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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
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-
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Grenoble, Francia
- Hematologic unit - Hospital Grenoble Alpes
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Grenoble, Francia
- Intensive Care Unit - Hospital Grenoble-Alpes
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Modelli osservazionali: Coorte
- Prospettive temporali: Prospettiva
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
|---|---|
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"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
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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delta Sepsis-related Organ Failure Assessment (SOFA) score
Lasso di tempo: up to 72 hours
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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
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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survival status after one year
Lasso di tempo: one year after ICU admission
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survival status (alive/dead) at one year after ICU admission
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one year after ICU admission
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survival status at the end of the ICU stage
Lasso di tempo: up to Day 45
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survival status (alive/dead) at the end of the ICU stage
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up to Day 45
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survival status at the end of the hospitalization
Lasso di tempo: up to Day 120
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survival status (alive/dead) at the end of the hospitalization
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up to Day 120
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ICU admission
Lasso di tempo: up to 72h
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Delay between the start of critical care illness and ICU admission Delay is measured in minutes
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up to 72h
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Invasive mechanical ventilation
Lasso di tempo: up to Day 45
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Number of days with mechanical ventilation
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up to Day 45
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Non-invasive ventilation
Lasso di tempo: up to Day 45
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Number of days with non-invasive ventilation
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up to Day 45
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Vasopressive support
Lasso di tempo: up to Day 45
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Number of days with vasopressive support
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up to Day 45
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renal replacement therapy
Lasso di tempo: up to Day 45
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Number of days with renal replacement therapy
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up to Day 45
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hematological disease evolution
Lasso di tempo: up to one year
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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.
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up to one year
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Life quality for patients
Lasso di tempo: up to one year
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EQ5-D assessment of patients' quality of life one year after Intensive care unit admission
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up to one year
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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Nicolas Terzi, Chu Grenoble Alpes
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- CARE HEMA (38RC16.238)
- 2017-A00411-52 (Altro identificatore: ID RCB)
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