An observational study in Necrotizing Soft Tissue Infection, Necrotizing Fasciitis and Gas Gangrene, sponsored by Ole Hyldegaard. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-02-17.
Sponsored by Ole Hyldegaard · Observational
The purpose of this study is to investigate the immune response in patients with necrotizing soft tissue infections (NSTI). The investigation will focus on inflammatory and vasoactive biomarkers as prognostic markers of severity and mortality at admission to Rigshospitalet and the following 3 days
Necrotizing soft tissue infection (NSTI) is a complex, multi-factorial disease with diverse microbiological etiology and varying co-morbidities. The rapidly spreading infection may cause extensive soft tissue damage, limb loss, and multiple organ failure. The incidence of NSTIs has increased over the past years and the fatality rates are still high despite increased focus on these patients (20-30%). The extensive inflammatory response is thought to be a main course of death. However, it is unknown which biomarkers that are responsible for the deleterious effects and how these molecular mediators are modulated during the infection and treatment regimes. Thus, there is a need for novel insight into the immune system disturbances in order to improve outcome of NSTIs.
Location: Copenhagen University Hospital, Rigshospitalet, Denmark.
Design: Observational cohort study.
Cohort: NSTI patients in Denmark.
Controls: 50-100 Patients undergoing elective, orthopedic surgery at Rigshospitalet.
Biomarkers: The investigators will focus on three major groups of biomarkers: Acute-phase proteins, cytokines and vasoactive biomarkers.
Sample size calculations:
Data: Data will be handled according to the National Data Protection Agency. All original records (incl. consent forms and questionnaires) will be archived at trial site for 15 years. The National Data Protection Agency has approved the biobank (2007-58-0015, J. nr. 30-1282).
Ethics: The trial will adhere to the Helsinki Declaration and Danish law. The National Ethics Committee and the Regional Ethics Committee have approved the inclusion of the NSTI patients (CVK-1211709) and the control patients, including biomarker analyses (H-2-2014-071).
Biomarker analyses, data extraction and interpretation will be performed once the recruiting of participants has ended.
28 studies on the registry are indexed under Fasciitis, Necrotizing; 8 are open to participants now.
This study's enrollment of 169 is above the median of 152 across 16 observational studies indexed under Fasciitis, Necrotizing.
Browse Fasciitis, Necrotizing studies →Ole Hyldegaard is the lead sponsor of 6 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
All NSTI patients treated at the University Hospital of Copenhagen, Rigshospitalet
Inclusion Criteria for patients with NSTI:
Exclusion Criteria for patients with NSTI:
Inclusion Criteria for control patients:
Exclusion Criteria for control patients:
Definition: An infection that requires acute hospitalization with intensive care treatment and/or surgery as a consequence of severe soft tissue infection in subcutis, muscle and/or fascia and are spreading along tissue structures.
PTX3, NOx and IL-6 as early markers of disease severity in NSTI patients with and without septic shock
Primary analysis: Association between PTX3-, NOx-, and IL6-concentration and septic shock (PTX3, NOx) or LRINEC ≥ 6 (IL-6) in NSTI patients at time of admission to Rigshospitalet
Time frame: Admission, first 24 hours
Mortality
Time frame: 28, 90, 180 days
Amputation rate
At any anatomical site
Time frame: During ICU admission (expected average of 8 days)
ICU-scoring systems
SAPS II (day 1) APACHE II (day 1) SOFA, GCS excluded (day 1-7), Anaya-score
Time frame: During ICU admission (expected average of 8 days)
Multiple organ failure
Time frame: During ICU admission (expected average of 8 days)
Number of debridements
Time frame: During ICU admission (expected average of 8 days)
Microbial etiology
Tissue and blood samples
Time frame: During ICU admission (expected average of 8 days)
Time from admission to primary hospital until first surgery/debridement
Time frame: 2 days
Ventilator treatment, renal replacement therapy, vasopressor treatment during stay at ICU
Time frame: During ICU admission (expected average of 8 days)
Steroid treatment (injection/oral intake) up to development of NSTI
Time frame: Up to 7 days before surgical diagnose at primary hospital
Inflammatory biomarkers
Secondary analysis: The association between inflammatory biomarkers such as CRP, procalcitonin, mannose-binding-lectin and ficolin-1,2,3, cytokines and septic shock, LRINEC ≥ 6 and SAPS II at admission and the following 3 days
Time frame: Admission and the following 3 days
Vasoactive biomarkers
Secondary analysis: The association between vasoactive biomarkers such as NOx (nitrite, NO2-, and nitrate, NO3-,), L-arginine, asymmetric dimethylarginine, hydrogen sulfide, reactive oxygen species, ICAM-1, E-selectin and septic shock, LRINEC ≥ 6 and SAPS II at admission and the following 3 days
Time frame: Admission and the following 3 days
The effects of immunoglobulin on inflammatory biomarkers
A subgroup analysis will be performed on patients randomized to immunoglobulin or saline as immunoglobulin might affect the biomarker response (PTX3, NO, IL-6). The randomized double-blinded study was initiated April 2014 and registered at ClinicalTrials.gov (NCT02111161).
Time frame: Admission and the following 3 days
Biomarkers and Severity of disease
Subgroup analysis: Systemic inflammatory response syndrome, sepsis, severe sepsis and septic shock will be diagnosed according to standardized criteria (American College of Chest Physicians/Society of Critical Care Medicine Consensus Conference Committee) and the biomarkers will be investigated to see if there is a correlation between disease severity and mortality in these groups.
Time frame: Admission and the following 3 days
Plan to share: No
The record gives a start of Feb 2013, a primary completion of Feb 2016 and a completion of Feb 2016. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Ole Hyldegaard