Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The goal of this observational study is to determine the effects of chromium serum levels on glucose metabolism, lipid metabolism, morbidity and mortality rates in critically ill intensive care patients. The investigators' goal is to provide a different perspective on solving the common problems of hyperglycemia and dyslipidemia encountered in intensive care patients, aiming to reduce morbidity and mortality rates.
Participants will give a single blood sample (into trace element serum sample tube) on the day of admission to the intensive care unit, along with routine blood tests, and samples will be taken once a week during their stay in the intensive care unit.
Hyperglycemia is a common risk factor in critically ill patients admitted to intensive care units; increasing hospital stay duration, morbidity/mortality rates and is associated with increased undesirable cardiovascular events, thrombosis, inflammatory changes, impaired immune functions, increased infection frequency, delayed wound healing, osmotic diuresis, fluid - electrolyte imbalances and other issues.
Dyslipidemia plays a significant role in the development of atherosclerosis and consequently cardiovascular disease.
Chromium (Cr) is a trace metal. It has been claimed that trivalent chromium is a cofactor of a low molecular weight chromium - binding substance (LMWCr; also known as chromodulin), an oligopeptide. LMWCr can enhance the action of insulin, thereby improving tissue insulin sensitivity and facilitating glucose transport into the cells. This hypothesis is supported by observations that chromium deficiency leads to an increase in blood sugar, total cholesterol and triglycerides; a decrease in high - density lipoproteins (HDL) and insulin sensitivity.
Patients aged 18 and older admitted to the Intensive Care Unit of Hacettepe University Department of Anesthesiology will be included in the study. A single blood sample (into trace element serum sample tube) will be taken from participants in the study group on the day of admission to the intensive care unit, along with routine blood tests, and samples will be taken once a week during their stay in the intensive care unit. The chromium level in the collected blood samples will be analyzed using inductively coupled plasma - mass spectrometry (ICP - MS). The laboratory results of the monitored participants will be prospectively recorded in the data collection form and in International Business Machines Statistical Product and Service Solutions (IBM SPSS).
A literature review revealed very few publications on the effects of chromium serum levels on glucose metabolism, lipid metabolism, morbidity and mortality rates; and the existing publications did not include samples of critically ill intensive care patients. With this study, the investigators aim to contribute to the national and international literature with a large sample of intensive care patients. Thus, the investigators' goal is to provide a different perspective on solving the common problems of hyperglycemia and dyslipidemia encountered in intensive care patients, aiming to reduce morbidity and mortality rates.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intensive Care Patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Serum Chromium Level | Diagnostic Test | Measuring serum chromium levels from patients who admitted in intensive care unit. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Serum Chromium Level | Serum chromium levels of participants were measured once a week throughout the participant's ICU stay, starting from admission. The healthy reference range of 0.7 to 28.0 µg/L for blood chromium levels was used. | Once a week throughout the participant's ICU stay, starting from admission (day 0, day 7, day 14 and day 21). |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c | The HbA1c level when the participant is admitted to the intensive care unit. Possible levels are less/equal/more than %6,5. | At the time of ICU admission (day 0). |
| Blood Glucose | During the ICU stay, participants underwent daily blood glucose measurements using the fingertip method. Weekly averages of the measurements were calculated. Although there is no accepted definition of acute hyperglycemia in the critical care setting, it is generally considered to be above 180 - 220 mg/dL. In our study, we considered the value of 200 mg/dL as a threshold for stress hyperglycemia. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Every patient; who is over/and 18 years old age, admitted to Anesthesiology Intensive Care Unit, agreed to participate in the study (with informed consent) and not - taking chromium supplement
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hacettepe University | Ankara | 06230 | Turkey (Türkiye) |
We will discuss this matter with all the researchers and ethics committee.
Not provided
Not provided
Not provided
Not provided
All of the enrolled participants were included in the study.
