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

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

Study Overview

• Status: Completed
• Conditions: Burns Shock
• Intervention / Treatment: Drug: Albumin

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 Type: Observational
• Enrollment (Actual): 364

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the mortality of the patients	The mortality of the patients during their hospitalization.	during the patients's hospitalization, an average of 1-2 month.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the length of the patients's hospital stay	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	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	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	the number of complications that the patients occurred during their hospitalization	during the patients's hospitalization, an average of 1-2 month.

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2014
• Primary Completion (Actual): January 1, 2019
• Study Completion (Actual): July 30, 2020

Study Registration Dates

• First Submitted: June 2, 2021
• First Submitted That Met QC Criteria: June 9, 2021
• First Posted (Actual): June 16, 2021

Study Record Updates

• Last Update Posted (Actual): June 16, 2021
• Last Update Submitted That Met QC Criteria: June 9, 2021
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Keywords: burns; shock; recovery; human albumin; effect
• Additional Relevant MeSH Terms: Pathologic Processes; Wounds and Injuries; Burns; Shock
• Other Study ID Numbers: 2020-489

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No