FrailityNCT07143084
Investigation of the Relationship Between Nutritional Status Assessment and Frailty in Critical Care Patients
An observational study of Fraility and Critical Illness, run by Ankara Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study aims to understand the effects of these two parameters on clinical outcomes by examining the relationship between NUTRIC and CONUT scores in intensive care patients. The results of the study may contribute to the development of new approaches to the treatment process of patients by better understanding the… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Fraility, Critical Illness
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 May 2025to 1 May 2027
- How long will I take part?
- 2 Days
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Over 65 years, critically ill patients, who are submitted to ICU.
Who may be able to join
- over 65
- 48 hours min. ICU stay
Who cannot join
- Patients who are under 65 years of age
- whose intensive care stay does not exceed 48 hours
- who have missing data for serum albumin or lymphocyte count or total cholesterol,
- who have been diagnosed with hematological diseases such as leukemia or lymphoma
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Ankara Training And Research Hospital
Altındağ, Ankara, 06230
About this study
This study aims to understand the effects of these two parameters on clinical outcomes by examining the relationship between NUTRIC and CONUT scores in intensive care patients. The results of the study may contribute to the development of new approaches to the treatment process of patients by better understanding the relationship between nutritional status and pre-hospital frailty in intensive care units. In addition, eliminating the deficiencies in this area will pave the way for the creation of more effective and personalized treatment plans for similar patients.
- Conditions
- Fraility, Critical Illness
- Keywords
- CONUT, Fraility, NUTRIC Score
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ICU Patients above 65 years old | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between CONUT scale and frailty in intensive care patients
To evaluate the correlation between the CONUT scale and frailty, Pearson or Spearman correlation analysis will be performed depending on suitability for normal distribution. Logistic regression analysis will be performed to assess the independent association between CONUT scale and frailty. Potential confounding variables such as age, gender, APACHE II score, and activities of daily living will be included in the regression model.
Measured: From enrollment 2 days
Secondary outcomes (1)
Association of NUTRIC score and CONUT scale with clinical outcomes
To evaluate the correlation between the NUTRIC score and CONUT scale with clinical outcome, Pearson or Spearman correlation analysis will be performed depending on suitability for normal distribution. Logistic regression analysis will be performed to assess the independent association between CONUT scale and NUTRIC score. Potential confounding variables such as age, gender, APACHE II score, and activities of daily living will be included in the regression model.
Measured: From enrollment to through study completion an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2025
- Study start15 May 2025
- Primary completion15 Dec 2026 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for FrailityStudies 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
- 100 participants (estimated)
- Target duration
- 2 Days
Sponsor and investigators
- Lead sponsor
- Ankara Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayşe EKEN, Ankara Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07143084
- Sponsor's protocol ID
- 02.05.2025_E-25-426
- Status last verified
- Mar 2026
- First submitted
- 25 Jun 2025
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Auza-Santivañez, J. C., Perez, J. S., Lara, Y. D., León, D. O., Condori-Villca, N., & Loaces, J. P. A. Predictive value of the CONUT scale in the early detection of nutritional risk and its relationship with mortality in critically ill patients.
Kos, M., Titiz, H., Onec, B., Soysal, T., Kutlucan, A., Emen, S. S., & Kutlucan, L. (2016). Association of "controlling nutritional status index" and "prognostic nutritional index" with intensive care unit survival in elderly patients. European Geriatric Medicine, 7(1), 13-17.
Lo Buglio A, Bellanti F, Capurso C, Vendemiale G. Controlling Nutritional Status (CONUT) Score as a Predictive Marker in Hospitalized Frail Elderly Patients. J Pers Med. 2023 Jul 10;13(7):1119. doi: 10.3390/jpm13071119.
PubMed 37511732
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Relationship Between Nutritional Status Assessment and Frailty in Critical Care Patients
- ClinicalTrials.gov ID
- NCT07143084
- Acronym / sponsor ID
- 02.05.2025_E-25-426
- Conditions
- Fraility, Critical Illness
- Keywords
- CONUT, Fraility, NUTRIC Score
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ankara Training and Research HospitalUniversity, hospital or other
- Study start
- 15 May 2025 (actual)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 27 Aug 2025 (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 aims to understand the effects of these two parameters on clinical outcomes by examining the relationship between NUTRIC and CONUT scores in intensive care patients. The results of the study may contribute to the development of new approaches to the treatment process of patients by better understanding the relationship between nutritional status and pre-hospital frailty in intensive care units. In addition, eliminating the deficiencies in this area will pave the way for the creation of more effective and personalized treatment plans for similar patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICU Patients above 65 years old | – | – |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Over 65 years, critically ill patients, who are submitted to ICU.
Key inclusion criteria (2 listed)
- over 65
- 48 hours min. ICU stay
Key exclusion criteria (4 listed)
- Patients who are under 65 years of age
- whose intensive care stay does not exceed 48 hours
- who have missing data for serum albumin or lymphocyte count or total cholesterol,
- who have been diagnosed with hematological diseases such as leukemia or lymphoma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation between CONUT scale and frailty in intensive care patients
Time frame: From enrollment 2 days
To evaluate the correlation between the CONUT scale and frailty, Pearson or Spearman correlation analysis will be performed depending on suitability for normal distribution. Logistic regression analysis will be performed to assess the independent association between CONUT scale and frailty. Potential confounding variables such as age, gender, APACHE II score, and activities of daily living will be included in the regression model.
1 secondary outcome
Association of NUTRIC score and CONUT scale with clinical outcomes
Time frame: From enrollment to through study completion an average of 1 year
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 19 Mar 2026.
- BackgroundAuza-Santivañez, J. C., Perez, J. S., Lara, Y. D., León, D. O., Condori-Villca, N., & Loaces, J. P. A. Predictive value of the CONUT scale in the early detection of nutritional risk and its relationship with mortality in critically ill patients.
- BackgroundKos, M., Titiz, H., Onec, B., Soysal, T., Kutlucan, A., Emen, S. S., & Kutlucan, L. (2016). Association of "controlling nutritional status index" and "prognostic nutritional index" with intensive care unit survival in elderly patients. European Geriatric Medicine, 7(1), 13-17.
- Background: PubMed 37511732Lo Buglio A, Bellanti F, Capurso C, Vendemiale G. Controlling Nutritional Status (CONUT) Score as a Predictive Marker in Hospitalized Frail Elderly Patients. J Pers Med. 2023 Jul 10;13(7):1119. doi: 10.3390/jpm13071119.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Fraility and Critical Illness, run by Ankara Training and Research Hospital at 1 site in Turkey (Türkiye).
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 2 inclusion and 4 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: enrolling by invitation, as of the sponsor's last update on 19 Mar 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 Turkey (Türkiye). 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?
Correlation between CONUT scale and frailty in intensive care patients (time frame: From enrollment 2 days). 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 NCT07143084, which also lists 3 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 19 Mar 2026.