- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07571213
Pre-ICU Hospital Length of Stay and 30-day Mortality in the Very Old: a National Cohort of 315 042 ICU Admissions
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
Background. Hospital length of stay before intensive care unit (ICU) admission (pre-ICU LOS) is an established prognostic marker for short-term mortality in critically ill patients: longer pre-ICU stays are generally associated with higher subsequent mortality. Whether this association holds uniformly across the adult age range, or is modified by age, is not established. The question is clinically relevant for the very old (≥80 years), an increasing share of ICU populations, in whom triage decisions are particularly consequential. How age modifies the association between pre-ICU LOS and 30-day mortality will be examined in a national cohort of adult ICU patients.
Design and setting. A retrospective cohort study using prospectively collected data from the Swedish Intensive Care Registry (SIR) linked to the Swedish National Patient Registry (NPR) and the Swedish Cause of Death Registry. The study will include all adult (≥18 years) first ICU admissions reported to SIR between 1 January 2005 and 31 December 2016. Records will be linked across registries via the Swedish personal identification number; patients without a valid number are excluded by the data holders before delivery. The study has been approved by the Regional Ethics Committee of Uppsala (DNR 2016/421), which also waived informed consent.
Exposure. Pre-ICU LOS is the time in hospital between hospital and ICU admission, with zero for direct-from-emergency-department admissions. Where missing, pre-ICU LOS will be reconstructed from NPR care episodes adjacent to the ICU episode.
Outcome. All-cause mortality within 30 days of ICU admission, as a binary endpoint. Follow-up is complete by registry design.
Analysis. The primary analysis will be a binary logistic regression on 30-day mortality, allowing for non-linear effects of age, pre-ICU LOS, and the Quan-updated Charlson comorbidity index, with sex as a binary factor. Pairwise interactions between age and pre-ICU LOS, pre-ICU LOS and sex, and age and sex will be included. The adjustment set is chosen a priori from a directed acyclic graph; acute physiology at admission (SAPS3 Box III) is excluded as a plausible post-exposure mediator. Marginal predicted 30-day mortality and within- and between-age risk differences will be estimated by G-computation at a range of clinically meaningful pre-ICU LOS values across age deciles. Uncertainty will be quantified by nonparametric bootstrap with percentile 95 % confidence intervals. Sensitivity analyses will examine the primary findings under categorical specifications of age and pre-ICU LOS, and after adjustment for SAPS3 Box III with multiple imputation of missing values.
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
-
-
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Uppsala, Sverige
- Uppsala University
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- Patient admitted to a Swedish ICU that reported the admission to the Swedish intensive care registry.
Exclusion Criteria:
-
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
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Patients admitted to Swedish ICUs
Patients admitted to Swedish ICUs between 2005 and 2017
|
Time in hospital before ICU admission by age groups.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Dødelighet
Tidsramme: 30 dager
|
30 dager
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- Age-length of stay
Plan for individuelle deltakerdata (IPD)
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IPD-planbeskrivelse
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