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临床试验/NCT05045963
NCT05045963已完成不适用

Evaluating the Impact of Aminoglycosides in Hypotensive Septic Oncology Patients

M.D. Anderson Cancer Center1 个研究点 分布在 1 个国家目标入组 232 人开始时间: 2021年1月4日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
232
试验地点
1
主要终点
Time to resolution of hypotension

研究概览

简要总结

This study evaluates the impact of aminoglycosides in hypotensive septic oncologic patients. In the oncologic patient population, sepsis is a major health concern due to high mortality rates and healthcare costs. Prior research shows aminoglycosides antibiotics are frequently used to treat sepsis, but their clinical impact in hypotensive oncology patients upon the progression of sepsis is not known.

详细描述

PRIMARY OBJECTIVE:

I. To assess the impact of beta-lactam (BL) + aminoglycoside (AG) combination therapy in hypotensive septic oncology patients.

OUTLINE:

Patients' medical charts are reviewed retrospectively.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients (age >= 18 years) with a diagnosis of sepsis during the index hospital admission identified by International classification of diseases (ICD)-10 codes (as specified below) receiving BL antibiotics within 6 hours prior to or following the onset of hypotension
  • To be included in the AG group, patients must have received at least 1 dose of intravenous (IV) tobramycin or amikacin in addition to the BL therapy within the above time period

排除标准

  • Age < 18 years
  • Receipt of IV AG outside of the above time frame in the AG group or receipt of IV AG within 48 hours prior to or following the onset of hypotension in the BL backbone group
  • Pregnancy
  • Patients not receiving therapy with BL antibiotics

研究组 & 干预措施

Observational (medical record review)

Patients' medical charts are reviewed retrospectively.

干预措施: Electronic Health Record Review (Other)

结局指标

主要结局

Time to resolution of hypotension

时间窗: Within 7 days from hypotension onset

Defined as a mean arterial pressure \> 65 mmHg not requiring vasopressors and sustained for \>= 24 hours.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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