NCT05320653

Brief Summary

Retrospective observational cohort study including all patients admitted for toxidermia (Lyell syndrome, Stevens-Johnson Syndrome (SJS), or other extensive skin destruction) to the Burn unit of the adult ICU of the Lausanne burn center between 2006 and 2020. Inclusion criteria: age \>18 years and admission to the burn-ICU for toxidermia whatever body surface affected. Exclusion criteria: to have declined access to the medical record, a stay shorter than 24 hours, and major burns. The observation period will be limited to the first 31 days of the ICU stay. All variables related to nutritional and metabolic management will be recorded

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2006

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
15 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

April 2, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 11, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2022

Completed
Last Updated

August 5, 2022

Status Verified

August 1, 2022

Enrollment Period

15 years

First QC Date

April 2, 2022

Last Update Submit

August 4, 2022

Conditions

Keywords

Critical careMetabolismNutritionProtein

Outcome Measures

Primary Outcomes (1)

  • Compliance with ICU feeding protocol

    Proportion of ICU days with covered needs

    ICU stay, but maximum 30 days

Secondary Outcomes (2)

  • Protein delivery

    ICU stay but maximum 30 days

  • Energy delivery

    ICU stay but maximum 30 days

Interventions

Medical nutritionDIETARY_SUPPLEMENT

Nutrition therapy of the critically ill patients

Also known as: enteral, oral and parenteral nutrition

Eligibility Criteria

Age16 Years+
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Cohort of all patients admitted for SJS/TEN and other toxidermia

You may qualify if:

  • age \>18 years
  • admission to the burn-ICU

You may not qualify if:

  • declined access to the medical record
  • stay shorter than 24hours

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Karakus M, Pantet O, Charriere M, Favre D, Gaide O, Berger MM. Nutritional and metabolic characteristics of critically ill patients admitted for severe toxidermia. Clin Nutr. 2023 Jun;42(6):859-868. doi: 10.1016/j.clnu.2023.04.006. Epub 2023 Apr 8.

MeSH Terms

Conditions

Stevens-Johnson Syndrome

Interventions

Nutrition TherapyParenteral Nutrition

Condition Hierarchy (Ancestors)

StomatitisMouth DiseasesStomatognathic DiseasesDrug EruptionsDermatitisSkin DiseasesSkin and Connective Tissue DiseasesErythema MultiformeErythemaSkin Diseases, VesiculobullousHypersensitivity, DelayedHypersensitivityImmune System DiseasesDrug HypersensitivityDrug-Related Side Effects and Adverse ReactionsChemically-Induced Disorders

Intervention Hierarchy (Ancestors)

TherapeuticsFeeding MethodsNutritional Support

Study Officials

  • Eckert Philippe, MD

    Université de Lausanne, Director of the ICU

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
31 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.Hon.

Study Record Dates

First Submitted

April 2, 2022

First Posted

April 11, 2022

Study Start

January 1, 2006

Primary Completion

December 31, 2020

Study Completion

May 31, 2022

Last Updated

August 5, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share