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Clinical Trials/NCT03399149
NCT03399149
Completed
Not Applicable

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

University Hospital, Grenoble2 sites in 1 country221 target enrollmentFebruary 13, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Respiratory Insufficiency
Sponsor
University Hospital, Grenoble
Enrollment
221
Locations
2
Primary Endpoint
delta Sepsis-related Organ Failure Assessment (SOFA) score
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 13, 2017
End Date
March 1, 2020
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University Hospital, Grenoble
Responsible Party
Sponsor

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
  • 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

Outcomes

Primary Outcomes

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

  • renal replacement therapy(up to Day 45)
  • survival status after one year(one year after ICU admission)
  • survival status at the end of the ICU stage(up to Day 45)
  • survival status at the end of the hospitalization(up to Day 120)
  • Invasive mechanical ventilation(up to Day 45)
  • Vasopressive support(up to Day 45)
  • ICU admission(up to 72h)
  • Non-invasive ventilation(up to Day 45)
  • Life quality for patients(up to one year)
  • hematological disease evolution(up to one year)

Study Sites (2)

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