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

Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)
Overall Status
Completed
CT.gov ID
NCT04928859
Collaborator
(none)
364
Enrollment
74
Actual Duration (Months)

Study Details

Study Description

Brief Summary

To explore the effects and safety of human albumin in burn shock recovery, and then provide a theoretical basis for its rational use.

Condition or Disease Intervention/Treatment Phase

Detailed Description

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.

Study Design

Study Type:
Observational
Actual Enrollment :
364 participants
Observational Model:
Case-Control
Time Perspective:
Retrospective
Official Title:
Study on Efficacy and Safety of Human Albumin in Burn Shock Recovery
Actual Study Start Date :
Jun 1, 2014
Actual Primary Completion Date :
Jan 1, 2019
Actual Study Completion Date :
Jul 30, 2020

Arms and Interventions

Arm Intervention/Treatment
the albumin group

The albumin group, the patients who used albumin for resuscitation during their hospitalization in the burn ward constituted the albumin group.

Drug: 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.
Other Names:
  • human 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.

    Outcome Measures

    Primary Outcome Measures

    1. the mortality of the patients [during the patients's hospitalization, an average of 1-2 month.]

      The mortality of the patients during their hospitalization.

    Secondary Outcome Measures

    1. the length of the patients's hospital stay [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.

    2. the number of patients that using ventilators [during the patients's hospitalization, an average of 1-2 month.]

      the number of patients who using ventilators during their hospitalization

    3. Volume of fluid used for resuscitationVolume of fluid used for resuscitation the volume of the patients's resuscitation fluid [during the patients's hospitalization, an average of 1-2 month.]

      the volume of the patients's resuscitation fluid using "mL" as the measurement

    4. the number of complications that the patients occurred [during the patients's hospitalization, an average of 1-2 month.]

      the number of complications that the patients occurred during their hospitalization

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Second Affiliated Hospital, School of Medicine, Zhejiang University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Second Affiliated Hospital, School of Medicine, Zhejiang University
    ClinicalTrials.gov Identifier:
    NCT04928859
    Other Study ID Numbers:
    • 2020-489
    First Posted:
    Jun 16, 2021
    Last Update Posted:
    Jun 16, 2021
    Last Verified:
    Jun 1, 2014
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Second Affiliated Hospital, School of Medicine, Zhejiang University
    burns; shock; recovery; human albumin; effect
    Additional relevant MeSH terms:
    Shock
    Burns

    Study Results

    No Results Posted as of Jun 16, 2021