Clinical trial NCT03399149: Systematic Evaluation by an Intensivist of Hematological Malignancy Patients Presenting With Acute Respiratory or Hemodynamic Failure
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Insufficiency
Hematologic Malignancy
Keywords: Respiratory Insufficiency
Hematologic Malignancy
Intensive Care Unit
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2018-01-16
Enrollment: 221
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with haematological malignacies, presenting acute respiratory and/or hemodynamic failure

Brief summary: 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.


Eligibility criteria: 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

  1. Respiratory : oxygen saturation \<90 % and/or O2 \>3l/min, with either a worsening of saturation or increased oxygen needs within 4h
  2. 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

Primary outcomes:
measure: delta Sepsis-related Organ Failure Assessment (SOFA) score
timeFrame: up to 72 hours
Secondary outcomes:
measure: survival status after one year
timeFrame: one year after ICU admission
measure: survival status at the end of the ICU stage
timeFrame: up to Day 45
measure: survival status at the end of the hospitalization
timeFrame: up to Day 120
measure: ICU admission
timeFrame: up to 72h
measure: Invasive mechanical ventilation
timeFrame: up to Day 45
measure: Non-invasive ventilation
timeFrame: up to Day 45
measure: Vasopressive support
timeFrame: up to Day 45
measure: renal replacement therapy
timeFrame: up to Day 45
measure: hematological disease evolution
timeFrame: up to one year
measure: Life quality for patients
timeFrame: up to one year
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Hematologic unit - Hospital Grenoble Alpes
city: Grenoble
country: France
facility: Intensive Care Unit - Hospital Grenoble-Alpes
Study officials:
affiliation: CHU Grenoble Alpes
name: Nicolas Terzi
role: PRINCIPAL_INVESTIGATOR
References: