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

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

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

Study Overview

• Status: Completed
• Conditions: Stevens-Johnson Syndrome Toxic Epidermal Necrolysis Spectrum
• Intervention / Treatment: Dietary supplement: Medical nutrition

Detailed 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 .

• Study Type: Observational
• Enrollment (Actual): 35

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compliance with ICU feeding protocol	Proportion of ICU days with covered needs	ICU stay, but maximum 30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Protein delivery	Delivery of at least 1.1 g/kg day of protein	ICU stay but maximum 30 days
Energy delivery	Delivery of at least 25 kcal/kg/day	ICU stay but maximum 30 days

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Vaudois
• Investigators: Study Director: Eckert Philippe, MD, Université de Lausanne, Director of the ICU

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2006
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): May 31, 2022

Study Registration Dates

• First Submitted: April 2, 2022
• First Submitted That Met QC Criteria: April 2, 2022
• First Posted (Actual): April 11, 2022

Study Record Updates

• Last Update Posted (Actual): August 5, 2022
• Last Update Submitted That Met QC Criteria: August 4, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Nutrition; Critical care; Protein; Metabolism
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Skin Diseases; Immune System Diseases; Stomatognathic Diseases; Mouth Diseases; Hypersensitivity; Erythema; Skin Diseases, Vesiculobullous; Dermatitis; Drug-Related Side Effects and Adverse Reactions; Stomatitis; Drug Eruptions; Erythema Multiforme; Drug Hypersensitivity; Stevens-Johnson Syndrome
• Other Study ID Numbers: CER-2018-2268

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No