NCT06334042

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
309

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 7, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 12, 2024

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 27, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 8, 2024

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 14, 2024

Completed
8 months until next milestone

Results Posted

Study results publicly available

April 13, 2025

Completed
Last Updated

April 13, 2025

Status Verified

April 1, 2025

Enrollment Period

6 months

First QC Date

March 12, 2024

Results QC Date

December 24, 2024

Last Update Submit

April 10, 2025

Conditions

Keywords

Intensive careMetabolism,glucoseMetabolism,lipid

Outcome Measures

Primary Outcomes (1)

  • 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).

Secondary Outcomes (4)

  • 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).

Study Arms (1)

Intensive Care Patients

Diagnostic Test: Serum Chromium Level

Interventions

Serum Chromium LevelDIAGNOSTIC_TEST

Measuring serum chromium levels from patients who admitted in intensive care unit.

Intensive Care Patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Patient Refusal
  • Taking Chromium Supplement

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University

Ankara, 06230, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes MellitusHyperlipidemiasHypercholesterolemia

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesDyslipidemiasLipid Metabolism Disorders

Results Point of Contact

Title
Oguzhan Kahveci, MD
Organization
Hacettepe University Department of Anesthesiology and Intensive Care

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Anesthesiology Resident, MD

Study Record Dates

First Submitted

March 12, 2024

First Posted

March 27, 2024

Study Start

February 7, 2024

Primary Completion

August 8, 2024

Study Completion

August 14, 2024

Last Updated

April 13, 2025

Results First Posted

April 13, 2025

Record last verified: 2025-04

Locations