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Perioperativ Dexmedetomidin og 30-dages resultater efter voksen hjertekirurgi

9. september 2026 opdateret af: China Medical University Hospital

Perioperativ Dexmedetomidin og 30-dages resultater efter voksen hjertekirurgi: En virkelighedsnær retrospektiv kohortestudie ved hjælp af TriNetX-netværket

Denne observationsundersøgelse anvender de-identificerede elektroniske sundhedsjournaldata fra TriNetX Global Collaborative Network (2010-01-01 til 2025-07-01) for at undersøge, om perioperativ dexmedetomidin (DEX) er associeret med 30-dages resultater efter voksen hjertekirurgi.
Voksne i alderen 18-100 år, der gennemgår første gangs bypass-kirurgi eller hjerteklapkirurgi, er inkluderet.
Eksponering er enhver DEX-administration fra 24 timer før til 48 timer efter indeksoperationen; sammenligningsgrupper modtager ingen DEX i dette vindue.
Det primære resultat er delirium inden for 30 dage.
Sekundære resultater er 30-dages dødelighed af alle årsager, akut nyreskade, lungebetændelse, sepsis, røde blodlegemetransfusion/større blødning, hjerteanfald, iskæmisk slagtilfælde/forbigående iskæmisk anfald, atrieflimren, mekanisk ventilation >96 timer (dag 4-30) og 30-dages genindlæggelse (dag 1-30).
Ingen behandlinger tildeles af forskere, og ingen identificerbar information anvendes.
Resultaterne sigter mod at informere om perioperative sedationsstrategier i rutinemæssig hjertekirurgisk pleje.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Dette er en retrospektiv kohortestudie, der anvender de-identifierede data fra TriNetX Global Collaborative Network (2010-01-01 til 2025-07-01). Voksne i alderen 18-100 år, der gennemgår første gangs koronar bypass-kirurgi eller hjerteklapkirurgi, vil blive identificeret. Perioperativ eksponering defineres som enhver dexmedetomidin-administration fra 24 timer før til 48 timer efter indekskirurgien; sammenligningskohorten består af patienter uden dexmedetomidin i dette vindue. Kliniske udfald inden for 30 dage efter kirurgi inkluderer delirium som primært udfald og en række større postoperative komplikationer og dødelighed. Tendensscore baseret på demografi, komorbiditeter, baseline-medicinering og laboratorieprøver vil blive brugt til at matche eller justere mellem eksponeringsgrupper, med balance vurderet ved hjælp af standardiserede middelforskelle. Tid-til-hændelse-analyser vil anvende Cox proportional hazards-modeller og Kaplan-Meier-kurver, med multiplicitet kontrolleret ved hjælp af Benjamini-Hochberg falsk opdagelsesrate. Alle analyser bruger kun de-identifierede data inden for TriNetX-platformen, uden direkte kontakt med patienter eller adgang til identifikatorer.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

343112

Kontakter og lokationer

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

Studiesteder

  • Taiwan
    • Taichung City
      • Taichung, Taichung City, Taiwan, 40447
        • China Medical University Hospital

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

Voksne i alderen 18-100 år, der gennemgår første CABG- eller klapkirurgi i TriNetX Global Collaborative Network (2010-01-01 til 2025-07-01); anonymiserede EHR-data; eksponering defineret som perioperativ dexmedetomidin -24 til +48 timer; komparator uden dexmedetomidin i det pågældende tidsrum.

Beskrivelse

Inklusionskriterier:

  • Alder 18-100 år.
  • Første gang CABG eller hjerteklapoperation inden for TriNetX i perioden 2010-01-01 til 2025-07-01.
  • ≥90 dages præoperativt observationsdata og et 30-dages postoperativt vindue (død ≤30 dage tæller som komplet).
  • Indexoperation, eksponeringsvindue (-24 til +48 timer) og resultater identificerbare fra standardiserede platformkoder/felter.

Eksklusionskriterier:

  • Terminal nyresygdom eller dialyse inden for 90 dage før indexoperation (ICD-10-CM N18.6, Z49, Z99.2).
  • Ikke første gang CABG/klap i samme indlæggelse.
  • Manglende påkrævede felter eller modstridende poster, der forhindrer unik kasusdefinition.
  • Ikke i stand til at bekræfte eksponeringsvindue eller resultater inden for platformen.

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Dexmedetomidine medication record present
Eligible patients with a qualifying CABG-coded procedure and any RxNorm 48937 dexmedetomidine medication record on the preceding calendar day or the procedure day (days -1 through 0). The same medication-record definition is used in the separately constructed exploratory valve-coded population relative to its own qualifying procedure. Exposure is observed in routine records and is not assigned by investigators. Administration, dose and intraday timing are not confirmed. The CABG-coded and valve-coded populations may overlap and are reported separately.
Medicin: Dexmedetomidine
An observed dexmedetomidine medication record (RxNorm 48937) on the calendar day before or the day of the index procedure. No drug, dose, route or regimen is assigned by the study. This entry describes the record used for exposure classification, not a study intervention.
Andre navne:
  • Precedex
Dexmedetomidine medication record absent
The corresponding eligible CABG-coded or separately constructed valve-coded population with no RxNorm 48937 dexmedetomidine medication record during days -1 through 0 relative to its qualifying index procedure. Dexmedetomidine records outside this window, including later postoperative use, are permitted. Absence of a record does not establish non-administration or identify an alternative sedative regimen. The two procedure populations have separate eligibility and matching and may contain overlapping patients.
Andet: No dexmedetomidine medication record in the specified window
Absence of a dexmedetomidine medication record during days -1 through 0 relative to the index procedure. Other care is not assigned or standardised by the investigators. Dexmedetomidine records outside the specified window are allowed.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
First recorded code-defined delirium or disorientation during days 1-30 after the index procedure
Tidsramme: Day 1 through Day 30 after the index procedure
Time to the first qualifying ICD-10-CM R41.0 or F05 record within the window. R41.0 includes disorientation; this is a code-defined outcome without bedside delirium assessment or individual adjudication. The CABG-coded population is primary and the valve-coded population exploratory. Patients with either code on or before day 0 in all available history are excluded before matching. The outcome-level prior-window exclusion is OFF. Analysis uses the two-sided log-rank test, Kaplan-Meier window-end failure estimates and complementary hazard ratios, subject to the documented censoring and proportionality limitations. The day-1 start is not a verified survival landmark.
Day 1 through Day 30 after the index procedure

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
All-cause mortality during days 0-30 after the index procedure
Tidsramme: Day 0 through Day 30 after the index procedure
Time to a dated death record using the TriNetX Deceased outcome. Death is the event for this endpoint. The data are not assumed to constitute a complete national death registry. Outcome-level prior-window exclusion is OFF. This is one of the eight inferential secondary endpoints in the CABG population.
Day 0 through Day 30 after the index procedure
Code-defined acute kidney injury during days 0-30
Tidsramme: Day 0 through Day 30 after the index procedure
Time to the first qualifying ICD-10-CM N17 record, including applicable descendant codes, within the window. No endpoint-specific exclusion of prior N17 records is applied; this describes a recorded outcome, not necessarily newly occurring disease. Dialysis codes are not treated as acute kidney injury. This replaces the earlier acute-kidney-injury/dialysis composite and is one of the eight inferential secondary endpoints.
Day 0 through Day 30 after the index procedure
Code-defined pneumonia during days 0-30
Tidsramme: Day 0 through Day 30 after the index procedure
Time to the first qualifying record of ICD-10-CM J13, J14, J15, J16, J17 or J18, or ICD-9-CM 483, within the window. No endpoint-specific exclusion of prior pneumonia records is applied. The outcome does not establish microbiological confirmation or newly occurring disease. This is one of the eight inferential secondary endpoints.
Day 0 through Day 30 after the index procedure
Code-defined sepsis during days 0-30
Tidsramme: Day 0 through Day 30 after the index procedure
Time to the first qualifying ICD-10-CM A40 or A41 record within the window. No endpoint-specific exclusion of prior sepsis records is applied. This is a recorded-code outcome, not necessarily newly occurring sepsis, and is one of the eight inferential secondary endpoints.
Day 0 through Day 30 after the index procedure
Blood transfusion, haemorrhage-related diagnosis or thoracic exploration code during days 0-30
Tidsramme: Day 0 through Day 30 after the index procedure
Any qualifying ICD-10-CM I97.410, I97.411, I97.610, I97.611 or D62 record, or SNOMED CT 116863004, 288170000, 301842006, 175190002, 26337002 or 77202008 record, during the analysis window, without endpoint-specific exclusion of prior qualifying records. The retained components include blood transfusion, haemorrhage-related diagnoses and thoracic, pericardial or mediastinal exploration. Exploration codes do not establish bleeding, a postoperative indication or re-operation. This heterogeneous code-defined composite is not major bleeding and does not establish an adjudicated bleeding severity grade. CPT 35820 is not included. This is one of the eight inferential secondary endpoints in the primary CABG comparison.
Day 0 through Day 30 after the index procedure
Code-defined myocardial infarction during days 0-30
Tidsramme: Day 0 through Day 30 after the index procedure
Time to the first qualifying ICD-10-CM I21 or I22 record within the window. No endpoint-specific exclusion of prior myocardial infarction records is applied. This is a recorded-code outcome, not necessarily a new myocardial infarction, and is one of the eight inferential secondary endpoints.
Day 0 through Day 30 after the index procedure
Code-defined ischaemic stroke or transient ischaemic attack during days 0-30
Tidsramme: Day 0 through Day 30 after the index procedure
Time to the first qualifying ICD-10-CM I63 or G45 record within the window. No endpoint-specific exclusion of prior stroke or transient ischaemic attack records is applied. This is a recorded-code outcome, not necessarily newly occurring disease, and is one of the eight inferential secondary endpoints.
Day 0 through Day 30 after the index procedure
Code-defined atrial fibrillation during days 0-30
Tidsramme: Day 0 through Day 30 after the index procedure
Time to the first qualifying ICD-10-CM I48.0, I48.1 or I48.91 record within the window. No endpoint-specific exclusion of prior atrial fibrillation records is applied. The definition is limited to this specified code set and does not establish new-onset atrial fibrillation. This is one of the eight inferential secondary endpoints.
Day 0 through Day 30 after the index procedure
Proportion of patients with respiratory ventilation coded as greater than 96 consecutive hours
Tidsramme: Day 0 through Day 30 after the index procedure
Number and proportion of patients with at least one ICD-10-PCS 5A1955Z record during days 0-30. The code denotes respiratory ventilation greater than 96 consecutive hours, but its recorded date does not establish intubation onset or when 96 hours was reached. This explicitly replaces the previously registered days 4-30 window. Use this outcome batch's analysed denominator; prior-window exclusion is OFF. This is a descriptive recorded-code proportion, not a censoring-adjusted risk. No ventilation Kaplan-Meier or Cox analysis is performed. Comparative statistics generated automatically with the native patient-count output are preserved but are not interpreted as inferential study results or included in multiplicity adjustment.
Day 0 through Day 30 after the index procedure

