Intensive Care Outcome Prediction Using Admission Carbohydrate-deficient Transferrin (IMPACT)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Critical Illness; Alcohol Misuse; Intensive Care (ICU)
• Intervention / Treatment: Diagnostic test: Carbohydrate-Deficient Transferrin (CDT) Measurement

• Study Type: Observational
• Enrollment (Estimated): 800

Contacts and Locations

• Study Contact: Name: Juergen Grafeneder, MD, PhD MSc; Phone Number: ‭+43 1 4040019640‬; Email: juergen.grafeneder@meduniwien.ac.at

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
In-hospital mortality	Death from any cause occurring during the index hospital stay.	From hospital admission to hospital discharge evaluated 6 Months after study inclusion
ICU length of stay	Duration of stay in the intensive care unit, measured in days from ICU admission to ICU discharge.	From ICU admission to ICU discharge evaluated 6 Months after study inclusion
Duration of mechanical ventilation	Total duration of mechanical ventilation during the ICU stay, measured in hours or days.	From initiation of mechanical ventilation to successful discontinuation during ICU stay evaluated 6 Months after study inclusion
Illness severity score	Severity of illness assessed using TISS(-A), with a higher score signaling higher severity	Evaluated from the documentation 6 Months after study inclusion
Illness severity score	Severity of illness assessed using APACHE II , with a higher score signaling higher severity	Evaluated from the documentation 6 Months after study inclusion
Illness severity score	Severity of illness assessed using SAPS II, with a higher score signaling higher severity	Evaluated from the documentation 6 Months after study inclusion
Illness severity score	Severity of illness assessed using SOFA scores, with a higher score signaling higher severity	Evaluated from the documentation 6 Months after study inclusion

Collaborators and Investigators

• Sponsor: Medical University of Vienna

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): July 1, 2028

Study Registration Dates

• First Submitted: May 27, 2026
• First Submitted That Met QC Criteria: June 2, 2026
• First Posted (Actual): June 8, 2026

Study Record Updates

• Last Update Posted (Actual): June 8, 2026
• Last Update Submitted That Met QC Criteria: June 2, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Critical Illness; Intensive Care Units; Alcohol-Related Disorders
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Disease Attributes; Substance-Related Disorders; Chemically-Induced Disorders; Pathological Conditions, Signs and Symptoms; Critical Illness; Alcohol-Related Disorders
• Other Study ID Numbers: 1302/2026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: De-identified individual participant data (IPD) underlying the reported study results, including demographic characteristics, laboratory values, CDT measurements, clinical parameters, and outcome data, may be shared upon reasonable request after publication of the primary results. Data containing directly identifiable personal information will not be shared in order to protect participant privacy and comply with applicable data protection regulations. Requests for access will be evaluated by the study investigators and institutional authorities.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No