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

Completed

• Conditions: Hematologic Malignancy; Respiratory Insufficiency
• Interventions: Other: Systematic evaluation by an intensivist

• Registration Number: NCT03399149
• Lead Sponsor: University Hospital, Grenoble

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-02-13
• Study First Submitted: 2017-12-01
• Study First Submitted QC: 2018-01-11
• Study First Posted: 2018-01-16
• Primary Completion: 2018-11-01
• Study Completion: 2020-03-01
• Status Verified: 2022-06
• Last Update Submitted: 2022-11-02
• Last Update Posted: 2022-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 221

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
"After Phase": Systematic evaluation by an intensivist	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

Primary Outcome Measures

Name	Time	Method
delta Sepsis-related Organ Failure Assessment (SOFA) score	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 Outcome Measures

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

Trial Locations

Locations (2)

Hematologic unit - Hospital Grenoble Alpes; 🇫🇷 Grenoble, France

Intensive Care Unit - Hospital Grenoble-Alpes; 🇫🇷 Grenoble, France