Intensive Care (ICU)IMPACTNCT07632716
Intensive Care Outcome Prediction Using Admission Carbohydrate-deficient Transferrin
An observational study of Intensive Care (ICU) and Critical Illness, run by Medical University of Vienna at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intensive Care (ICU), Critical Illness, Alcohol Misuse
- What is being tested?
- Carbohydrate-Deficient Transferrin (CDT) Measurement
- How many people
- 800 participants
- Where
- 1 siteAustria
- Study dates
- 2 Jul 2026to Jul 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- all patients ≥ 18 admitted to the Department of Emergency Medicine and subsequently transferred to an in-house intensive care unit (ICU)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site, 1 recruiting
- Recruiting
Medical University of Vienna
Vienna
Juergen Grafeneder; PI, MD PhD Msc, +43 1 40400 19640, juergen.grafeneder@meduniwien.ac.at
About this study
Official title: 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.
- Conditions
- Intensive Care (ICU), Critical Illness, Alcohol Misuse
- Being tested
- Carbohydrate-Deficient Transferrin (CDT) Measurement
- Keywords
- Alcohol-Related Disorders, Critical Illness, Intensive Care Units
- Medical subject headings
- Critical Illness, Alcohol-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carbohydrate-Deficient Transferrin (CDT) MeasurementDiagnostic 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From ICU admission to 30 days after ICU admission
Secondary outcomes (7)
In-hospital mortality
Death from any cause occurring during the index hospital stay.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Evaluated from the documentation 6 Months after study inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2026
- Study start2 Jul 2026
- Primary completionJun 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intensive Care (ICU)Studies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juergen Grafeneder, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07632716
- Sponsor's protocol ID
- 1302/2026
- Acronym
- IMPACT
- Status last verified
- Jul 2026
- First submitted
- 27 May 2026
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IMPACT - Intensive Care Outcome Prediction Using Admission Carbohydrate-deficient Transferrin A Prospective Single-center Cohort Study
- ClinicalTrials.gov ID
- NCT07632716
- Acronym / sponsor ID
- IMPACT / 1302/2026
- Conditions
- Intensive Care (ICU), Critical Illness, Alcohol Misuse
- Keywords
- Alcohol-Related Disorders, Critical Illness, Intensive Care Units
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 2 Jul 2026 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 8 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- all patients ≥ 18 admitted to the Department of Emergency Medicine and subsequently transferred to an in-house intensive care unit (ICU)
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Carbohydrate-Deficient Transferrin (CDT) MeasurementCarbohydrate-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. | Diagnostic test | – |
Primary outcome
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.
7 secondary outcomes
In-hospital mortality
Time frame: From hospital admission to hospital discharge evaluated 6 Months after study inclusion
ICU length of stay
Time frame: From ICU admission to ICU discharge evaluated 6 Months after study inclusion
Duration of mechanical ventilation
Time frame: From initiation of mechanical ventilation to successful discontinuation during ICU stay evaluated 6 Months after study inclusion
Illness severity score
Time frame: Evaluated from the documentation 6 Months after study inclusion
Illness severity score
Time frame: Evaluated from the documentation 6 Months after study inclusion
Illness severity score
Time frame: Evaluated from the documentation 6 Months after study inclusion
Illness severity score
Time frame: Evaluated from the documentation 6 Months after study inclusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Individual participant dataSharing planned: Undecided. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intensive Care (ICU) and Critical Illness, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Juergen Grafeneder, MD, PhD MSc (+43 1 4040019640, juergen.grafeneder@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.