Trial Outcomes & Findings for Examination of the Effects of Chromium Levels on Glucose Metabolism, Lipid Metabolism, Morbidity and Mortality Rates in Patients Followed in Intensive Care Unit (NCT NCT06334042)

Last Updated: 2025-04-13

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

309 participants

Primary outcome timeframe

Once a week throughout the participant's ICU stay, starting from admission (day 0, day 7, day 14 and day 21).

Results posted on

2025-04-13

Participant Flow

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.

All of the enrolled participants were included in the study.

Participant milestones

Participant milestones
Measure	Intensive Care Patients Patients who are admitted to the intensive care unit.
Overall Study STARTED	309
Overall Study COMPLETED	309
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intensive Care Patients n=309 Participants Patients who are admitted to the intensive care unit.
Age, Continuous	63.72 Years STANDARD_DEVIATION 16.92 • n=309 Participants
Sex: Female, Male Female	167 Participants n=309 Participants
Sex: Female, Male Male	142 Participants n=309 Participants
Height	165.21 Centimeters STANDARD_DEVIATION 9.03 • n=309 Participants
Body Mass	73.8 Kilograms STANDARD_DEVIATION 15.81 • n=309 Participants
Body Mass Index (BMI)	27 kg/m2 STANDARD_DEVIATION 5.36 • n=309 Participants
Comorbidities Cardiovascular Diseases	202 participants n=309 Participants
Comorbidities Diabetes	89 participants n=309 Participants
Comorbidities Malignancy	79 participants n=309 Participants
Comorbidities Neurological Disorders	76 participants n=309 Participants
Comorbidities Respiratory Diseases	69 participants n=309 Participants
Comorbidities Liver Diseases	4 participants n=309 Participants
Reason for Intensive Care Admission Postoperative Care	216 Participants n=309 Participants
Reason for Intensive Care Admission Respiratory Distress	45 Participants n=309 Participants
Reason for Intensive Care Admission Sepsis	31 Participants n=309 Participants
Reason for Intensive Care Admission Neurological Disorders	10 Participants n=309 Participants
Reason for Intensive Care Admission Trauma	5 Participants n=309 Participants
Reason for Intensive Care Admission Drug Intoxication	2 Participants n=309 Participants
SOFA Score	0.91 Scores on a scale STANDARD_DEVIATION 1.77 • n=309 Participants
APACHE - II Score	9.33 Scores on a scale STANDARD_DEVIATION 5.65 • n=309 Participants
Nutritional Status Enteral	265 Participants n=309 Participants
Nutritional Status Parenteral	2 Participants n=309 Participants
Nutritional Status Enteral and Parenteral	42 Participants n=309 Participants

PRIMARY outcome

Timeframe: Once a week throughout the participant's ICU stay, starting from admission (day 0, day 7, day 14 and day 21).

Population: 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.

Outcome measures

Outcome measures
Measure	Intensive Care Patients n=309 Participants Patients who are admitted to the intensive care unit.
Serum Chromium Level First Measurement (Day 0)	8.93 µg/L Standard Deviation 5.18
Serum Chromium Level Second Measurement (Day 7)	9.74 µg/L Standard Deviation 5.31
Serum Chromium Level Third Measurement (Day 14)	9.68 µg/L Standard Deviation 4.41
Serum Chromium Level Fourth Measurement (Day 21)	11.01 µg/L Standard Deviation 4.03

SECONDARY outcome

Timeframe: At the time of ICU admission (day 0).

The HbA1c level when the participant is admitted to the intensive care unit. Possible levels are less/equal/more than %6,5.

Outcome measures

Outcome measures
Measure	Intensive Care Patients n=309 Participants Patients who are admitted to the intensive care unit.
HbA1c	5.99 Percentage of glycated hemoglobin (%) Standard Deviation 1.04

SECONDARY outcome

Timeframe: Week 1, week 2, week 3 and week 4.

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.

