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

2 juli 2026 uppdaterad av: Juergen Grafeneder, Medical University of Vienna

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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Studietyp

Observationell

Inskrivning (Beräknad)

800

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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.

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
The primary outcome of the study is 30-day all-cause mortality in ICU patients.
Tidsram: 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.
From ICU admission to 30 days after ICU admission

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
In-hospital mortality
Tidsram: From hospital admission to hospital discharge evaluated 6 Months after study inclusion
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
Tidsram: 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.
From ICU admission to ICU discharge evaluated 6 Months after study inclusion
Duration of mechanical ventilation
Tidsram: 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.
From initiation of mechanical ventilation to successful discontinuation during ICU stay evaluated 6 Months after study inclusion
Illness severity score
Tidsram: Evaluated from the documentation 6 Months after study inclusion
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
Tidsram: Evaluated from the documentation 6 Months after study inclusion
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
Tidsram: Evaluated from the documentation 6 Months after study inclusion
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
Tidsram: Evaluated from the documentation 6 Months after study inclusion
Severity of illness assessed using SOFA scores, with a higher score signaling higher severity
Evaluated from the documentation 6 Months after study inclusion

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Medical University of Vienna

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

2 juli 2026

Primärt slutförande (Beräknad)

1 juni 2028

Avslutad studie (Beräknad)

1 juli 2028

Studieregistreringsdatum

Först inskickad

27 maj 2026

Först inskickad som uppfyllde QC-kriterierna

2 juni 2026

Första postat (Faktisk)

8 juni 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

6 juli 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

2 juli 2026

Senast verifierad

1 juli 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 1302/2026

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

OBESLUTSAM

IPD-planbeskrivning

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.

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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