跳至主要内容
临床试验/NCT06334042
NCT06334042已完成不适用

Examination of the Effects of Chromium Levels on Glucose Metabolism, Lipid Metabolism, Morbidity and Mortality Rates in Patients Followed in Intensive Care Unit

Oguzhan Kahveci1 个研究点 分布在 1 个国家目标入组 309 人开始时间: 2024年2月7日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
309
试验地点
1
主要终点
Serum Chromium Level

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥ 18 years old
  • Admitted to Anesthesiology Intensive Care Unit

排除标准

  • Patient Refusal
  • Taking Chromium Supplement

结局指标

主要结局

Serum Chromium Level

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

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.

次要结局

  • HbA1c(At the time of ICU admission (day 0).)
  • Blood Glucose(Week 1, week 2, week 3 and week 4.)
  • Lipid Profile(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)(During each participant's ICU stay (ranging from 1 to 4 weeks).)

研究者

发起方
Oguzhan Kahveci
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Oguzhan Kahveci

Anesthesiology Resident, MD

Hacettepe University

研究点 (1)

Loading locations...

相似试验