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NCT Number: NCT07632716

Intensive Care Outcome Prediction Using Admission Carbohydrate-deficient Transferrin

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.

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Key information

Conditions

Intensive Care (ICU) Alcohol Misuse Alcohol-Related Disorders Chemically-Induced Disorders Critical Illness Disease Attributes Mental Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Carbohydrate-Deficient Transferrin (CDT) Measurement

Diagnostic Test

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.

Primary outcomes

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

    Time frame: From ICU admission to 30 days after ICU admission

    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.

Secondary outcomes

  1. In-hospital mortality

    Time frame: From hospital admission to hospital discharge evaluated 6 Months after study inclusion

    Death from any cause occurring during the index hospital stay.

  2. ICU length of stay

    Time frame: From ICU admission to ICU discharge evaluated 6 Months after study inclusion

    Duration of stay in the intensive care unit, measured in days from ICU admission to ICU discharge.

  3. Duration of mechanical ventilation

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

    Total duration of mechanical ventilation during the ICU stay, measured in hours or days.

  4. Illness severity score

    Time frame: Evaluated from the documentation 6 Months after study inclusion

    Severity of illness assessed using TISS(-A), with a higher score signaling higher severity

  5. Illness severity score

    Time frame: Evaluated from the documentation 6 Months after study inclusion

    Severity of illness assessed using APACHE II , with a higher score signaling higher severity

  6. Illness severity score

    Time frame: Evaluated from the documentation 6 Months after study inclusion

    Severity of illness assessed using SAPS II, with a higher score signaling higher severity

  7. Illness severity score

    Time frame: Evaluated from the documentation 6 Months after study inclusion

    Severity of illness assessed using SOFA scores, with a higher score signaling higher severity

Study contacts

Contact information is provided by the study sponsor or research team.

Juergen Grafeneder, MD, PhD MSc

CONTACT

[email protected]

‭+43 1 4040019640‬

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

IMPACT - Intensive Care Outcome Prediction Using Admission Carbohydrate-deficient Transferrin A Prospective Single-center Cohort Study

Acronym: IMPACT

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jun 8, 2026
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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