Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06410066 |
| Other study ID # |
0038-20-SOR |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2009 |
| Est. completion date |
January 20, 2022 |
Study information
| Verified date |
May 2024 |
| Source |
Soroka University Medical Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical 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.
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.
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%).
