- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT02398890
Follow-up of Oncology Patients After Hospitalization in ICU (SALTO)
"Purpose: The overall prognosis of oncology patients admitted to intensive care has improved greatly in recent years, leading to a wider admission policy. Due to a decrease in mortality in intensive care, more and more patients returning oncological circuit for the continuation of treatment of the underlying disease The existence of sequelae after the ICU (Intensive Care Unit) stay, whether renal, cardiac, respiratory or other, may influence the continuation of the optimal anti -cancer treatments and thus reduce the chances of recovery or evolution without tumor progression. However, no studies have evaluated the effects of resuscitation on subsequent cancer treatment strategies. It would thus become better appreciate the long-term oncology patients discharged alive from the hospital after a stay in intensive care.
Main purpose of research :
Assess the feasibility of a anti-tumor therapy for patients with progressive solid tumors, after an intensive care stay for other reason than elective surgery monitoring or securing an invasive procedure. The possibility of making an anti -cancer treatment will be evaluated by the treating oncologist and classified total, partial or absent from that defined before or during the ICU stay
Secondary objective of the research :
Evaluate the percentage of patients discharged alive from the ICU and dying in the hospital.
Evaluate survival, lifestyle and physical and psychological effects of these patients after discharge from the hospital over a period of one year. It is understood that all these secondary endpoints will interfere with the existence of an evolutionary neoplasia not only with the ICU stay. They will therefore be interpreted with caution.
Study Type: observational Study Design: Prognostic study of routine care, national, prospective, cohort type "
Visão geral do estudo
Descrição detalhada
"Nature of evaluated care: Longitudinal follow-up of post- resuscitation intensive care Concerned population: adult patients with active solid tumor out alive from the ICU and following-up in oncology in the same hospital as the resuscitator investigator.
Main objective: Measure the influence of ICU for patients with solid cancers to continue with optimal anti -cancer treatment, defined before or during hospitalization in intensive care.
Secondary objective: Assess the physical and psychological consequences of ICU stay of patients Evaluation criteria : Primary endpoint: proportion of patients living, out from ICU and hospital, can receive optimal cancer treatment later.
Research Methodology : Prognostic study of routine care, national, prospective, cohort type."
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
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Montfermeil, França, 93370
- CHI Le Raincy-Montfermeil
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
Inclusion criteria:
- Patient with progressive solid tumor hospitalized in intensive care and got out alive
- Oncology patients followed in the same hospital as the investigator resuscitator
- Age ≥ 18 years
- Affiliate of social insurance
- Agree to participate
Exclusion criteria :
- Patient hospitalized for programed surgery
- Hospitalization for securing procedure
- Pregnancy or breastfeeding woman
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
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Proportion of patients with cancer admitted in ICU who will be eligible for optimal anti-cancer treatment after discharge from ICU
Prazo: Months12
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Months12
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Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Outros números de identificação do estudo
- KI120906
- 2013-A00683-42 (Outro identificador: ANSM)
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