Systematic Evaluation by an Intensivist of Hematological Malignancy Patients Presenting With Acute Respiratory or Hemodynamic Failure (CAREHEMA)
Systematic Evaluation by an Intensivist of Hematological Malignancy Patients Presenting With Acute Respiratory or Hemodynamic Failure: Impact on Prognosis: A Monocentric Observational Before-after Study
Over the last two decades, the number of patients with hematological malignancies (HMs) admitted to the ICU increased and their mortality has dropped sharply. Patients with HMs increasingly require admission to the intensive care unit (ICU) for life-threatening events related to the malignancy and/or treatments, with immunosuppression being a major contributor. Whether the increase in ICU admissions is related to increased referrals by hematologists and/or to increased admissions by intensivists is unknown. The criteria used for ICU referral and admission decisions have not been extensively evaluated. Finally, the links between admission policies and treatment-limitation decisions are unclear, but ICUs with broad admission policies may change the treatment goals based on the response to several days of full-code management.
The aim of this study is to evaluate the impact of a systematic evaluation by an intensivist of HMs patients presenting with acute respiratory and/or hemodynamic failure.
Visão geral do estudo
Status
Intervenção / Tratamento
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
-
-
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Grenoble, França
- Hematologic unit - Hospital Grenoble Alpes
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Grenoble, França
- Intensive Care Unit - Hospital Grenoble-Alpes
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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:
- Patients hospitalized in a hematology unit
Patients presenting with criteria for critical respiratory and/or hemodynamic condition and worsening during the next 4 hours
- Respiratory : oxygen saturation <90 % and/or O2 >3l/min, with either a worsening of saturation or increased oxygen needs within 4h
- Hemodynamic : systolic blood pressure < 90 mmHg and remaining < 90 mmHg within 4h despite ≥ 1l of crystalloid administration, or becoming < 80 mmHg no matter the quantity of fluid (even if no fluid administration).
Exclusion Criteria:
- therapeutic limitations decided hematological investigators (moribund patients, uncontrolled allogenic graft,...)
- Do-not-reanimate directives
- Pregnant or breastfeeding women
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Modelos de observação: Coorte
- Perspectivas de Tempo: Prospectivo
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
|
"Before phase"
Retrospective study of ICU admissions of hematology patients for respiratory and hemodynamic reasons Time period: January 2012 to March 2017
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"After Phase": Systematic evaluation by an intensivist
Corresponding to the period after the implementation of a systematic intensivist evaluation Daily screening of systolic blood pressure, oxygen saturation and oxygen requirements of all patients hospitalized in hematology wards. Systematic evaluation of any patient presenting the inclusion criteria by an intensivist and collegial care planning. Time period: From March 2017 to end of study |
implementation of a standardized procedure for patient care in ICU
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
delta Sepsis-related Organ Failure Assessment (SOFA) score
Prazo: up to 72 hours
|
difference between the Sepsis-related Organ Failure Assessment score between 48h and 72h after ICU admission and the SOFA score during the first 24h. SOFA score ranges from 0 to 20 delta SOFA= SOFA day 3 - SOFA day1 |
up to 72 hours
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
survival status after one year
Prazo: one year after ICU admission
|
survival status (alive/dead) at one year after ICU admission
|
one year after ICU admission
|
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survival status at the end of the ICU stage
Prazo: up to Day 45
|
survival status (alive/dead) at the end of the ICU stage
|
up to Day 45
|
|
survival status at the end of the hospitalization
Prazo: up to Day 120
|
survival status (alive/dead) at the end of the hospitalization
|
up to Day 120
|
|
ICU admission
Prazo: up to 72h
|
Delay between the start of critical care illness and ICU admission Delay is measured in minutes
|
up to 72h
|
|
Invasive mechanical ventilation
Prazo: up to Day 45
|
Number of days with mechanical ventilation
|
up to Day 45
|
|
Non-invasive ventilation
Prazo: up to Day 45
|
Number of days with non-invasive ventilation
|
up to Day 45
|
|
Vasopressive support
Prazo: up to Day 45
|
Number of days with vasopressive support
|
up to Day 45
|
|
renal replacement therapy
Prazo: up to Day 45
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Number of days with renal replacement therapy
|
up to Day 45
|
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hematological disease evolution
Prazo: up to one year
|
status of hematological primary disease at death or after one year of evolution if the patient is still alive.
Possible status of hematology disease : complete remission, partial remission, stability, relapsed/refractory.
|
up to one year
|
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Life quality for patients
Prazo: up to one year
|
EQ5-D assessment of patients' quality of life one year after Intensive care unit admission
|
up to one year
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Nicolas Terzi, Chu Grenoble Alpes
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 (Real)
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
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- CARE HEMA (38RC16.238)
- 2017-A00411-52 (Outro identificador: ID RCB)
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