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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03399149
Acronym
CAREHEMA
Enrollment
221
Registered
2018-01-16
Start date
2017-02-13
Completion date
2020-03-01
Last updated
2022-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hematologic Malignancy, Respiratory Insufficiency

Keywords

Respiratory Insufficiency, Hematologic Malignancy, Intensive Care Unit

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.

Interventions

OTHERSystematic evaluation by an intensivist

implementation of a standardized procedure for patient care in ICU

Sponsors

University Hospital, Grenoble
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
delta Sepsis-related Organ Failure Assessment (SOFA) scoreup to 72 hoursdifference 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

Secondary

MeasureTime frameDescription
survival status at the end of the ICU stageup to Day 45survival status (alive/dead) at the end of the ICU stage
survival status at the end of the hospitalizationup to Day 120survival status (alive/dead) at the end of the hospitalization
ICU admissionup to 72hDelay between the start of critical care illness and ICU admission Delay is measured in minutes
Invasive mechanical ventilationup to Day 45Number of days with mechanical ventilation
survival status after one yearone year after ICU admissionsurvival status (alive/dead) at one year after ICU admission
Vasopressive supportup to Day 45Number of days with vasopressive support
renal replacement therapyup to Day 45Number of days with renal replacement therapy
hematological disease evolutionup to one yearstatus 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.
Life quality for patientsup to one yearEQ5-D assessment of patients' quality of life one year after Intensive care unit admission
Non-invasive ventilationup to Day 45Number of days with non-invasive ventilation

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026