Study on Efficacy and Safety of Human Albumin in Burn Shock Recovery
9. juni 2021 oppdatert av: Second Affiliated Hospital, School of Medicine, Zhejiang University
To explore the effects and safety of human albumin in burn shock recovery, and then provide a theoretical basis for its rational use.
Studieoversikt
Detaljert beskrivelse
A retrospective case-control study was conducted.
Patients who admitted to the burn ward and needed fluid resuscitation during the period of January 2011 to December 2018 in our unit were identified.
Patients were divided into two groups according to the severity of burns, the patients with a 20%<TBSA≤50% constituted the moderate and severe burn group, the patients with a TBSA>50% constituted the severest burn group, and then the patients who used albumin for resuscitation constituted the albumin group, the patients who did not use albumin constituted the control group.
The primary outcome was mortality, and the secondary outcomes included hospital stay, ventilator supporting, fluid use, and complications.
Studietype
Observasjonsmessig
Registrering (Faktiske)
364
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
18 år til 60 år (Voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
The patients who admitted to the burn ward of the Second Affiliated Hospital, School of Medicine, Zhejiang University and needed fluid resuscitation were identified during the period of January 2011 to December 2018.
Beskrivelse
Inclusion Criteria:
- Age ≥ 18
- TBSA≥ 20% （TBSA，the total burn area.）
- Admitted to hospital within 24 hours after injury.
Exclusion Criteria:
- STB ≥ 33 μ mol/L
- Cr ≥ 171 μ
- Urine output l< 500 ml / 24 h
- Pregnant and lactating women
- Severe combined injury
- Glucocorticoids users
- Immunosuppressants users
- Patients survived less than 48 hours
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
the albumin group
The albumin group, the patients who used albumin for resuscitation during their hospitalization in the burn ward constituted the albumin group.
|
At least one dose of human albumin was used for the patients during hospitalization in the burn ward consisted the albumin group. The patients who have no albumin use during their hospitalization in the burn ward consisted the control group.
Andre navn:
|
|
the control group
The control group, the patients who did not use albumin during their hospitalization in the burn ward constituted the control group.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
the mortality of the patients
Tidsramme: during the patients's hospitalization, an average of 1-2 month.
|
The mortality of the patients during their hospitalization.
|
during the patients's hospitalization, an average of 1-2 month.
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
the length of the patients's hospital stay
Tidsramme: during the patients's hospitalization, an average of 1-2 month.
|
the Length of the patients's hospital stay,an average of 1-2 month.
|
during the patients's hospitalization, an average of 1-2 month.
|
|
the number of patients that using ventilators
Tidsramme: during the patients's hospitalization, an average of 1-2 month.
|
the number of patients who using ventilators during their hospitalization
|
during the patients's hospitalization, an average of 1-2 month.
|
|
Volume of fluid used for resuscitationVolume of fluid used for resuscitation the volume of the patients's resuscitation fluid
Tidsramme: during the patients's hospitalization, an average of 1-2 month.
|
the volume of the patients's resuscitation fluid using "mL" as the measurement
|
during the patients's hospitalization, an average of 1-2 month.
|
|
the number of complications that the patients occurred
Tidsramme: during the patients's hospitalization, an average of 1-2 month.
|
the number of complications that the patients occurred during their hospitalization
|
during the patients's hospitalization, an average of 1-2 month.
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Studieleder: Hai-Bin Dai, doctor, Second Affiliated Hospital, School of Medicine, Zhejiang University
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 (Faktiske)
1. juni 2014
Primær fullføring (Faktiske)
1. januar 2019
Studiet fullført (Faktiske)
30. juli 2020
Datoer for studieregistrering
Først innsendt
2. juni 2021
Først innsendt som oppfylte QC-kriteriene
9. juni 2021
Først lagt ut (Faktiske)
16. juni 2021
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
16. juni 2021
Siste oppdatering sendt inn som oppfylte QC-kriteriene
9. juni 2021
Sist bekreftet
1. juni 2014
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2020-489
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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