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- Klinische proef NCT07632716
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.
Studie Overzicht
Toestand
Interventie / Behandeling
Studietype
Inschrijving (Geschat)
Contacten en locaties
Studiecontact
- Naam: Juergen Grafeneder, MD, PhD MSc
- Telefoonnummer: +43 1 4040019640
- E-mail: juergen.grafeneder@meduniwien.ac.at
Studie Locaties
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Vienna, Oostenrijk
- Werving
- Medical University of Vienna
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Contact:
- Juergen Grafeneder; PI, MD PhD Msc
- Telefoonnummer: +43 1 40400 19640
- E-mail: juergen.grafeneder@meduniwien.ac.at
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Bemonsteringsmethode
Studie Bevolking
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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The primary outcome of the study is 30-day all-cause mortality in ICU patients.
Tijdsspanne: From ICU admission to 30 days after ICU admission
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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.
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From ICU admission to 30 days after ICU admission
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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In-hospital mortality
Tijdsspanne: From hospital admission to hospital discharge evaluated 6 Months after study inclusion
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Death from any cause occurring during the index hospital stay.
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From hospital admission to hospital discharge evaluated 6 Months after study inclusion
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ICU length of stay
Tijdsspanne: From ICU admission to ICU discharge evaluated 6 Months after study inclusion
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Duration of stay in the intensive care unit, measured in days from ICU admission to ICU discharge.
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From ICU admission to ICU discharge evaluated 6 Months after study inclusion
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Duration of mechanical ventilation
Tijdsspanne: From initiation of mechanical ventilation to successful discontinuation during ICU stay evaluated 6 Months after study inclusion
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Total duration of mechanical ventilation during the ICU stay, measured in hours or days.
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From initiation of mechanical ventilation to successful discontinuation during ICU stay evaluated 6 Months after study inclusion
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Illness severity score
Tijdsspanne: Evaluated from the documentation 6 Months after study inclusion
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Severity of illness assessed using TISS(-A), with a higher score signaling higher severity
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Evaluated from the documentation 6 Months after study inclusion
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Illness severity score
Tijdsspanne: Evaluated from the documentation 6 Months after study inclusion
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Severity of illness assessed using APACHE II , with a higher score signaling higher severity
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Evaluated from the documentation 6 Months after study inclusion
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Illness severity score
Tijdsspanne: Evaluated from the documentation 6 Months after study inclusion
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Severity of illness assessed using SAPS II, with a higher score signaling higher severity
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Evaluated from the documentation 6 Months after study inclusion
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Illness severity score
Tijdsspanne: Evaluated from the documentation 6 Months after study inclusion
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Severity of illness assessed using SOFA scores, with a higher score signaling higher severity
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Evaluated from the documentation 6 Months after study inclusion
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Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 1302/2026
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
Informatie over medicijnen en apparaten, studiedocumenten
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