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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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Grenoble, Frankrig
- Hematologic unit - Hospital Grenoble Alpes
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Grenoble, Frankrig
- Intensive Care Unit - Hospital Grenoble-Alpes
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Kohorte
- Tidsperspektiver: Fremadrettet
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
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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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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delta Sepsis-related Organ Failure Assessment (SOFA) score
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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survival status after one year
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Nicolas Terzi, Chu Grenoble Alpes
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CARE HEMA (38RC16.238)
- 2017-A00411-52 (Anden identifikator: ID RCB)
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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