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Functional Recovery After Cardiac Surgery : Does Delirium and Calorie Intake Matter?

6. august 2014 opdateret af: National Taiwan University Hospital
The aims of the cohort study is to describe the rates of 30-day surgical complication, functional decline, frailty and one-year mortality for patients experienced cardiac surgery and to delineate the trajectory of functional capacity 1 year after surgery for the patients. It also will test whether the trajectory of functional varied significantly according to delirium status and its type over the follow-up period and examine the patients' postsurgical actual caloric/protein/fluid intake in relation to the functional capacity within 3 months after surgery as well as evaluate whether activity levels, dietary diversity, and depressive symptoms at 3,6, and 12 months affect patient outcome.

Studieoversigt

Status

Ukendt

Betingelser

Detaljeret beskrivelse

In Taiwan, 54.2% of cardiac surgical procedures in 2010 were performed on older patients (≧65 years) with higher rates of surgical complications, functional decline, and even death reported. Despite the large number of older patients undergoing cardiac surgery with the goal of improving functional capacity, the literature in this area is limited. Specifically, there is little information about the functional outcomes 1 year after cardiac surgery for older patients.

A prospective, longitudinal cohort study will be conducted to assess and follow patients aged 65 years and older who undergoing elective or non-elective cardiac surgery for one year after surgery. All patients on the cardio-surgical wards of 5A, 5B, and 5CVI at National Taiwan University Hospital will be screened for eligibility. Every patient ≧65 years admitted for cardiac surgery will be approached and invited to participate. This cohort study aims to 1)describe the rates of 30-day surgical complication, functional decline, frailty, and one-year mortality for older patients underwent cardiac surgery; 2) delineate the rajectory of functional capacity 1 year after surgery for these patients; 3) test whether the trajectory of functional capacity varied significantly according to delirium status and its type over the one-year follow-up period; 4)examine patients' postsurgical actual caloric/protein/fluid intake in relation to the functional capacity within 3 months after surgery; and 5) evaluate hether activity levels, dietary diversity, and depressive symptoms at 3, 6, and 12 months affect patient outcomes. Estimated 236 participants will be enrolled to ensure the power of study.

Data will be analyzed using the SAS package. The Generalized Estimating Equation (GEE) will be performed to identify the risk factors and to delineate the trajectory of functional capacity 1 year after cardiac surgery for older patients. The findings will add to the development of nursing intervention program to promote functional recovery for older patients after cardiac surgery

Undersøgelsestype

Observationel

Tilmelding (Forventet)

300

Kontakter og lokationer

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

Studiesteder

  • Taiwan
      • Taipei, Taiwan
        • Rekruttering
        • National Taiwan University Hospital
        • Kontakt:

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

20 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

patients on the cardio-surgical wards

Beskrivelse

Inclusion Criteria:

  • patients over 20 years old
  • admitted for elective or non-elective cardiac surgery

Exclusion Criteria:

  • incapable of verbal communication
  • sensory impairment
  • intubation or respiratory isolation
  • patients with critical condition or coma

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: Kohorte
  • Tidsperspektiver: Fremadrettet

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
physical activity function
Tidsramme: admission and 1 year after surgery
admission and 1 year after surgery

Sekundære resultatmål

Resultatmål
Tidsramme
mortality
Tidsramme: 1 year after surgery
1 year after surgery

Andre resultatmål

Resultatmål
Tidsramme
30 days surgical complication
Tidsramme: 30 days after surgery
30 days after surgery

Samarbejdspartnere og efterforskere

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

Sponsor

National Taiwan University Hospital

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

1. januar 2013

Primær færdiggørelse (Forventet)

1. december 2017

Studieafslutning (Forventet)

1. december 2017

Datoer for studieregistrering

Først indsendt

6. august 2014

Først indsendt, der opfyldte QC-kriterier

6. august 2014

Først opslået (Skøn)

8. august 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

8. august 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

6. august 2014

Sidst verificeret

1. august 2014

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 201203074RIC

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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