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Completed

NCT Number: NCT03399149

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

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.

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Key information

Conditions

Respiratory Insufficiency Hematologic Diseases Hematologic Malignancy Hematologic Neoplasms Hemic and Lymphatic Diseases Neoplasms Neoplasms by Site Respiration Disorders Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hematologic unit - Hospital Grenoble Alpes, Grenoble, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Systematic evaluation by an intensivist

Other

implementation of a standardized procedure for patient care in ICU

Primary outcomes

  1. delta Sepsis-related Organ Failure Assessment (SOFA) score

    Time frame: up to 72 hours

    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

Secondary outcomes

  1. survival status after one year

    Time frame: one year after ICU admission

    survival status (alive/dead) at one year after ICU admission

  2. survival status at the end of the ICU stage

    Time frame: up to Day 45

    survival status (alive/dead) at the end of the ICU stage

  3. survival status at the end of the hospitalization

    Time frame: up to Day 120

    survival status (alive/dead) at the end of the hospitalization

  4. ICU admission

    Time frame: up to 72h

    Delay between the start of critical care illness and ICU admission Delay is measured in minutes

  5. Invasive mechanical ventilation

    Time frame: up to Day 45

    Number of days with mechanical ventilation

  6. Non-invasive ventilation

    Time frame: up to Day 45

    Number of days with non-invasive ventilation

  7. Vasopressive support

    Time frame: up to Day 45

    Number of days with vasopressive support

  8. renal replacement therapy

    Time frame: up to Day 45

    Number of days with renal replacement therapy

  9. hematological disease evolution

    Time frame: up to one year

    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.

  10. Life quality for patients

    Time frame: up to one year

    EQ5-D assessment of patients' quality of life one year after Intensive care unit admission

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Official study 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

Acronym: CAREHEMA

Important dates

Study start
2017
Primary completion
2018
Study completion
2020
First posted
Jan 16, 2018
Registry last updated
Nov 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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