Stevens-Johnson Syndrome Toxic Epidermal Necrolysis SpectrumTEN metabolismNCT05320653
Nutritional and Metabolic Management of Toxidermia Patients Requiring Intensive Care (TEN Metabolism)
An observational study of Stevens-Johnson Syndrome Toxic Epidermal Necrolysis Spectrum, run by Centre Hospitalier Universitaire Vaudois.
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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Stevens-Johnson Syndrome Toxic Epidermal Necrolysis Spectrum
- What is being tested?
- Medical nutrition
- Type of treatment
- Pill or oral medicine
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2006to 31 May 2022
- How long will I take part?
- 31 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Child, Adult, Older adult
Study population: Cohort of all patients admitted for SJS/TEN and other toxidermia
Who may be able to join
- age >18 years
- admission to the burn-ICU
Who cannot join
- declined access to the medical record
- stay shorter than 24hours
About this study
Official title: 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
Read the 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 .
- Being tested
- Medical nutrition
- Keywords
- Critical care, Metabolism, Nutrition, Protein
- Medical subject headings
- Stevens-Johnson Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical nutritionDietary supplement
Also called enteral, oral and parenteral nutrition
Nutrition therapy of the critically ill patients
What is being measured
The primary outcome is the main question the study is designed to answer.
Compliance with ICU feeding protocol
Proportion of ICU days with covered needs
Measured: ICU stay, but maximum 30 days
Secondary outcomes (2)
Protein delivery
Delivery of at least 1.1 g/kg day of protein
Measured: ICU stay but maximum 30 days
Energy delivery
Delivery of at least 25 kcal/kg/day
Measured: ICU stay but maximum 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2022
- Study start1 Jan 2006
- Primary completion31 Dec 2020
- Study completion31 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stevens-Johnson Syndrome Toxic Epidermal Necrolysis SpectrumStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire VaudoisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 35 participants (actual)
- Target duration
- 31 Days
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Vaudois
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mette M Berger, Centre Hospitalier Universitaire Vaudois
- Investigators
- Eckert Philippe, MD, Study director, Université de Lausanne, Director of the ICU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05320653
- Sponsor's protocol ID
- CER-2018-2268
- Acronym
- TEN metabolism
- Status last verified
- Aug 2022
- First submitted
- 2 Apr 2022
- Last updated
- 5 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37086614
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional and Metabolic Characteristics of Critically Ill Patients Admitted for Severe Toxidermia
- ClinicalTrials.gov ID
- NCT05320653
- Acronym / sponsor ID
- TEN metabolism / CER-2018-2268
- Keywords
- Critical care, Metabolism, Nutrition, Protein
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire VaudoisUniversity, hospital or other
- Study start
- 1 Jan 2006 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 11 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 31 Days
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Cohort of all patients admitted for SJS/TEN and other toxidermia
Key inclusion criteria (2 listed)
- age >18 years
- admission to the burn-ICU
Key exclusion criteria (2 listed)
- declined access to the medical record
- stay shorter than 24hours
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medical nutritionAlso: enteral, oral and parenteral nutritionNutrition therapy of the critically ill patients | Dietary supplement | – |
Primary outcome
Compliance with ICU feeding protocol
Time frame: ICU stay, but maximum 30 days
Proportion of ICU days with covered needs
2 secondary outcomes
Protein delivery
Time frame: ICU stay but maximum 30 days
Energy delivery
Time frame: ICU stay but maximum 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2022.
- Derived from this study: PubMed 37086614Karakus 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eckert Philippe, MD study director
Université de Lausanne, Director of the ICU
Questions about this trial
What is this clinical trial studying?
An observational study of Stevens-Johnson Syndrome Toxic Epidermal Necrolysis Spectrum, run by Centre Hospitalier Universitaire Vaudois.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compliance with ICU feeding protocol (time frame: ICU stay, but maximum 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05320653, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2022.