Outcome measures

Outcome measures
Measure	Intensive Care Patients n=309 Participants Patients who are admitted to the intensive care unit.
Blood Glucose First Measurement (Week 1)	128.68 mg/dL Standard Deviation 35.97
Blood Glucose Second Measurement (Week 2)	122.25 mg/dL Standard Deviation 27.43
Blood Glucose Third Measurement (Week 3)	122.29 mg/dL Standard Deviation 24.47
Blood Glucose Fourth Measurement (Week 4)	116.46 mg/dL Standard Deviation 30.8

SECONDARY outcome

Timeframe: Once a week throughout the participant's ICU stay, starting from admission (day 0, day 7, day 14 and day 21).

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: * LDL cholesterol: Less than 100 mg/dL, * HDL cholesterol: Greater than 40 mg/dL for men and greater than 50 mg/dL for women, * Triglycerides: Less than 150 mg/dL, * Total cholesterol: Less than 200 mg/dL.

Outcome measures

Outcome measures
Measure	Intensive Care Patients n=309 Participants Patients who are admitted to the intensive care unit.
Lipid Profile First Triglycerides Measurement (Day 0)	118.28 mg/dL Standard Deviation 74.21
Lipid Profile Second Triglycerides Measurement (Day 7)	135.06 mg/dL Standard Deviation 58.83
Lipid Profile Third Triglycerides Measurement (Day 14)	124.29 mg/dL Standard Deviation 57.62
Lipid Profile Fourth Triglycerides Measurement (Day 21)	145.23 mg/dL Standard Deviation 81.89
Lipid Profile First HDL Measurement (Day 0)	38.93 mg/dL Standard Deviation 12.08
Lipid Profile Second HDL Measurement (Day 7)	29.7 mg/dL Standard Deviation 11.92
Lipid Profile Third HDL Measurement (Day 14)	23.9 mg/dL Standard Deviation 12.63
Lipid Profile Fourth HDL Measurement (Day 21)	22.84 mg/dL Standard Deviation 11.01
Lipid Profile First LDL Measurement (Day 0)	92.34 mg/dL Standard Deviation 34.64
Lipid Profile Second LDL Measurement (Day 7)	75.1 mg/dL Standard Deviation 35.28
Lipid Profile Third LDL Measurement (Day 14)	57.51 mg/dL Standard Deviation 37.25
Lipid Profile Fourth LDL Measurement (Day 21)	57.69 mg/dL Standard Deviation 26.51
Lipid Profile First VLDL Measurement (Day 0)	23.86 mg/dL Standard Deviation 14.85
Lipid Profile Second VLDL Measurement (Day 7)	26.73 mg/dL Standard Deviation 12.29
Lipid Profile Third VLDL Measurement (Day 14)	24.77 mg/dL Standard Deviation 11.64
Lipid Profile Fourth VLDL Measurement (Day 21)	31.31 mg/dL Standard Deviation 23.04
Lipid Profile First Total Cholesterol Measurement (Day 0)	143.14 mg/dL Standard Deviation 45.79
Lipid Profile Second Total Cholesterol Measurement (Day 7)	116.14 mg/dL Standard Deviation 46.59
Lipid Profile Third Total Cholesterol Measurement (Day 14)	89.25 mg/dL Standard Deviation 55.01
Lipid Profile Fourth Total Cholesterol Measurement (Day 21)	82.92 mg/dL Standard Deviation 42.03

SECONDARY outcome

Timeframe: During each participant's ICU stay (ranging from 1 to 4 weeks).

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.

Outcome measures

Outcome measures
Measure	Intensive Care Patients n=309 Participants Patients who are admitted to the intensive care unit.
Glycemic Variability - Coefficient of Variation (CV)	22.01 Percentage of coefficient of variation Standard Deviation 12.24

Adverse Events

Intensive Care Patients

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Oguzhan Kahveci, MD

Hacettepe University Department of Anesthesiology and Intensive Care

Phone: +903123051207

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place