跳至主要内容
临床试验/NCT04455113
NCT04455113已完成不适用

Hypophosphatemia Deleteriously Affects Outcome of Septic Shock Patients Admitted to ICU

Ayman Anis Metry1 个研究点 分布在 1 个国家目标入组 317 人开始时间: 2018年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
317
试验地点
1
主要终点
The 28-day ICU mortality rate (28-MR)

研究概览

简要总结

Patients with severe sepsis/septic shock complicated by hypophosphatemia are at high risk of developing morbidities other than that underlying sepsis and more vulnerable to higher mortality rate. Thus, the current study hypothesized that diagnosis and management of hypophosphatemia may be advantageous for reduction of morbidity and mortality rates of septic patients admitted to ICU

详细描述

The current study was started since June 2018 till Jan 2020 after approval of the study protocol by the Local Ethical Committee. The study intended to include all patients admitted to ICU with or developed severe sepsis or septic shock within 24-hr after admission to ICU.

All patients admitted to ICU were eligible to evaluation for demographic and clinical data including hemodynamic data. Disease severity and its impact on body organs were evaluated using acute physiology and chronic health evaluation II score (APACHE II) (20) and SOFA (18) scores. Exclusion criteria included maintenance on immunodepressent therapy for any indication, severe hemorrhagic shock, pregnancy and refusal of nearest relative to sign the written concept for study participation. Children and adulthoods younger than 18 years and patients who were expected to die were also excluded from the study.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All patients admitted to ICU were eligible to evaluation for demographic and clinical data including hemodynamic data.
  • Disease severity and its impact on body organs were evaluated using acute physiology and chronic health evaluation II score (APACHE II) (20) and SOFA (18) scores.

排除标准

  • Maintenance on immunodepressent therapy.
  • Severe hemorrhagic shock.
  • Pregnancy
  • Refusal of nearest relative to sign the written concept for study participation.

结局指标

主要结局

The 28-day ICU mortality rate (28-MR)

时间窗: 28 days

次要结局

  • The correlation between 28-MR and incidence of additional morbidities and severity of HP.(28 days)
  • The incidence of additional morbidities.(30 days)

研究者

发起方
Ayman Anis Metry
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Ayman Anis Metry

Assistant professor

Ain Shams University

研究点 (1)

Loading locations...

相似试验