- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01215825
The Doses of Systemic Steroid in Acute Exacerbation of Chronic Obstructive Pulmonary Disease (AECOPD)
The Therapeutic Impact of Various Doses of Systemic Steroid in Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
Data collection from medical charts was conducted at Far Eastern Memorial Hospital, a tertiary-care hospital with around 900 beds. Patients who were admitted from January 2008 to December 2008 and diagnosed as having chronic obstructive pulmonary disease with acute exacerbation (code ICD-9: 491.21) were included in this study. The study was approved by the Institutional Review Board of the Far Eastern Memorial Hospital (FEMH:098097-3).
Demographic data, medical histories and medicine prescriptions at outpatient clinics, emergency and inpatient departments were collected. The initial presentations of acute exacerbation and laboratory data were also summarized from the records of the emergency department. The reports of pulmonary function tests within 6 months before or after the exacerbations were included while reviewing the charts. The probability of concomitant pneumonia (pAECOPD) was determined by attending physicians and reviewed by the investigator according to the radiologic findings. If there were incoherent opinions about the probability of pneumonia between the physicians and the investigator, it was determined by another independent pulmonologist. The highest daily doses and total doses of systemic steroids were calculated and recorded as the equivalent doses of prednisolone (1 mg methylprednisolone is equal to 1.25 mg prednisolone; 1 mg hydrocortisone is equal to 0.25 mg prednisolone). The subjects were divided into 3 groups according to the highest daily dose of steroids as follows: patients receiving more than 60 mg/day were designated to the HD group; those receiving less than or equal to 60 mg/day to the LD group; and those who did not receive any steroids during admission to the NIL group. The length of stay (LOS) was defined as the duration from admission to the emergency department to discharge. Hyperglycemia, psychosis, nosocomial infections and active peptic ulcer diseases were regarded as acute side effects of systemic steroids. Hyperglycemia was defined as a new blood sugar level of more than 200 mg/dl in patients without a history of diabetic mellitus, or an increment in diabetes medications. The relapse rate within 30 days was assessed by outpatient follow-up records.
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
-
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Taipei County
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Ban-chiao City, Taipei County, Taiwan, 220
- Far Eastern Memorial Hospital
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
Inclusion Criteria:
- From January 2008 to December 2008, patients were admitted and diagnosed as having chronic obstructive pulmonary disease with acute exacerbation (code ICD-9: 491.21)
Exclusion Criteria:
-
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
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HD, LD, NIL
HD: the highest daily dose of steroids receiving more than 60 mg/day LD: the highest daily dose of steroids receiving less or equal to 60 mg/day NIL: no steroid use
|
Vad mäter studien?
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
side effects
Tidsram: 2009
|
the side effects of the systemic steroids within groups with different steroid regimens.
|
2009
|
30-day relapse rates
Tidsram: 2009
|
the 30-day relapse rates within groups of various steroid doses
|
2009
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Ping-huai Wang, MD, Far Eastern Memorial Hospital
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 098097-3
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