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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.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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
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.

France1 site
  • Hôpital Saint-Antoine / Service de réanimation

    Paris, 75012

Other trials in France

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.

  1. 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)
  1. Intra-hospital mortality

    Measured: Month 3

  2. Mortality

    Measured: Month 3

  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

  4. 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

  5. Handgrip test

    Measured: Month 3

  6. 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.

  1. First posted10 Feb 2022
  2. Study start21 Nov 2022
  3. Primary completionSep 2026 (estimated)
  4. Study completionSep 2026 (estimated)

Resources

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)
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

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.

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