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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04480944
Other study ID # CER2018-02268
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2019
Est. completion date March 31, 2020

Study information

Verified date July 2020
Source Centre Hospitalier Universitaire Vaudois
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Burns treatment and management has evolved since the 90s, particularly for massive burns (≥ 50% of total body surface area (TBSA)). This study aims at analyzing the impact of the management changes on the length of intensive care unit (ICU) stay, the take of skin grafts and the mortality.


Description:

Review of all massively burned patients treated at Lausanne University Hospital burn intensive care unit (ca. 40-60 patients). Analysis of changes in length of intensive care unit stay (LICU), skin graft take rate or mortality between 2000 and 2018.

Hypothesis : the optimization of resuscitation procedures and of nutrition therapy combined with the use of novel surgical techniques has brought a significant improvement in outcomes.

Association between outcomes and year of admission will be assessed through correlation analysis and logistic regression analysis. Potential cofounders will be assessed through stepwise linear regression analysis


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date March 31, 2020
Est. primary completion date December 31, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- All adult patients (>18 years old) with burns =50% TBSA admitted in the burn intensive care unit (ICU) of the Lausanne University Hospital

Exclusion Criteria:

- Patients admitted in the burn center ICU with another primary diagnosis than burn (e.g. necrotizing fasciitis, gangrene, toxic epidermal necrolysis)

- Patients referred from and/or to another ICU

- Patients in which active withdrawal of care was decided within 48h of admission

- Patients with first degree burns only

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Switzerland Adult ICU and Burn ICU, Lausanne University Hospital Lausanne Vaud

Sponsors (1)

Lead Sponsor Collaborator
Mette M Berger

Country where clinical trial is conducted

Switzerland, 

References & Publications (2)

Brusselaers N, Hoste EA, Monstrey S, Colpaert KE, De Waele JJ, Vandewoude KH, Blot SI. Outcome and changes over time in survival following severe burns from 1985 to 2004. Intensive Care Med. 2005 Dec;31(12):1648-53. Epub 2005 Oct 12. — View Citation

Pantet O, Stoecklin P, Vernay A, Berger MM. Impact of decreasing energy intakes in major burn patients: A 15-year retrospective cohort study. Clin Nutr. 2017 Jun;36(3):818-824. doi: 10.1016/j.clnu.2016.05.007. Epub 2016 May 24. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary LICU/Percent TBSA Ratio between the length of stay in the ICU and the total body surface area burned 18 years
Secondary Percent TBSA grafted/ Percent TBSA deep burns Ratio between the TBSA grafted and the deep burns TBSA 18 years
Secondary Daily nutritional intakes Daily energy, proteins, lipids and carbohydrates intakes per kilogram of body weight 18 years
Secondary Mortality Percentage of patients who received maximal care and died nonetheless 18 years
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