Treatment in Patients Hospitalized With Acute Exacerbation of Chronic Obstructive Pulmonary Disease (TripAE)
15. august 2014 oppdatert av: Wang Ying, Beijing Chao Yang Hospital
Chronic obstructive pulmonary disease has become a serious global health care and public health problems due to its high prevalence, high morbidity and heavy economic burden.
Acute exacerbation of chronic obstructive pulmonary disease is one of the most important causes of death in patients with COPD.
Systemic corticosteroids therapy is recommended in COPD exacerbations.
In clinical practice for the treatment of acute exacerbation of COPD， antibiotic application is still controversial.
Evidence from current guideline is based on strict criteria from randomized controlled trials, thus the given condition is simplified.
Patients meet the criteria account for the minority in the real world.
Therefore, it is still not clear whether most patients benefit from the recommended treatment.
In our design, hospitalized patients with acute exacerbation of COPD will be enrolled, with their treatment, arterial hypoxemia, recovery time and length of hospitalization being observed.
The main purpose is to evaluate the benefit effect of current recommended treatment of acute exacerbation of COPD in the real world.
Studieoversikt
Status
Ukjent
Forhold
Detaljert beskrivelse
Chronic obstructive pulmonary disease has become a serious global health care and public health problems due to its high prevalence, high morbidity and heavy economic burden.
Acute exacerbation of COPD is one of the most important causes of death in patients with COPD.
The global strategy for the diagnosis, management, and prevention of COPD recommends systemic corticosteroids therapy in COPD exacerbations as it can shorten recovery time, reduce treatment failure, improve lung function and arterial hypoxemia.
In clinical practice for the treatment of acute exacerbation of COPD， antibiotic application is still controversial.
Evidence from current guideline is based on strict criteria from randomized controlled trials, thus the given condition is simplified.
Patients meet the criteria account for the minority in the real world.
Therefore, it is still not clear whether most patients benefit from the recommended treatment.
In our design, hospitalized patients with acute exacerbation of COPD will be enrolled, with their treatment, arterial hypoxemia, recovery time and length of hospitalization being observed.
The main purpose is to evaluate the benefit effect of current recommended treatment of acute exacerbation of COPD in the real world.
Studietype
Observasjonsmessig
Registrering (Forventet)
400
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
40 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
Patients hospitalized with acute exacerbation of chronic obstructive pulmonary disease from 1st July, 2014 from Beijing Chao Yang Hospital
Beskrivelse
Inclusion Criteria:
- Hospitalized patients with acute exacerbation of chronic obstructive pulmonary disease
- Age≥ 40years old
Exclusion Criteria:
- The first diagnosis which caused hospitalization is not acute exacerbation of chronic obstructive pulmonary disease
- Chest radiography shows congestive heart failure
- Chest CT shows lung cancer, active pulmonary tuberculosis, pulmonary thromboembolism or interstitial lung diseases
- Serious cardiac failure, renal insufficiency or hepatic dysfunction
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
change of the score of COPD Assesment Test as a measurement of the overall condition of the patient
Tidsramme: baseline, 1 month after dischahge, 2 months after discharge
|
baseline, 1 month after dischahge, 2 months after discharge
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
change of the score of modified Medical British Research Council questionaire as a measurement of the overall condition of the patient
Tidsramme: baseline, 1 month after discharge, 2 months after discharge
|
baseline, 1 month after discharge, 2 months after discharge
|
Andre resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
percentage of use of systemic corticosteroid in patients
Tidsramme: 8 months after the first enrollment
|
8 months after the first enrollment
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Wang Ying, Master, Beijing Chao Yang Hospital
- Studiestol: Huang Kewu, M.D., Beijing Chao Yang Hospital
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. august 2014
Primær fullføring (Forventet)
1. juni 2015
Studiet fullført (Forventet)
1. september 2015
Datoer for studieregistrering
Først innsendt
9. juli 2014
Først innsendt som oppfylte QC-kriteriene
15. august 2014
Først lagt ut (Anslag)
18. august 2014
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
18. august 2014
Siste oppdatering sendt inn som oppfylte QC-kriteriene
15. august 2014
Sist bekreftet
1. august 2014
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2014-K-115
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