cancer. In the comorbid elderly patient with an upper femoral fracture, the pre-operative neopterin level is predictive of one-year mortality and functional recovery.
The hypothesis of the study is that neopterin measured on admission of the elderly patient to the ICU may improve prediction of survival without major loss of autonomy at 3 months.
Each patient will be included on admission to the intensive care unit within a maximum of 24 hours (D0). Demographic data (age, sex), severity (IGSIII), comorbidity (CIRS), autonomy (ADL and IADL) and frailty (CFS) scores will be collected as well as the diagnosis at admission.
Two additional tubes will be collected during the entry assessment (performed as part of usual care) at inclusion (D0) for neopterin and other biomarkers (4 ml dry tube and 10 ml lithium heparin tube). The blood tubes will be transferred to the research laboratory within 48 hours after sampling. The determination of neopterin, cytokines and oxidative stress biomarkers will be performed by an enzyme-linked immunosorbent assay (Neopterin ELISA Kit CE-IVD, Tecan laboratory) at the Centre d'Immunologie et des Maladies Infectieuses (CIMI-Paris).
The assays will be performed at the end of the study, blinded to the patient's outcome, and the follow-up of the patients will be performed blinded to the results of the neopterin assay and the other markers.
Patients will be followed up at 3 months from inclusion (M3). The follow-up data will be collected during a routine geriatric consultation. During this consultation, the scores of comorbidities (CIRS), autonomy (ADL and IADL) and frailty (CFS) will be collected. An assessment of physical performance will be carried out by measuring the Short Physical Performance Battery (SPPBS) and the "Handgrip". If it is impossible to carry out the consultation (patient unable to move), the follow-up data (CIRS, ADL and CFS) will be collected from the patient or his relatives during a phone interview conducted by a clinical research technician.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 80 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- The population is selected from 80-year-old patients or more attending intensive care unit for less than 24 hours.
Key inclusion criteria (3 listed)
- Age ≥ 80 years old
- Admission to intensive care unit before 24 hours
- Non opposition expressed by the participant or its relative/trusty person, or emergency inclusion procedure
Key exclusion criteria (6 listed)
- Hospitalisation for a scheduled surgery
- New admission within a month before previous stay to intensive care unit
- Active solid cancer or malignant hemopathy
- Immunosuppressant treatment (including corticotherapy > 5 mg/d)
- Autoimmune disease
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 |
|---|---|---|
| Blood sampleDosage of neopterin | Other | – |
Primary outcome
Survival without significant loss of autonomy
Time frame: Month 3
Autonomy is evaluated by Activities of Daily Living score (ADL). This score is based on a 6-item questionnaire. Each item is rated 0, 0.5 or 1. 1 is the best outcome. A significant loss of autonomy is defined by a ADL score at 3 month after inclusion lower by more than 1 point compared to the ADL score before hospitalization.
6 secondary outcomes
Intra-hospital mortality
Time frame: Month 3
Mortality
Time frame: Month 3
Functional autonomy
Time frame: Month 3
Short Physical Performance Battery
Time frame: Month 3
Handgrip test
Time frame: Month 3
Neopterin
Time frame: Day 0
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
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.
Hélène VALLET, MD principal investigator
Hôpital Saint-Antoine - APHP
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 Elderly Patient (80 Years Old or More) Admitted to Intensive Care, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 3 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: under way, not looking for participants, as of the sponsor's last update on 13 Jul 2026. 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 France. 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?
This study is still under way. Results are not available in the source record yet.
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?
Survival without significant loss of autonomy (time frame: Month 3). 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 13 Jul 2026.