Ignite Creation Date:
2024-05-06 @ 5:12 PM
Last Modification Date:
2024-10-26 @ 2:24 PM
Study NCT ID:
NCT05233267
Status:
RECRUITING
Last Update Posted:
2023-05-06
First Post:
2022-02-09
Brief Title:
Neopterin on Admission to Intensive Care Unit
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NUAGE
Brief 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 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 monocytesmacrophages 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 dImmunologie et des Maladies Infectieuses CIMI-Paris
The assays will be performed at the end of the study blinded to the patients 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
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 monocytesmacrophages 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 dImmunologie et des Maladies Infectieuses CIMI-Paris
The assays will be performed at the end of the study blinded to the patients 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2021-A02264-37 | REGISTRY | DRCB | None |