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

NCT ID: NCT03399149

Last Updated: 2022-11-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 221 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-02-13
• Study Completion Date: 2020-03-01

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.

Conditions

Respiratory Insufficiency; Hematologic Malignancy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

"Before phase"

Retrospective study of ICU admissions of hematology patients for respiratory and hemodynamic reasons Time period: January 2012 to March 2017

No interventions assigned to this group

"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

Systematic evaluation by an intensivist

Intervention Type: OTHER

implementation of a standardized procedure for patient care in ICU

Interventions

Systematic evaluation by an intensivist

implementation of a standardized procedure for patient care in ICU

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Grenoble

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nicolas Terzi

Role: PRINCIPAL_INVESTIGATOR

CHU Grenoble Alpes

Locations

Hematologic unit - Hospital Grenoble Alpes

Grenoble, , France

Intensive Care Unit - Hospital Grenoble-Alpes

Grenoble, , France

Countries

France

Other Identifiers

2017-A00411-52

Identifier Type: OTHER

Identifier Source: secondary_id

CARE HEMA (38RC16.238)

Identifier Type: -

Identifier Source: org_study_id