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

2. juni 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Observationel

Tilmelding (Anslået)

800

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The primary outcome of the study is 30-day all-cause mortality in ICU patients.
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
In-hospital mortality
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Medical University of Vienna

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juni 2026

Primær færdiggørelse (Anslået)

1. juni 2028

Studieafslutning (Anslået)

1. juli 2028

Datoer for studieregistrering

Først indsendt

27. maj 2026

Først indsendt, der opfyldte QC-kriterier

2. juni 2026

Først opslået (Faktiske)

8. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

8. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 1302/2026

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

IPD-planbeskrivelse

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.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Kritisk sygdom

Kliniske forsøg med Carbohydrate-Deficient Transferrin (CDT) Measurement

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Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

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Betingelser

Sjældne sygdomme

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Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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