Hematologic MalignancyNCT06410066
Outcomes of Critically Ill Patients With Hematologic Malignancies
An observational study of Hematologic Malignancy, run by Soroka University Medical Center.
Trial summary
The investigators sought to report the outcomes of patients with haematological malignancies admitted to the intensive care units and to define pre-intensive care units prognostic factors for in-hospital all-cause mortality. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Hematologic Malignancy
- How many people
- 144 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2009to 20 Jan 2022
- How long will I take part?
- 30 Days
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: all consecutive patients diagnosed with HM and admitted to both ICUs between January 2009 and December 2019.
Who may be able to join
- diagnosis of HM on admission or discharge from the ICU
Who cannot join
- patients under 18 years of age patients who were completely cured of malignancy for more than five years patients admitted to the ICU during the COVID-19 pandemic
About this study
Official title: Outcomes of Non-COVID-19 Critically Ill Patients With Hematologic Malignancies
The investigators sought to report the outcomes of patients with haematological malignancies admitted to the intensive care units and to define pre-intensive care units prognostic factors for in-hospital all-cause mortality.
In this retrospective, single-center study, all patients with haematologic malignancies admitted to intensive care units between 2009 and 2019 were included. The primary outcome was in-hospital mortality.
Read the detailed description
The study was performed at the SUMC, an academic tertiary medical center serving the entire southern district of Israel. Our hospital operates two ICUs: an 8-bed medical ICU and a 16-bed surgical ICU. A senior intensivist and haematologist are available 24 hours every day for clinical decision-making at both units.
The investigators conducted a retrospective cohort study of all consecutive patients diagnosed with HM and admitted to both ICUs between January 2009 and December 2019. The inclusion criteria were a diagnosis of HM on admission or discharge from the ICU. Patients under 18 years of age or who were completely cured of malignancy for more than five years were excluded. Patients admitted to the ICU during the COVID-19 pandemic were also excluded to avoid biases caused by resource accessibility in terms of ICU beds and qualified teams.
The investigators collected data from the hospital's electronic medical records, including demographic data, medical history, and comorbidities, as coded by the International Classification of Diseases (ICD)-9.
Haematological malignancy diagnoses were categorized into five major groups: acute leukemia, aggressive non-Hodgkin lymphoma, Hodgkin lymphoma, multiple myeloma, and others. The remission status, post haematopoietic cell transplantation status (allogeneic or autologous), and date of the last chemotherapy or biological treatment were collected.
Clinical pre-ICU admission parameters, including vital signs, complete blood count, absolute neutrophil counts, lactate dehydrogenase (LDH) levels, liver enzymes, urea and creatinine levels, electrolytes, pH and lactate levels, and coagulation parameters, were recorded at ICU admission. Moreover, the ICU admission Sepsis-Related Organ Failure Assessment (SOFA) score 20 and the acute physiology and chronic health evaluation (APACHE) II severity of disease classification system 21 were recorded, to provide prognostic evidence-based references.
Clinical parameters during ICU admission included treatment with vasopressor medications, the level of respiratory support needed (nasal cannula/reservoir mask/noninvasive ventilation/invasive mechanical ventilation support), the need for renal replacement therapy, and liver dysfunction, defined by the elevation of liver enzymes and bilirubin.
The definition of organ dysfunction during ICU admission included the need for mechanical ventilation, vasopressor treatment, renal replacement therapy, elevated bilirubin >2 mg/dl or newly reduced left ventricular function (defined as an ejection fraction <30%).
- Conditions
- Hematologic Malignancy
- Being tested
- no intervention
- Keywords
- intensive care unit, haematologic malignancy, mortality
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
| Study group | Role | What they receive |
|---|---|---|
| PATIENTS WITH HEMATOLOGIC MALIGNANCY aADMITTED TO THE ICU | all consecutive patients diagnosed with HM and admitted to both ICUs between January 2009 and December 2019. Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality
in hospital mortality
Measured: 30 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2024
- Study start1 Jan 2009
- Primary completion31 Dec 2019
- Study completion20 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematologic MalignancyStudies of the same condition, open and under way.
