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

Completed

• Conditions: Burns Shock
• Interventions: Drug: Albumin

• Registration Number: NCT04928859
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

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.

Study Timeline

• Status Verified: 2014-06
• Study Start: 2014-06-01
• Primary Completion: 2019-01-01
• Study Completion: 2020-07-30
• Study First Submitted: 2021-06-02
• Study First Submitted QC: 2021-06-09
• Last Update Submitted: 2021-06-09
• Study First Posted: 2021-06-16
• Last Update Posted: 2021-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 364

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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
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
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