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Proportion of patients with a recorded inpatient or observation encounter during days 1-30
Tidsramme: Day 1 through Day 30 after the index procedure
Number and proportion of patients with at least one inpatient encounter flag (HL7 v3 Visit Type IMP) or a record under CPT grouping 1013659, Hospital Inpatient and Observation Care Services, within the window. Discharge followed by a new admission is not required, so this replaces the earlier readmission label. Use this measure's own batch denominator; prior-encounter exclusion is OFF. Count patients, not encounter instances. Automatically generated comparative statistics are preserved as technical outputs but are not interpreted as inferential results or included in multiplicity adjustment.
Day 1 through Day 30 after the index procedure
F05-only recorded delirium during days 1-30: sensitivity analysis
Tidsramme: Day 1 through Day 30 after the index procedure
Time to the first qualifying ICD-10-CM F05 record within the window, as an exploratory sensitivity analysis of the primary R41.0-or-F05 definition. Retain the broader exclusion of any R41.0 or F05 record on or before day 0 in all available history, applied before matching. Outcome-level prior-window exclusion is OFF. The CABG sensitivity endpoint was specified and run alongside the revised primary endpoint on 5 September 2026. It is outside the eight-test secondary multiplicity family; its addition to this registry amendment does not imply prospective registration of that run.
Day 1 through Day 30 after the index procedure

Samarbejdspartnere og efterforskere

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

Sponsor

China Medical University Hospital

Efterforskere

  • Ledende efterforsker: En-Bo Wu, MD, Department of Anesthesiology, China Medical University Hospital, Taichung City, Taiwan

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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 (Faktiske)

1. januar 2010

Primær færdiggørelse (Faktiske)

31. juli 2025

Studieafslutning (Faktiske)

31. juli 2025

Datoer for studieregistrering

Først indsendt

17. november 2025

Først indsendt, der opfyldte QC-kriterier

24. november 2025

Først opslået (Faktiske)

25. november 2025

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

11. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CMUH114-REC3-181

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

Denne retrospektive observationsstudie anvender de-identificerede data fra TriNetX Global Collaborative Network. Undersøgere modtager ikke identificerbar information eller genidentifikationsnøgler. Data Use Agreement med TriNetX og deltagende sundhedsorganisationer forbyder deling eller omfordeling af linjeniveau individuelle deltagerdata uden for platformen. Kun aggregerede resultater og modelskøn vil blive delt (f.eks. tabeller, figurer); studiedokumenter og analysekode kan stilles til rådighed ved rimelig anmodning.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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 .

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