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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
-
-
-
Grenoble, Frankrike
- Hematologic unit - Hospital Grenoble Alpes
-
Grenoble, Frankrike
- Intensive Care Unit - Hospital Grenoble-Alpes
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: Kohort
- Tidsperspektiv: Blivande
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
"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 |
implementation of a standardized procedure for patient care in ICU
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
delta Sepsis-related Organ Failure Assessment (SOFA) score
Tidsram: 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 |
up to 72 hours
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
survival status after one year
Tidsram: one year after ICU admission
|
survival status (alive/dead) at one year after ICU admission
|
one year after ICU admission
|
|
survival status at the end of the ICU stage
Tidsram: up to Day 45
|
survival status (alive/dead) at the end of the ICU stage
|
up to Day 45
|
|
survival status at the end of the hospitalization
Tidsram: up to Day 120
|
survival status (alive/dead) at the end of the hospitalization
|
up to Day 120
|
|
ICU admission
Tidsram: up to 72h
|
Delay between the start of critical care illness and ICU admission Delay is measured in minutes
|
up to 72h
|
|
Invasive mechanical ventilation
Tidsram: up to Day 45
|
Number of days with mechanical ventilation
|
up to Day 45
|
|
Non-invasive ventilation
Tidsram: up to Day 45
|
Number of days with non-invasive ventilation
|
up to Day 45
|
|
Vasopressive support
Tidsram: up to Day 45
|
Number of days with vasopressive support
|
up to Day 45
|
|
renal replacement therapy
Tidsram: up to Day 45
|
Number of days with renal replacement therapy
|
up to Day 45
|
|
hematological disease evolution
Tidsram: 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.
|
up to one year
|
|
Life quality for patients
Tidsram: up to one year
|
EQ5-D assessment of patients' quality of life one year after Intensive care unit admission
|
up to one year
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Nicolas Terzi, CHU Grenoble Alpes
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- CARE HEMA (38RC16.238)
- 2017-A00411-52 (Annan identifierare: ID RCB)
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
produkt tillverkad i och exporterad från U.S.A.
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .