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Prognosis and Treatment of Necrotizing Soft Tissue Infections: A Prospective Cohort Study (ProTreat)

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ClinicalTrials.gov Identifier: NCT03147352
Recruitment Status : Completed
First Posted : May 10, 2017
Last Update Posted : June 24, 2019
Sponsor:
Collaborator:
Seventh Framework Programme
Information provided by (Responsible Party):
Ole Hyldegaard, Rigshospitalet, Denmark

Brief Summary:
The investigators will analyze biomarkers related to the prognosis and treatment of necrotizing soft tissue infections (NSTI). The focus will be on whether certain endothelial and immune system biomarkers can function as markers of disease severity, mortality as well as the effects of hyperbaric oxygen therapy (HBOT). Biomarkers will be measured upon admission to an intensive care unit at Copenhagen University Hospital and during the following 3 days.

Condition or disease Intervention/treatment
Necrotizing Soft Tissue Infection Necrotizing Fascitis Gas Gangrene Fournier Gangrene Device: Hyperbaric oxygen therapy

  Show Detailed Description

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Study Type : Observational [Patient Registry]
Actual Enrollment : 260 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: ProTreat - Prognosis and Treatment of Necrotizing Soft Tissue Infections: A Prospective Cohort Study
Actual Study Start Date : February 2013
Actual Primary Completion Date : January 2018
Actual Study Completion Date : January 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
NSTI patients
NSTI is 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 that spreads along tissue structures.
Device: Hyperbaric oxygen therapy
Hyperbaric oxygen therapy with 100 % oxygen at 1.8 ATA for 2 hours.

Orthopaedic control patients
Elective orthopaedic control patients.



Primary Outcome Measures :
  1. sTM and sE-selectin as biomarkers of HBOT effect in NSTI patients [ Time Frame: At admission, and during the next 3 days in the ICU ]
    Changes in plasma sTM and sE-selectin concentrations in NSTI patients, compared with the control group

  2. suPAR as a biomarker of disease severity and prognosis in NSTI patients with and without septic shock [ Time Frame: At admission ]
    Association between plasma suPAR levels and NSTI mortality, and SAPS II and SOFA scores


Secondary Outcome Measures :
  1. Mortality [ Time Frame: While in the ICU, and at 28, 90, 180 days ]
    Mortality

  2. Amputation rate [ Time Frame: During ICU admission (expected average of 8 days) ]
    At any anatomical site

  3. ICU scoring systems [ Time Frame: During ICU admission (expected average of 8 days) ]
    SAPS II (day 1) APACHE II (day 1) SOFA, GCS excluded (day 1-7)

  4. Multiple organ failure [ Time Frame: During ICU admission (expected average of 8 days) ]
    Multiple organ failure

  5. Debridements [ Time Frame: During ICU admission (expected average of 8 days) ]
    Number of debridements

  6. Microbial etiology [ Time Frame: During ICU admission (expected average of 8 days) ]
    Tissue and blood samples

  7. Time from admission to primary hospital until first surgery/debridement [ Time Frame: 2 days ]
  8. Ventilator treatment [ Time Frame: During ICU admission (expected average of 8 days) ]
    Ventilator treatment during stay at ICU

  9. Renal replacement therapy [ Time Frame: During ICU admission (expected average of 8 days) ]
    Renal replacement therapy during stay at ICU

  10. Vasopressor treatment [ Time Frame: During ICU admission (expected average of 8 days) ]
    Vasopressor treatment during stay at ICU

  11. Steroid treatment [ Time Frame: Up to 7 days before surgical diagnose at primary hospital ]
    Steroid treatment (injection/oral intake) up to development of NSTI

  12. HBOT and endothelial biomarkers [ Time Frame: At admission, and the next 3 days in the ICU ]
    Any differences in sTM, syndecan-1, sE-selectin, VE-cadherin and protein C levels between NSTI patients who do not receive HBOT within the first 24 hours of ICU admission (because they are deemed too unstable for HBOT) vs. those who receive HBOT within the first 12 and 24 hours of ICU admission

  13. Biomarkers and disease severity [ Time Frame: At admission, and the next 3 days in the ICU ]
    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 suPAR, sTM and sE-selectin will be investigated to see if there is a correlation between disease severity in these groups


Biospecimen Retention:   Samples With DNA
Whole blood and plasma/serum


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

NSTI cohort:

All NSTI patients treated at the University Hospital of Copenhagen, Rigshospitalet.

Orthopaedic control cohort:

Undergoing elective orthopedic surgery (non-pathological fractures, joint replacement surgery or spine surgery) at Copenhagen University Hospital

Criteria

Inclusion criteria for NSTI patients (both of which must be met):

  • Diagnosed with NSTI based on surgical findings (necrosis of any soft tissue compartment; dermis, hypodermis, fascia or muscle)
  • Admitted to the Intensive Care Unit (ICU) and/or operated for NSTI at Copenhagen University Hospital

Exclusion Criteria for NSTI patients:

  • They are categorized as non NSTI in the operating theatre

Inclusion criteria for orthopaedic control patients:

  • Undergoing elective orthopedic surgery (non-pathological fractures, joint replacement surgery or spine surgery) at Copenhagen University Hospital

Exclusion criteria for orthopaedic control patients:

  • Ongoing infection or inflammatory condition

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03147352


Locations
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Denmark
Copenhagen University Hospital, Rigshospitalet
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Ole Hyldegaard
Seventh Framework Programme
Investigators
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Principal Investigator: Peter V Polzik, MD Rigshospitalet, Denmark
Study Director: Ole Hyldegaard, MD, PhD Rigshospitalet, Denmark

Additional Information:

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ole Hyldegaard, Clinical Professor, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT03147352     History of Changes
Other Study ID Numbers: PROTREAT1-PP-2017
First Posted: May 10, 2017    Key Record Dates
Last Update Posted: June 24, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ole Hyldegaard, Rigshospitalet, Denmark:
Fasciitis, Necrotizing
Soft Tissue Infections
Soft Tissue Infections/blood
Bacterial Infections
Infection
Hyperbaric oxygen therapy
Fasciitis
Gangrene
Fournier's Gangrene
Streptococcal septic shock syndrome
Flesh eating bacteria
Meleneys ulcer
Wounds and Injuries
Streptococcus pyogenes
Staphylococcus aureus
Necrosis/blood
Necrosis/diagnosis
Necrosis/mortality
Necrosis/surgery
Prognosis
Risk Factors
Skin Diseases, Bacterial
Observational study
Biological markers
Endothelium
suPAR
sTM
syndecan-1
sE-selectin
VE-cadherin

Additional relevant MeSH terms:
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Infection
Communicable Diseases
Soft Tissue Infections
Fasciitis, Necrotizing
Bacterial Infections
Clostridium Infections
Gram-Positive Bacterial Infections
Fasciitis
Gangrene
Fournier Gangrene
Gas Gangrene
Musculoskeletal Diseases
Necrosis
Pathologic Processes
Skin Diseases, Bacterial
Genital Diseases, Male