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NCT Number: NCT05320653

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

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

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Key information

About this study

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 .

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

medical nutrition

Dietary Supplement

Nutrition therapy of the critically ill patients

Other names: enteral, oral and parenteral nutrition

Primary outcomes

  1. Compliance with ICU feeding protocol

    Time frame: ICU stay, but maximum 30 days

    Proportion of ICU days with covered needs

Secondary outcomes

  1. Protein delivery

    Time frame: ICU stay but maximum 30 days

    Delivery of at least 1.1 g/kg day of protein

  2. Energy delivery

    Time frame: ICU stay but maximum 30 days

    Delivery of at least 25 kcal/kg/day

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Vaudois

Other

Registry information

Official study title

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

Acronym: TEN metabolism

Important dates

Study start
2006
Primary completion
2020
Study completion
2022
First posted
Apr 11, 2022
Registry last updated
Aug 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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