Patients who were admitted to the anesthesiology intensive care unit and met the inclusion criteria were recruited between February 2024 and August 2024. The first participant was enrolled on February 7, 2024, and the last participant was enrolled, and primary outcome data collection was completed on August 8, 2024. The study was fully completed on August 14, 2024, following the collection of all secondary outcomes.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Intensive Care Patients | Patients who are admitted to the intensive care unit. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 24, 2024 |
Not provided
Not provided
Not provided
Not provided
| Week 1, week 2, week 3 and week 4. |
| Lipid Profile | Lipid Profiles (HDL, LDL, Triglycerides, Total Cholesterol) of participants were measured once a week throughout the participant's ICU stay, starting from admission. The optimal lipid levels vary depending on age, gender, and other risk factors; however, they are generally recommended within the following ranges:
| Once a week throughout the participant's ICU stay, starting from admission (day 0, day 7, day 14 and day 21). |
| Glycemic Variability - Coefficient of Variation (CV) | The coefficient of variation (CV) is the standard deviation divided by the mean of the glycemic values. A higher coefficient of variation is associated with greater glycemic variability. A CV of < 36% is a good threshold. The coefficients of variation were calculated after each participant was discharged from the ICU, based on all the blood glucose values measured during their stay. | During each participant's ICU stay (ranging from 1 to 4 weeks). |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Intensive Care Patients | Patients who are admitted to the intensive care unit. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| |||||||||||||||||
| Height | Mean | Standard Deviation | Centimeters |
| |||||||||||||||||
| Body Mass | Mean | Standard Deviation | Kilograms |
| |||||||||||||||||
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m2 |
| |||||||||||||||||
| Comorbidities | Number | participants |
| ||||||||||||||||||
| Reason for Intensive Care Admission | Count of Participants | Participants |
| ||||||||||||||||||
| SOFA Score | The Sequential Organ Failure Assessment (SOFA) score is a simple method of assessing and monitoring organ dysfunction in critically ill patients. Each organ system (neurologic, blood, liver, kidney, and blood pressure/hemodynamics) receives a score ranging from 0 (normal) to 4 (most abnormal), with a minimum SOFA score of 0 and a maximum SOFA score of 24. The higher the SOFA score, the higher the likely mortality. | Mean | Standard Deviation | Scores on a scale |
| ||||||||||||||||
| APACHE - II Score | Acute Physiology and Chronic Health Evaluation - II (APACHE - II) score is a general measure of disease severity based on current physiologic measurements (body temperature, heart and respiratory rate, mean arterial pressure, pH), age & previous health conditions. The score can help in the assessment of patients to determine the level and degree of diagnostic and therapeutic intervention. The range of APACHE - II score is 0 (minimum) to 71 (maximum); increasing score is associated with an increasing risk of hospital death. | Mean | Standard Deviation | Scores on a scale |
| ||||||||||||||||
| Nutritional Status | Nutritional statuses of patients were recorded to examine its effects on serum chromium levels and also, mortality. | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Serum Chromium Level | Serum chromium levels of participants were measured once a week throughout the participant's ICU stay, starting from admission. The healthy reference range of 0.7 to 28.0 µg/L for blood chromium levels was used. | A total of 309 participants were included in the study. Measurements were taken once a week throughout their hospital stay. In the first measurement (ICU admission/day 0), 309 participants; in the second measurement (participants who completed the 7th day of ICU stay), 51 participants; in the third measurement (participants who completed the 14th day of ICU stay), 24 participants; and in the fourth measurement (participants who completed the 21st day of ICU stay), 13 participants were assessed. | Posted | Mean | Standard Deviation | µg/L | Once a week throughout the participant's ICU stay, starting from admission (day 0, day 7, day 14 and day 21). |
|
|
| |||||||||||||||||||||||||||
| Secondary | HbA1c | The HbA1c level when the participant is admitted to the intensive care unit. Possible levels are less/equal/more than %6,5. | Posted | Mean | Standard Deviation | Percentage of glycated hemoglobin (%) | At the time of ICU admission (day 0). |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Blood Glucose | During the ICU stay, participants underwent daily blood glucose measurements using the fingertip method. Weekly averages of the measurements were calculated. Although there is no accepted definition of acute hyperglycemia in the critical care setting, it is generally considered to be above 180 - 220 mg/dL. In our study, we considered the value of 200 mg/dL as a threshold for stress hyperglycemia. | Posted | Mean | Standard Deviation | mg/dL | Week 1, week 2, week 3 and week 4. |
|
| |||||||||||||||||||||||||||||
| Secondary | Lipid Profile | Lipid Profiles (HDL, LDL, Triglycerides, Total Cholesterol) of participants were measured once a week throughout the participant's ICU stay, starting from admission. The optimal lipid levels vary depending on age, gender, and other risk factors; however, they are generally recommended within the following ranges:
| A total of 309 participants were included in the study. Measurements were taken once a week throughout their hospital stay. In the first measurement (ICU admission/day 0), 309 participants; in the second measurement (participants who completed the 7th day of ICU stay), 51 participants; in the third measurement (participants who completed the 14th day of ICU stay), 24 participants; and in the fourth measurement (participants who completed the 21st day of ICU stay), 13 participants were assessed. | Posted | Mean | Standard Deviation | mg/dL | Once a week throughout the participant's ICU stay, starting from admission (day 0, day 7, day 14 and day 21). |
|
| ||||||||||||||||||||||||||||
| Secondary | Glycemic Variability - Coefficient of Variation (CV) | The coefficient of variation (CV) is the standard deviation divided by the mean of the glycemic values. A higher coefficient of variation is associated with greater glycemic variability. A CV of < 36% is a good threshold. The coefficients of variation were calculated after each participant was discharged from the ICU, based on all the blood glucose values measured during their stay. | Posted | Mean | Standard Deviation | Percentage of coefficient of variation | During each participant's ICU stay (ranging from 1 to 4 weeks). |
|
|
All - cause mortality, serious, and other (not including serious) adverse events were not monitored/assessed.
All - cause mortality, serious, and other (not including serious) adverse events were not monitored/assessed.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intensive Care Patients | Patients who are admitted to the intensive care unit. | 0 | 0 | 0 | 0 | 0 | 0 |
Not provided
Not provided
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Oguzhan Kahveci, MD | Hacettepe University Department of Anesthesiology and Intensive Care | +903123051207 | kahveci.oguz@hotmail.com |
| Dec 24, 2024 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D006949 | Hyperlipidemias |
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
Not provided
Not provided
|
| Malignancy |
|
|
| Neurological Disorders |
|
|
| Respiratory Diseases |
|
|
| Liver Diseases |
|
|
|
| Sepsis |
|
| Neurological Disorders |
|
| Trauma |
|
| Drug Intoxication |
|
| Parenteral |
|
| Enteral and Parenteral |
|
|
| Third Measurement (Day 14) |
|
|
| Fourth Measurement (Day 21) |
|
|
| Denominators |
|---|
| Categories |
|---|
|
|
|
|