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

NCT ID: NCT05320653

Last Updated: 2022-08-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 35 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2006-01-01
• Study Completion Date: 2022-05-31

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

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 .

Conditions

Stevens-Johnson Syndrome Toxic Epidermal Necrolysis Spectrum

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Medical nutrition

Nutrition therapy of the critically ill patients

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

enteral, oral and parenteral nutrition

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire Vaudois

OTHER

Sponsor Role: lead

Responsible Party

Mette M Berger

Prof.Hon.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eckert Philippe, MD

Role: STUDY_DIRECTOR

Université de Lausanne, Director of the ICU

References

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.

Reference Type: DERIVED

PMID: 37086614 (View on PubMed)

Other Identifiers

CER-2018-2268

Identifier Type: -

Identifier Source: org_study_id