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

NCT ID: NCT04928859

Last Updated: 2021-06-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

364 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-06-01

Study Completion Date

2020-07-30

Brief Summary

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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

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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.

Conditions

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Burns Shock

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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the albumin group

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

Albumin

Intervention Type DRUG

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.

the control group

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

No interventions assigned to this group

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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human albumin

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hai-Bin Dai, doctor

Role: STUDY_DIRECTOR

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other Identifiers

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2020-489

Identifier Type: -

Identifier Source: org_study_id

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