Outcomes of Purpura FULminans in Adults - The hOPeFUL Study
Kata kunci
Abstrak
Deskripsi
Purpura fulminans (PF) is a rare life-threatening infectious disease characterized by the association of a sudden and extensive purpura together with acute circulatory failure. Neisseria meningitidis and Streptococcus pneumoniae are the most frequently involved microorganisms but other species (e.g., Staphylococcus aureus, Streptococcus pyogenes, Haemophilus influenzae…) have also been reported. Despite prompt antibiotics administration and intensive care management, the mortality of PF has been reported to be as high as 50% in previous adult series. Additionally, patients surviving to the early phase of PF are exposed to a high risk of serious sequelae related to extensive skin necrosis and acral symmetrical gangrene, which typically requires limb amputations, a potential source of severe handicap in these previously young and healthy patients. Although the clinical features and outcomes of PF have been well studied in the pediatric setting, the amount of available data for adult PF are scarce, often outdated and mainly limited to patients with meningococcal infections. The current study aims at assessing the short and long-term outcomes of adult patients admitted in the intensive care unit for a purpura fulminans. A large multicenter retrospective cohort will be built in order to assess hospital outcomes (i.e., mortality and amputations). Long-term outcomes, including health-related quality variables, will be prospectively assessed among survivors and compared to septic controls (i.e., patients having septic shock non-related to purpura fulminans).
tanggal
Terakhir Diverifikasi: | 02/28/2018 |
Pertama Dikirim: | 07/06/2017 |
Perkiraan Pendaftaran Telah Dikirim: | 07/11/2017 |
Pertama Diposting: | 07/12/2017 |
Pembaruan Terakhir Dikirim: | 03/07/2018 |
Pembaruan Terakhir Diposting: | 03/08/2018 |
Tanggal Mulai Studi Sebenarnya: | 07/26/2017 |
Perkiraan Tanggal Penyelesaian Utama: | 03/07/2018 |
Perkiraan Tanggal Penyelesaian Studi: | 03/07/2018 |
Kondisi atau penyakit
Intervensi / pengobatan
Other: Phone interview measuring health-related quality of life variables
Tahap
Kelompok Lengan
Lengan | Intervensi / pengobatan |
---|---|
Exposed to purpura fulminans Patients who were admitted in the intensive care unit and survived a purpura fulminans episode | |
Non-exposed to purpura fulminans Patients admitted in the intensive care unit for a septic shock unrelated to a purpura fulminans, and matched to exposed patients for age, gender, and severity of illness. |
Kriteria kelayakan
Usia yang Layak untuk Belajar | 18 Years Untuk 18 Years |
Jenis Kelamin yang Layak untuk Belajar | All |
Metode pengambilan sampel | Non-Probability Sample |
Menerima Relawan Sehat | Iya |
Kriteria | Inclusion Criteria: - Patients admitted in the intensive care unit between 2010 and 2016 for an infectious purpura fulminans and discharged alive Exclusion Criteria: - Age < 18 years - Non infectious purpura - Infective endocarditis |
Hasil
Ukuran Hasil Utama
1. Hospital mortality [day 60]
2. Rate of amputation in the hospital; [day 60]
3. Long-term outcome measure: Physical dimension scale of the SF-36 questionnaire [Within 6 years of hospital discharge]
Ukuran Hasil Sekunder
1. Mental component score of the SF-36 score [Within 6 years of hospital discharge]
2. Activity of daily living (ADL score) [Within 6 years of hospital discharge]
3. Hospital anxiety and depression scale [Within 6 years of hospital discharge]
4. Impact of Event Scale [Within 6 years of hospital discharge]
5. Physical dimension scale of the SF-36 questionnaire [Within 6 years of hospital discharge]
6. Mental component score of the SF-36 score [Within 6 years of hospital discharge]