Systematic Evaluation by an Intensivist of Hematological Malignancy Patients Presenting With Acute Respiratory or Hemodynamic Failure

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Respiratory Insufficiency, Hematologic Malignancy

Intervention / Treatment
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* Other: Systematic evaluation by an intensivist


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Before phase<br>Retrospective study of ICU admissions of hematology patients for respiratory and hemodynamic reasons Time period: January 2012 to March 2017 | |
| After Phase: Systematic evaluation by an intensivist<br>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 | Other: Systematic evaluation by an intensivist<br>* implementation of a standardized procedure for patient care in ICU<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| delta Sepsis-related Organ Failure Assessment (SOFA) score | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| survival status after one year | survival status (alive/dead) at one year after ICU admission | one year after ICU admission | 
| survival status at the end of the ICU stage | survival status (alive/dead) at the end of the ICU stage | up to Day 45 | 
| survival status at the end of the hospitalization | survival status (alive/dead) at the end of the hospitalization | up to Day 120 | 
| ICU admission | Delay between the start of critical care illness and ICU admission Delay is measured in minutes | up to 72h | 
| Invasive mechanical ventilation | Number of days with mechanical ventilation | up to Day 45 | 
| Non-invasive ventilation | Number of days with non-invasive ventilation | up to Day 45 | 
| Vasopressive support | Number of days with vasopressive support | up to Day 45 | 
| renal replacement therapy | Number of days with renal replacement therapy | up to Day 45 | 
| hematological disease evolution | 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 | 
| Life quality for patients | EQ5-D assessment of patients' quality of life one year after Intensive care unit admission | up to one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Respiratory Insufficiency, Hematologic Malignancy, Intensive Care Unit