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

Respiratory Insufficiency Clinical Trial

— CAREHEMA  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03399149
• Other study ID #: CARE HEMA (38RC16.238)
• Secondary ID: 2017-A00411-52
• Status: Completed
• Start date: February 13, 2017
• Est. completion date: March 1, 2020

Study information

• Verified date: June 2022
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 221
• Est. completion date: March 1, 2020
• Est. primary completion date: November 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hematologic Malignancy
• Hematologic Neoplasms
• Neoplasms
• Respiratory Insufficiency

Intervention

Other:
• Systematic evaluation by an intensivist
implementation of a standardized procedure for patient care in ICU

Locations

Country	Name	City	State
France	Hematologic unit - Hospital Grenoble Alpes	Grenoble
France	Intensive Care Unit - Hospital Grenoble-Alpes	Grenoble

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

Outcome

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