Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06410066
Status:
COMPLETED
Last Update Posted:
2024-05-10
First Post:
2024-05-02
Brief Title:
Outcomes of Critically Ill Patients With Hematologic Malignancies
Sponsor:
Soroka University Medical Center
Organization:
Soroka University Medical Center
Study Overview
Official Title:
Outcomes of Non-COVID-19 Critically Ill Patients With Hematologic Malignancies
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 hospitals 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 cannulareservoir masknoninvasive ventilationinvasive 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 mgdl or newly reduced left ventricular function defined as an ejection fraction 30
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 hospitals 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 cannulareservoir masknoninvasive ventilationinvasive 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 mgdl or newly reduced left ventricular function defined as an ejection fraction 30
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None