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临床试验/NCT07565649
NCT07565649已完成不适用

Impact of Systematic Implementation of Point-of-Care Ultrasound on Clinical Course and Survival in Patients With Septic Shock: A Retrospective Single-Center Cohort Study

Clinica Universidad de Navarra, Universidad de Navarra1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2016年1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
200
试验地点
1
主要终点
Change in SOFA score at 48 hours (Delta SOFA)

研究概览

简要总结

This study aims to evaluate the clinical impact of the systematic implementation of point-of-care ultrasound (POCUS) in the management of patients with septic shock in the intensive care unit (ICU).

Septic shock is associated with high morbidity and mortality, and its management requires timely and accurate hemodynamic assessment. Traditional monitoring methods have limitations in evaluating cardiac function, fluid responsiveness, and tissue perfusion. POCUS provides real-time, bedside, non-invasive assessment that may improve clinical decision-making.

This is a retrospective, single-center cohort study comparing two time periods: a pre-implementation cohort (2016-2019) and a post-implementation cohort (2022-2025), excluding the COVID-19 pandemic period. The primary objective is to assess whether the implementation of POCUS is associated with an improvement in early organ dysfunction, measured as the change in SOFA score at 48 hours (delta SOFA). Secondary outcomes include mortality at 28, 60, and 90 days, incidence of acute kidney injury, duration of organ support therapies, and length of ICU and hospital stay.

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

  • Age ≥18 years
  • Admission to the intensive care unit (ICU) with a clinical diagnosis or suspicion of septic shock
  • Microbiological confirmation of infection during clinical course
  • Availability of data required to calculate SOFA score at ICU admission and at 48 hours

排除标准

  • ICU admissions during the period 2020-2021
  • Readmissions related to the same episode of septic shock
  • Missing data required for SOFA score calculation
  • Patients with limitation of life-sustaining therapies

研究组 & 干预措施

Pre-POCUS Cohort

Patients admitted to the ICU with septic shock between January 2016 and December 2019, before the systematic implementation of point-of-care ultrasound (POCUS).

Post-POCUS Cohort

Patients admitted to the ICU with septic shock between January 2022 and December 2025, after the systematic implementation of point-of-care ultrasound (POCUS).

结局指标

主要结局

Change in SOFA score at 48 hours (Delta SOFA)

时间窗: Baseline (ICU admission) and 48 hours after ICU admission

Difference between the Sequential Organ Failure Assessment (SOFA) score at ICU admission and at 48 hours.

次要结局

  • 28-day mortality(Up to 28 days after ICU admission)
  • 60-day mortality(Up to 60 days after ICU admission)
  • 90-day mortality(Up to 90 days after ICU admission)
  • