Respiratory InsufficiencyCAREHEMANCT03399149
Systematic Evaluation by an Intensivist of Hematological Malignancy Patients Presenting With Acute Respiratory or Hemodynamic Failure
An observational study of Respiratory Insufficiency and Hematologic Malignancy, run by University Hospital, Grenoble at 2 sites in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Insufficiency, Hematologic Malignancy
- What is being tested?
- Systematic evaluation by an intensivist
- How many people
- 221 participants
- Where
- 2 sitesFrance
- Study dates
- 13 Feb 2017to 1 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with haematological malignacies, presenting acute respiratory and/or hemodynamic failure
Who may be able to join
- 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).
Who cannot join
- therapeutic limitations decided hematological investigators (moribund patients, uncontrolled allogenic graft,...)
- Do-not-reanimate directives
- Pregnant or breastfeeding women
Trial locations and contacts
2 sites in 1 country.
France2 sites
Hematologic unit - Hospital Grenoble Alpes
Grenoble
Intensive Care Unit - Hospital Grenoble-Alpes
Grenoble
About this study
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
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
- Being tested
- Systematic evaluation by an intensivist
- Keywords
- Respiratory Insufficiency, Hematologic Malignancy, Intensive Care Unit
- Medical subject headings
- Respiratory Insufficiency, Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Systematic evaluation by an intensivistOther
implementation of a standardized procedure for patient care in ICU
| Study group | Role | What they receive |
|---|---|---|
| "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 Receives: Other: Systematic evaluation by an intensivist |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 72 hours
Secondary outcomes (10)
survival status after one year
survival status (alive/dead) at one year after ICU admission
Measured: 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
Measured: up to Day 45
survival status at the end of the hospitalization
survival status (alive/dead) at the end of the hospitalization
Measured: up to Day 120
ICU admission
Delay between the start of critical care illness and ICU admission Delay is measured in minutes
Measured: up to 72h
Invasive mechanical ventilation
Number of days with mechanical ventilation
Measured: up to Day 45
Non-invasive ventilation
Number of days with non-invasive ventilation
Measured: up to Day 45
Vasopressive support
Number of days with vasopressive support
Measured: up to Day 45
renal replacement therapy
Number of days with renal replacement therapy
Measured: 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.
Measured: up to one year
Life quality for patients
EQ5-D assessment of patients' quality of life one year after Intensive care unit admission
Measured: up to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2018
- Study start13 Feb 2017
- Primary completion1 Nov 2018
- Study completion1 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory InsufficiencyStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 221 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicolas Terzi, Principal investigator, CHU Grenoble Alpes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03399149
- Sponsor's protocol ID
- CARE HEMA (38RC16.238)
- Other IDs
- 2017-A00411-52
- Acronym
- CAREHEMA
- Status last verified
- Jun 2022
- First submitted
- 1 Dec 2017
- Last updated
- 7 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03399149
- Acronym / sponsor ID
- CAREHEMA / CARE HEMA (38RC16.238)
- Conditions
- Respiratory Insufficiency, Hematologic Malignancy
- Keywords
- Respiratory Insufficiency, Hematologic Malignancy, Intensive Care Unit
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 221 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 13 Feb 2017 (actual)
- Primary completion
- 1 Nov 2018 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 16 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| "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 | – | Other: Systematic evaluation by an intensivistCorresponding 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with haematological malignacies, presenting acute respiratory and/or hemodynamic failure
Key inclusion criteria (4 listed)
- Patients hospitalized in a hematology unit
- Patients presenting with criteria for critical respiratory and/or hemodynamic condition and worsening during the next 4 hours
Key exclusion criteria (3 listed)
- therapeutic limitations decided hematological investigators (moribund patients, uncontrolled allogenic graft,...)
- Do-not-reanimate directives
- Pregnant or breastfeeding women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Systematic evaluation by an intensivistimplementation of a standardized procedure for patient care in ICU | Other | "After Phase": Systematic evaluation by an intensivist |
Primary outcome
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
10 secondary outcomes
survival status after one year
Time frame: one year after ICU admission
survival status at the end of the ICU stage
Time frame: up to Day 45
survival status at the end of the hospitalization
Time frame: up to Day 120
ICU admission
Time frame: up to 72h
Invasive mechanical ventilation
Time frame: up to Day 45
Non-invasive ventilation
Time frame: up to Day 45
Vasopressive support
Time frame: up to Day 45
renal replacement therapy
Time frame: up to Day 45
hematological disease evolution
Time frame: up to one year
Life quality for patients
Time frame: up to one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicolas Terzi principal investigator
CHU Grenoble Alpes
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Insufficiency and Hematologic Malignancy, run by University Hospital, Grenoble at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
delta Sepsis-related Organ Failure Assessment (SOFA) score (time frame: up to 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2022.