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Completed

NCT Number: NCT04928859

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.

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Key information

Conditions

Burns Shock Burns Pathologic Processes Pathological Conditions, Signs and Symptoms Shock Wounds and Injuries

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ALBUMIN

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.

Other names: human albumin

Primary outcomes

  1. the mortality of the patients

    Time frame: during the patients's hospitalization, an average of 1-2 month.

    The mortality of the patients during their hospitalization.

Secondary outcomes

  1. the length of the patients's hospital stay

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: during the patients's hospitalization, an average of 1-2 month.

    the number of complications that the patients occurred during their hospitalization

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Important dates

Study start
2014
Primary completion
2019
Study completion
2020
First posted
Jun 16, 2021
Registry last updated
Jun 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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