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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04928859
Enrollment
364
Registered
2021-06-16
Start date
2014-06-01
Completion date
2020-07-30
Last updated
2021-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Burns Shock

Keywords

burns; shock; recovery; human albumin; effect

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.

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.

Interventions

DRUGAlbumin

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.

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
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

Design outcomes

Primary

MeasureTime frameDescription
the mortality of the patientsduring the patients's hospitalization, an average of 1-2 month.The mortality of the patients during their hospitalization.

Secondary

MeasureTime frameDescription
the length of the patients's hospital stayduring the patients's hospitalization, an average of 1-2 month.the Length of the patients's hospital stay,an average of 1-2 month.
the number of patients that using ventilatorsduring the patients's hospitalization, an average of 1-2 month.the number of patients who using ventilators during their hospitalization
Volume of fluid used for resuscitationVolume of fluid used for resuscitation the volume of the patients's resuscitation fluidduring the patients's hospitalization, an average of 1-2 month.the volume of the patients's resuscitation fluid using mL as the measurement
the number of complications that the patients occurredduring the patients's hospitalization, an average of 1-2 month.the number of complications that the patients occurred during their hospitalization

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026