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

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

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.

Study Overview

• Status: Completed
• Conditions: Respiratory Insufficiency; Hematologic Malignancy
• Intervention / Treatment: Other: Systematic evaluation by an intensivist

• Study Type: Observational
• Enrollment (Actual): 221

Contacts and Locations

Study Locations

• France
  • Grenoble, France
    • Hematologic unit - Hospital Grenoble Alpes
  • Grenoble, France
    • Intensive Care Unit - Hospital Grenoble-Alpes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

patients with haematological malignacies, presenting acute respiratory and/or hemodynamic failure

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
"Before phase"; 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; 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; implementation of a standardized procedure for patient care in ICU

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble
• Investigators: Principal Investigator: Nicolas Terzi, CHU Grenoble Alpes

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2017
• Primary Completion (Actual): November 1, 2018
• Study Completion (Actual): March 1, 2020

Study Registration Dates

• First Submitted: December 1, 2017
• First Submitted That Met QC Criteria: January 11, 2018
• First Posted (Actual): January 16, 2018

Study Record Updates

• Last Update Posted (Actual): November 7, 2022
• Last Update Submitted That Met QC Criteria: November 2, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Intensive Care Unit; Hematologic Malignancy; Respiratory Insufficiency
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Neoplasms by Site; Hematologic Diseases; Neoplasms; Hematologic Neoplasms; Respiratory Insufficiency
• Other Study ID Numbers: CARE HEMA (38RC16.238); 2017-A00411-52 (Other Identifier: ID RCB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No