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

NCT04928859 | Completed

• 1 other identifier: 2020-489
• Study Type: observational
• Target: 364
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Burns Shock

Keywords

burns; shock; recovery; human albumin; effect

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• the length of the patients's hospital stay

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

• the number of patients that using ventilators

  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

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

• the number of complications that the patients occurred

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

Study Arms (2)

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

the control group

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

Interventions

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.

Also known as: human albumin

the albumin group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• Age ≥ 18
• TBSA≥ 20% （TBSA，the total burn area.）
• Admitted to hospital within 24 hours after injury.

You may not qualify if:

• 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

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

MeSH Terms

Conditions

Burns; Shock

Interventions

Albumins; Serum Albumin, Human

Condition Hierarchy (Ancestors)

Wounds and Injuries; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Proteins; Amino Acids, Peptides, and Proteins; Serum Albumin; Blood Proteins

Study Officials

• Hai-Bin Dai, doctor

  Second Affiliated Hospital, School of Medicine, Zhejiang University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2021
• First Posted: June 16, 2021
• Study Start: June 1, 2014
• Primary Completion: January 1, 2019
• Study Completion: July 30, 2020
• Last Updated: June 16, 2021

Record last verified: 2014-06

Data Sharing

• IPD Sharing: Will not share