NCT05249894Unknown不适用
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 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2022年3月23日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Mortality risk
研究概览
简要总结
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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Diagnosis of Acute Promyelocytic Leukemia (M3 AML)
- •Age < 18 or >70 years
- •Patient had not received intensive chemotherapy
结局指标
主要结局
Mortality risk
时间窗: 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)
次要结局
- 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)
研究者
Chiara Frairia
Medical Doctor in Hematology
A.O.U. Città della Salute e della Scienza
研究点 (1)
Loading locations...
相似试验
招募中
不适用
Survey on predictors of infection- and sepsis-related risk- and health-competencyA40.3U07.1J09J10J13Sepsis due to Streptococcus pneumoniaeCOVID-19, virus identifiedInfluenza due to identified zoonotic or pandemic influenza virusInfluenza due to identified seasonal influenza virusPneumonia due to Streptococcus pneumoniaeDRKS00024561Sepsis-Stiftung, Vorstand740
招募中
2 期
Metformin and Lactoferrin in Sepsis in IcuSepsisNCT06181422Tanta University60
尚未招募
不适用
Prospective risk assessment of bacteraemia and other infectious complications in patients undergoing Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA)Incidence of bacteremia following EBUS-TBNA biopsy of mediastinal or hilar massesRespiratory - Other respiratory disorders / diseasesACTRN12609000244202Dr Daniel Steinfort50
已完成
2 期
SEPSIS: L. Plantarum TrialMicrobial ColonizationToleranceSafety IssuesInfant ALLNCT05180201The Hospital for Sick Children519
已完成
不适用
Bacterial Surinfections in COVID-19 ICU PatientsCovid19NCT04877808Jessa Hospital116