AzTrials
AzTrials

Hematologic MalignancyNCT06410066

Outcomes of Critically Ill Patients With Hematologic Malignancies

An observational study of Hematologic Malignancy, run by Soroka University Medical Center.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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%).

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 groups in NCT06410066
Study groupRoleWhat they receive
PATIENTS WITH HEMATOLOGIC MALIGNANCY aADMITTED TO THE ICUall 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.

  1. 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.

  1. First posted10 May 2024
  2. Study start1 Jan 2009
  3. Primary completion31 Dec 2019
  4. Study completion20 Jan 2022

Resources

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
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

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in