NCT07632716

Brief Summary

The goal of this observational study is to learn whether hazardous alcohol consumption, measured objectively by carbohydrate-deficient transferrin (CDT) levels at intensive care unit (ICU) admission, is associated with worse outcomes in critically ill patients. The main question it aims to answer is: Do elevated CDT levels at ICU admission predict increased short-term mortality and adverse clinical outcomes in adult non-traumatic ICU patients? Participants admitted to the intensive care unit via the emergency department will have CDT levels measured as part of the study. Researchers will then collect and analyze clinical data, including mortality, duration of mechanical ventilation, delirium, ICU length of stay, renal replacement therapy, and ICU readmission rates, during hospitalization and follow-up.

Trial Health

65
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Trial Health Score

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

Enrollment
800

participants targeted

Target at P75+ for all trials

Timeline
25mo left

Started Jun 2026

Typical duration for all trials

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress2%
Jun 2026Jul 2028

First Submitted

Initial submission to the registry

May 27, 2026

Completed
5 days until next milestone

Study Start

First participant enrolled

June 1, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 8, 2026

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2028

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2028

Last Updated

June 8, 2026

Status Verified

June 1, 2026

Enrollment Period

2 years

First QC Date

May 27, 2026

Last Update Submit

June 2, 2026

Conditions

Keywords

Alcohol-Related DisordersCritical IllnessIntensive Care Units

Outcome Measures

Primary Outcomes (1)

  • The primary outcome of the study is 30-day all-cause mortality in ICU patients.

    30-day all-cause mortality is defined as death from any cause occurring within 30 days after ICU admission. Mortality status will be assessed using patient medical records and, if unavailable, through the Austrian "Zentrales Personenstandsregister" (Central Civil Status Register), which documents registered deaths. Outcomes will be compared between patients with elevated and non-elevated carbohydrate-deficient transferrin (CDT) levels measured at ICU admission.

    From ICU admission to 30 days after ICU admission

Secondary Outcomes (7)

  • In-hospital mortality

    From hospital admission to hospital discharge evaluated 6 Months after study inclusion

  • ICU length of stay

    From ICU admission to ICU discharge evaluated 6 Months after study inclusion

  • Duration of mechanical ventilation

    From initiation of mechanical ventilation to successful discontinuation during ICU stay evaluated 6 Months after study inclusion

  • Illness severity score

    Evaluated from the documentation 6 Months after study inclusion

  • Illness severity score

    Evaluated from the documentation 6 Months after study inclusion

  • +2 more secondary outcomes

Interventions

Carbohydrate-deficient transferrin (CDT) measurement is performed at ICU admission as an objective biomarker of sustained hazardous alcohol consumption during the previous 1-3 weeks. CDT values are obtained from routinely collected blood samples in adult non-traumatic ICU patients admitted via the emergency department. The study is purely observational and does not involve administration of a therapeutic intervention or changes to standard clinical care. CDT levels are analyzed in relation to outcomes including 30-day mortality, ICU length of stay, mechanical ventilation, delirium, renal replacement therapy, and ICU readmission.

Eligibility Criteria

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

Study participants will be selected from adult patients admitted to the Department of Emergency Medicine who are subsequently transferred to an in-house intensive care unit (ICU). The study population consists of critically ill non-traumatic ICU patients receiving routine emergency and intensive care treatment.

You may qualify if:

  • all patients ≥ 18 admitted to the Department of Emergency Medicine and subsequently transferred to an in-house intensive care unit (ICU)

You may not qualify if:

  • Patients transferred to other hospital departments prior to completion of intensive care
  • Patients admitted directly to the ICU without passing the ED
  • Patients admitted to intermediate care units
  • Patients with pre-existing or newly diagnosed hepatic cirrhosis
  • Patients with known or obvious pregnancy will be excluded.
  • Patients with no vascular access

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Critical IllnessAlcohol-Related Disorders

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Central Study Contacts

Juergen Grafeneder, MD, PhD MSc

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 27, 2026

First Posted

June 8, 2026

Study Start

June 1, 2026

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

July 1, 2028

Last Updated

June 8, 2026

Record last verified: 2026-06