Evaluation of Infective Risk, Efficacy of Bacterial Prophylaxis and Validation of Sepsis Scores NEWS (National Early Warning Score) and qSOFA (Quick Sequential Organ Failure Assessment) in Patient With Acute Myeloid Leukemia Treated With Intensive Chemotherapy (LAM-SEPSIS)

A.O.U. Città della Salute e della Scienza1 site in 1 country400 target enrollmentMarch 23, 2022

ConditionsAcute Myeloid Leukemia

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Acute Myeloid Leukemia
Sponsor: A.O.U. Città della Salute e della Scienza
Enrollment: 400
Locations: 1
Primary Endpoint: Mortality risk
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Evaluation of Infective Risk, Efficacy of Bacterial Prophylaxis and Validation of sepsis scores NEWS (National Early Warning Score) and qSOFA (Quick Sequential Organ Failure Assessment) in Patient With Acute Myeloid Leukemia Treated With Intensive Chemotherapy

Registry

clinicaltrials.gov

Start Date

March 23, 2022

End Date

September 1, 2022

Last Updated

4 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

A.O.U. Città della Salute e della Scienza

Responsible Party

Principal Investigator

Chiara Frairia

Medical Doctor in Hematology

A.O.U. Città della Salute e della Scienza

Eligibility Criteria

Inclusion Criteria

•Diagnosis of non M3 Acute Myeloid Leukemia according to WHO (World Health Organization) 2008 criteria
•Age \>= 18 years and \<= 70 years
•Patient had received intensive chemotherapy either as induction or consolidation regimen
•Period of observation: January 2001 - December 2019
•Written informed consent

Exclusion Criteria

•Diagnosis of Acute Promyelocytic Leukemia (M3 AML)
•Age \< 18 or \>70 years
•Patient had not received intensive chemotherapy

Outcomes

Primary Outcomes

Mortality risk

Time Frame: At baseline (fever onset), change at 24 hours from baseline, change at 48 hours from baseline

Ability of NEWS and qSOFA score to predict mortality risk calculating the area under the ROC (receiver operating characteristics) curve called AUROC (area under the ROC curve)

Secondary Outcomes

Bloodstream infections(From date of fever onset until the date of fever resolution, assessed up to 60 days)
Systemic Inflammatory Response Syndrome (SIRS) development(At baseline (fever onset), change at 24 hours from baseline, change at 48 hours from baseline)
Intensive care unit (ICU) admission(At baseline (fever onset), change at 24 hours from baseline, change at 48 hours from baseline)
Amine requirement(At baseline (fever onset), change at 24 hours from baseline, change at 48 hours from baseline)
Respiratory failure(At baseline (fever onset), change at 24 hours from baseline, change at 48 hours from baseline)
Ventilation support(At baseline (fever onset), change at 24 hours from baseline, change at 48 hours from baseline)
Number of infections(From date of neutrophils count <500/mmc until the day of neutrophils count >=500/mmc, assessed up to 60 days)