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Epidemiology of Acute Respiratory Distress Syndrome in Chinese ICUs

13. juni 2020 opdateret af: Peking Union Medical College Hospital
The acute respiratory distress syndrome(ARDS)has a high morbidity and mortality in patients admitted to intensive care units(ICUs). It represents a significant public health issue. No large nationwide, multicenters study of ARDS has been conducted in China. The purposes of this study are to analyse: 1)the incidence and outcomes of ARDS in ICU; 2) factors associated the mortality ; and 3) risk factors for development of ARDS .

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

All patients admitted to the participating ICUs during a 6-month period(from January 1, 2015 to July 1,2015 ) will be screened at ICU admission and daily for the occurrence of ARDS ( AECC criteria) for a maximum of 28 days after ICU admission.

Data collection:

  1. For all patients, Demographic characteristics, admission category, the patient source intervention during ICU , APACHEII , SOFA score and discharge information will be collected
  2. For patients with ARDS, data about ABG , parameters of MV, hemodynamic on day0 to day7 and last day of MV will be collected.
  3. For patients without ARDS at ICU admission, data about risk factor for ARDS ,such as LIPS score, parameters of MV , and fluid balance on ICU day0 to day7 will be collected.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

2530

Kontakter og lokationer

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

Studiesteder

  • Kina
    • Beijing
      • Beijing, Beijing, Kina
        • Peking University People's Hospital
      • Beijing, Beijing, Kina, 100730
        • MICU, Peking union medical college hospital
      • Beijing, Beijing, Kina
        • Beijing Hospital of Ministry of Health
      • Beijing, Beijing, Kina
        • Department of Critical Care Medicine, Fuxing Hospital, Capital Medical University
      • Beijing, Beijing, Kina
        • General ICU, Beijing Tongren Hospital, Capital Medical University
      • Beijng, Beijing, Kina
        • China-Japan Friendship Hospital
    • Chongqing
      • ChongQing, Chongqing, Kina
        • Department of Emergency and Intensive Care Medicine, The First Affiliated Hospital of Chongqing Medical University
    • Fujian
      • Fuzhou, Fujian, Kina
        • The First Affiliated Hospital of Fujian Medical University
    • Guangdong
      • Guangzhou, Guangdong, Kina
        • Department of CriticalCare Medicine, Guangdong General Hospital
    • Hainan
      • HaiKou, Hainan, Kina
        • Department of Critical Care Medicine, Hainan Provincial People's Hospital
    • Hebei
      • Shijiazhuang, Hebei, Kina
        • Department of Critical Care Medicine, Hebei Medical University Fourth Hospital
    • Heilongjiang
      • Harbin, Heilongjiang, Kina
        • Department of Critical Care Medicine, The First Affiliated Hospital of Harbin Medical University
    • Henan
      • Zhengzhou, Henan, Kina
        • ICU, The First Affiliated Hospital, Zhengzhou University
    • Hubei
      • WuHan, Hubei, Kina
        • Department of Critical Care Medicine, Tongji Hospital of Tongji Medical College, Huazhong University of Science & Technology
    • Hunan
      • Changsha, Hunan, Kina
        • Department of Critical Care Medicine, Xiangya Hospital, Central South University
    • Inner Mongolia
      • Hohhot, Inner Mongolia, Kina
        • Department of Critical Care Medicine, The Affiliated Hopsital of Inner Mongolia Medical University
    • Jilin
      • ChangChun, Jilin, Kina
        • Department of Critical Care Medicine, The Second Hospital of Jilin University
    • Liaoning
      • Shenyang, Liaoning, Kina
        • Department of Critical Care Medicine, The First Affiliated Hospital of China Medical University
    • Ningxia
      • YinChuan, Ningxia, Kina
        • General Hospital of Ningxia Medical University
    • Shandong
      • Jinan, Shandong, Kina
        • Department of Critical Care Medicine, Qilu Hospital of Shandong University
    • Shanghai
      • Shanghai, Shanghai, Kina
        • Emergency ICU, Ruijin Hospital, Shanghai Jiao Tong University
    • Shanxi
      • XiAn, Shanxi, Kina
        • Surgical Intensive Care Unit, Xijing Hospital
    • Sichuan
      • Chengdu, Sichuan, Kina
        • Department of Critical Care Medicine, West China Hospital, Sichuan University
    • Xinjiang
      • Urumqi, Xinjiang, Kina
        • Department of Critical Care Medicine, First Affiliated Hospital, Xinjiang Medical University
    • Yunnan
      • Kunming, Yunnan, Kina
        • Department of Emergency Medicine and Medical ICU, The First Affiliated Hospital of Kunming Medical University
    • Zhejiang
      • Hangzhou, Zhejiang, Kina
        • Department of Critical Care Medicine, Zhejiang Provincial People's 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

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

All patients admitted to the participating ICUs during a 6-month period(from January 1, 2015 to July 1,2015 )

Beskrivelse

Inclusion Criteria:

all patients age >18 yrs admitted to 24 participating ICUs

Exclusion Criteria:

No patients should be excluded (regardless of age, underlying disease, life expectancy, etc).

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
ARDS, non-ARDS
patients with ARDS and patients without ARDS

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
incidence of acute respiratory distress syndrome (ARDS)
Tidsramme: from ICU admission to 28-day of ICU stay
incidence of ARDS = the number of patients developing ARDS during ICU / the total number of patients admitted to ICU
from ICU admission to 28-day of ICU stay

Sekundære resultatmål

Resultatmål
Tidsramme
ICU mortality of patients with ARDS
Tidsramme: followed up to 3 months after inclusion or to ICU discharge, whichever occurred first
followed up to 3 months after inclusion or to ICU discharge, whichever occurred first
hospital mortality of patients with ARDS
Tidsramme: followed up to 3 months after inclusion or to hospital discharge, whichever occurred first
followed up to 3 months after inclusion or to hospital discharge, whichever occurred first

Samarbejdspartnere og efterforskere

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

Sponsor

Peking Union Medical College Hospital

Efterforskere

  • Ledende efterforsker: Bin Du, MICU of Peking Union Medical College 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 2015

Primær færdiggørelse (Faktiske)

1. august 2015

Studieafslutning (Faktiske)

1. december 2015

Datoer for studieregistrering

Først indsendt

18. maj 2015

Først indsendt, der opfyldte QC-kriterier

1. juli 2015

Først opslået (Skøn)

3. juli 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

16. juni 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

13. juni 2020

Sidst verificeret

1. januar 2015

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • MICU2015_1

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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Betingelser

Sjældne sygdomme

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Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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