Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000450415
Ethics application status
Approved
Date submitted
13/09/2024
Date registered
13/05/2025
Date last updated
13/05/2025
Date data sharing statement initially provided
13/05/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Role of the CONUT Score in Assessing Malnutrition, Inflammation, and Mortality in Diabetic Patients Admitted to the Intensive Care Unit
Scientific title
The Role of the CONUT Score in Assessing Malnutrition, Inflammation, and Mortality in Diabetic Patients Admitted to the Intensive Care Unit
Secondary ID [1] 312722 0
nil known
Universal Trial Number (UTN)
U1111-1311-7245
Trial acronym
CONUT (Controlling Nutritional Status)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
diabetes mellitus 334743 0
Requirement for intensive care 334744 0
Condition category
Condition code
Metabolic and Endocrine 331304 331304 0 0
Diabetes

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The CONUT (Controlling Nutritional Status) score is a widely used screening tool for assessing the nutritional status of individuals in clinical practice. This score is calculated based on three biochemical parameters:
Serum albumin level: A marker of protein reserves.
Total lymphocyte count: An indicator of cellular immune function.
Total cholesterol level: A reflection of energy reserves.
The CONUT score is derived from the combination of these three parameters. A total CONUT score >2 is considered indicative of a risk for malnutrition, while a score of <2 is regarded as normal nutritional status.
Serum albumin concentration, total lymphocyte count and total cholesterol data will be recorded in blood samples collected from patients at designated time points on day 0, week 1, week 2 and month 1 during admission to the intensive care unit and throughout follow-up. In addition, the thickness of the rectus femoris muscle will be measured using ultrasound by an anesthesiologist who has performed at least 50 measurements.
Intervention code [1] 329245 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 339065 0
The primary outcome of the study is to evaluate the relationship between the admission CONUT score of diabetic patients and 1-month mortality. Since the CONUT score allows for the assessment of malnutrition, the relationship between patients' malnutrition status and 1-month mortality will also be examined.
Assessment method [1] 339065 0
Serum analysis results will be recorded at specified time points (day 0 - admission, week 1, week 2, month 1) for diabetic patients admitted to the intensive care unit. The CONUT score will be calculated based on the values of albumin (g/dL), total lymphocyte count (count/mm³), and total cholesterol (mg/dL). During the 1-month follow-up of the patients, ICU discharge and mortality status will be recorded.
Timepoint [1] 339065 0
Day 0 - admission day and 1 month after admission (primary timepoints)
Secondary outcome [1] 438460 0
The relationship between sarcopenia determined using rectus femoris muscle thickness and the CONUT score.
Assessment method [1] 438460 0
Rectus femoris muscle thickness measured by ultrasound
Timepoint [1] 438460 0
1 week after admission, 2 weeks after admission

Eligibility
Key inclusion criteria
-Patients aged between 18 and 99
-Patients diagnosed with diabetes
-Patients requiring ICU admission
Minimum age
18 Years
Maximum age
99 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
-Patients with a history of leukemia/lymphoma or a diagnosis of malignancy
-Patients with a history of drug use that may cause bone marrow depression
-Patients with a history of cirrhosis
-Pregnant women
-Patients with incomplete laboratory data
-Patient with dialysis

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/11/2024
Date of last participant enrolment
Anticipated
Actual
1/02/2025
Date of last data collection
Anticipated
Actual
1/03/2025
Sample size
Target
60
Accrual to date
Final
60
Recruitment outside Australia
Country [1] 26558 0
Turkey
State/province [1] 26558 0

Funding & Sponsors
Funding source category [1] 317151 0
Self funded/Unfunded
Name [1] 317151 0
Country [1] 317151 0
Primary sponsor type
Individual
Name
Berrak Sebil Aydin MD (Department of Anaesthesiology and Reanimation, Karadeniz Eregli Government Hospital)
Country
Turkey
Secondary sponsor category [1] 319419 0
None
Name [1] 319419 0
Country [1] 319419 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315902 0
Zonguldak Bülent Ecevit University Non-Interventional Clinical Research Ethics Committee
Ethics committee address [1] 315902 0
Ethics committee country [1] 315902 0
Turkey
Date submitted for ethics approval [1] 315902 0
11/09/2024
Approval date [1] 315902 0
16/10/2024
Ethics approval number [1] 315902 0
Ethics committee name [2] 316119 0
Zonguldak Bülent Ecevit University Non-Interventional Clinical Research Ethics Committee
Ethics committee address [2] 316119 0
Ethics committee country [2] 316119 0
Turkey
Date submitted for ethics approval [2] 316119 0
11/09/2024
Approval date [2] 316119 0
Ethics approval number [2] 316119 0

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 136154 0
Dr Berrak Sebil Aydin
Address 136154 0
Kdz. Eregli State Hospital Hastane Street, No: 1 Kdz. Eregli, Zonguldak Turkey Postal Code: 67300
Country 136154 0
Turkey
Phone 136154 0
+905058178141
Email 136154 0
drberraksebil@gmail.com
Contact person for public queries
Name 136155 0
Berrak Sebil Aydin
Address 136155 0
Kdz. Eregli State Hospital Hastane Street, No: 1 Kdz. Eregli, Zonguldak Turkey Postal Code: 67300
Country 136155 0
Turkey
Phone 136155 0
+905058178141
Email 136155 0
drberraksebil@gmail.com
Contact person for scientific queries
Name 136156 0
Berrak Sebil Aydin
Address 136156 0
Kdz. Eregli State Hospital Hastane Street, No: 1 Kdz. Eregli, Zonguldak Turkey Postal Code: 67300
Country 136156 0
Turkey
Phone 136156 0
+905058178141
Email 136156 0
drberraksebil@gmail.com

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Ethical approval    ethic.pdf


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.