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Outcomes of Purpura FULminans in Adults - The hOPeFUL Study

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StatusLengkap
Sponsor
Henri Mondor University Hospital
Kolaborator
Fondation de France

Kata kunci

Abstrak

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. 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 limb amputation. The hOPeFUL study aims at assessing the short and long term outcomes of adult patients admitted in the intensive care unit for a purpura fulminans.

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of PF have been well studied in the pediatric setting, the amount of available data for adult PF are scarce, often outdated and mainly limited to patients with meningococcal infections.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

Purpura Fulminans

Intervensi / pengobatan

Other: Phone interview measuring health-related quality of life variables

Tahap

-

Kelompok Lengan

LenganIntervensi / 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 BelajarAll
Metode pengambilan sampelNon-Probability Sample
Menerima Relawan SehatIya
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]

factors associated with hospital mortality (and rate of amputation in the hospital) will be identified using a polytomous logistic regression model

2. Rate of amputation in the hospital; [day 60]

factors associated with rate of amputation in the hospital (and hospital mortality) will be identified using a polytomous logistic regression model

3. Long-term outcome measure: Physical dimension scale of the SF-36 questionnaire [Within 6 years of hospital discharge]

This variable will be compared between patients with purpura fulminans and patients with septic shock non-related to purpura fulminans

Ukuran Hasil Sekunder

1. Mental component score of the SF-36 score [Within 6 years of hospital discharge]

This variable will be compared between patients with purpura fulminans and patients with septic shock non-related to purpura fulminans

2. Activity of daily living (ADL score) [Within 6 years of hospital discharge]

This variable will be compared between patients with purpura fulminans and patients with septic shock non-related to purpura fulminans

3. Hospital anxiety and depression scale [Within 6 years of hospital discharge]

This variable will be compared between patients with purpura fulminans and patients with septic shock non-related to purpura fulminans

4. Impact of Event Scale [Within 6 years of hospital discharge]

This variable will be compared between patients with purpura fulminans and patients with septic shock non-related to purpura fulminans

5. Physical dimension scale of the SF-36 questionnaire [Within 6 years of hospital discharge]

This variable will be compared between patients with purpura fulminans who were and those who were not amputated

6. Mental component score of the SF-36 score [Within 6 years of hospital discharge]

This variable will be compared between patients with purpura fulminans who were and those who were not amputated

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