Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Study on Efficacy and Safety of Human Albumin in Burn Shock Recovery

9. juni 2021 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

364

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 til 60 år (Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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

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
Intervention / 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.
Medicin: Albumin

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 navne:
  • humant albumin
the control group
The control group, the patients who did not use albumin during their hospitalization in the burn ward constituted the control group.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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.

Samarbejdspartnere og efterforskere

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

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Efterforskere

  • Studieleder: Hai-Bin Dai, doctor, Second Affiliated Hospital, School of Medicine, Zhejiang University

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 (Faktiske)

1. juni 2014

Primær færdiggørelse (Faktiske)

1. januar 2019

Studieafslutning (Faktiske)

30. juli 2020

Datoer for studieregistrering

Først indsendt

2. juni 2021

Først indsendt, der opfyldte QC-kriterier

9. juni 2021

Først opslået (Faktiske)

16. juni 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

16. juni 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. juni 2021

Sidst verificeret

1. juni 2014

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2020-489

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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 .

Kliniske forsøg med Burns Shock

Kliniske forsøg med Albumin

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Mali

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner