Nutritional and Metabolic Management of Toxidermia Patients Requiring Intensive Care (TEN Metabolism)

Stevens-Johnson Syndrome Toxic Epidermal Necrolysis Spectrum Clinical Trial

— TEN metabolism  

Official title:

Nutritional and Metabolic Characteristics of Critically Ill Patients Admitted for Severe Toxidermia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05320653
• Other study ID #: CER-2018-2268
• Status: Completed
• Start date: January 1, 2006
• Est. completion date: May 31, 2022

Study information

• Verified date: August 2022
• Source: Centre Hospitalier Universitaire Vaudois
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

Description:

There are yet no description of the metabolic characteristics of patients admitted for Toxic epidermal necrolysis (TEN) or Stevens-Johnson Syndrome (SJS) which are a rare condition, often assimilated to major burns in terms of metabolic requirements. We will conduct a retrospective observational cohort study including all patients admitted for toxidermia (general term including TEN or Lyell syndrome, SJS, and other extensive skin destruction) to the Burn unit of the adult ICU of the Lausanne burn center between 2006 and 2020. The primary outcome will be compliance with the ICU's feeding protocol (feeding route, early start of enteral feeding, ), and secondary outcomes will include the adequacy of energy and protein delivery, and use of indirect calorimetry, and the comparison with both general and burn critically ill patients from prior studies in the ICU. 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, and a stay shorter than 24hours, and major burns. The observation period will be limited to the first 31 days of the ICU stay. The recorded variables will include demographic characteristics, severity scores (SAPSII, SCORe of Toxic Epidermal Necrosis (SCORTEN for SJS/TEN), Nutrition risk screening (NRS) score), body surface area (BSA) affected by the disease, fluid intakes and balance (exudate volume estimation not included) of the first 10 days, body weight during the stay, renal function, length of mechanical ventilation and of ICU stay. Nutritional variables include the route of feeding, the 24hr energy prescription and delivery, protein, glucose, and lipid intakes, propofol, insulin, indirect calorimetry (IC) studies. Laboratory blood results include glucose, prealbumin, albumin, C-reactive protein (CRP), triglycerides, creatinine, and trace elements (Cu, Se, Zn). Descriptive statistics: Wilcoxon rank test, while Chi2 test, changes over time with one-way ANOVA .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: May 31, 2022
• Est. primary completion date: December 31, 2020
• Gender: All
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Stevens-Johnson Syndrome
• Stevens-Johnson Syndrome Toxic Epidermal Necrolysis Spectrum

Intervention

Dietary Supplement:
• Medical nutrition
Nutrition therapy of the critically ill patients

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Vaudois

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compliance with ICU feeding protocol	Proportion of ICU days with covered needs	ICU stay, but maximum 30 days
Secondary	Protein delivery	Delivery of at least 1.1 g/kg day of protein	ICU stay but maximum 30 days
Secondary	Energy delivery	Delivery of at least 25 kcal/kg/day	ICU stay but maximum 30 days