Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05320653 |
| Other study ID # |
CER-2018-2268 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| 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 |
| Health authority |
|
| 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 .