- 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
- Other
- Enrolment
- 144 participants (actual)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Soroka University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ori Galante, Soroka University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06410066
- Sponsor's protocol ID
- 0038-20-SOR
- Status last verified
- May 2024
- First submitted
- 2 May 2024
- Last updated
- 10 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Non-COVID-19 Critically Ill Patients With Hematologic Malignancies
- ClinicalTrials.gov ID
- NCT06410066
- Acronym / sponsor ID
- 0038-20-SOR
- Conditions
- Hematologic Malignancy
- Keywords
- intensive care unit, haematologic malignancy, mortality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Soroka University Medical CenterUniversity, hospital or other
- Study start
- 1 Jan 2009 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 20 Jan 2022 (actual)
- First posted
- 10 May 2024 (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.
The investigators sought to report the outcomes of patients with haematological malignancies admitted to the intensive care units and to define pre-intensive care units prognostic factors for in-hospital all-cause mortality.
In this retrospective, single-center study, all patients with haematologic malignancies admitted to intensive care units between 2009 and 2019 were included. The primary outcome was in-hospital mortality.
Detailed description
The study was performed at the SUMC, an academic tertiary medical center serving the entire southern district of Israel. Our hospital operates two ICUs: an 8-bed medical ICU and a 16-bed surgical ICU. A senior intensivist and haematologist are available 24 hours every day for clinical decision-making at both units.
The investigators conducted a retrospective cohort study of all consecutive patients diagnosed with HM and admitted to both ICUs between January 2009 and December 2019. The inclusion criteria were a diagnosis of HM on admission or discharge from the ICU. Patients under 18 years of age or who were completely cured of malignancy for more than five years were excluded. Patients admitted to the ICU during the COVID-19 pandemic were also excluded to avoid biases caused by resource accessibility in terms of ICU beds and qualified teams.
The investigators collected data from the hospital's electronic medical records, including demographic data, medical history, and comorbidities, as coded by the International Classification of Diseases (ICD)-9.
Haematological malignancy diagnoses were categorized into five major groups: acute leukemia, aggressive non-Hodgkin lymphoma, Hodgkin lymphoma, multiple myeloma, and others. The remission status, post haematopoietic cell transplantation status (allogeneic or autologous), and date of the last chemotherapy or biological treatment were collected.
Clinical pre-ICU admission parameters, including vital signs, complete blood count, absolute neutrophil counts, lactate dehydrogenase (LDH) levels, liver enzymes, urea and creatinine levels, electrolytes, pH and lactate levels, and coagulation parameters, were recorded at ICU admission. Moreover, the ICU admission Sepsis-Related Organ Failure Assessment (SOFA) score 20 and the acute physiology and chronic health evaluation (APACHE) II severity of disease classification system 21 were recorded, to provide prognostic evidence-based references.
Clinical parameters during ICU admission included treatment with vasopressor medications, the level of respiratory support needed (nasal cannula/reservoir mask/noninvasive ventilation/invasive mechanical ventilation support), the need for renal replacement therapy, and liver dysfunction, defined by the elevation of liver enzymes and bilirubin.
The definition of organ dysfunction during ICU admission included the need for mechanical ventilation, vasopressor treatment, renal replacement therapy, elevated bilirubin >2 mg/dl or newly reduced left ventricular function (defined as an ejection fraction <30%).
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 30 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PATIENTS WITH HEMATOLOGIC MALIGNANCY aADMITTED TO THE ICU | – | Other: no interventionall consecutive patients diagnosed with HM and admitted to both ICUs between January 2009 and December 2019. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- all consecutive patients diagnosed with HM and admitted to both ICUs between January 2009 and December 2019.
Key inclusion criteria (1 listed)
- diagnosis of HM on admission or discharge from the ICU
Key exclusion criteria (1 listed)
- patients under 18 years of age patients who were completely cured of malignancy for more than five years patients admitted to the ICU during the COVID-19 pandemic
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 |
|---|---|---|
| no intervention | Other | PATIENTS WITH HEMATOLOGIC MALIGNANCY aADMITTED TO THE ICU |
Primary outcome
mortality
Time frame: 30 day
in hospital mortality
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 10 May 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Hematologic Malignancy, run by Soroka University Medical Center.
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 1 inclusion and 1 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 10 May 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
mortality (time frame: 30 day). 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 10 May 2024; AzTrials last refreshed its copy on 7 Nov 2026.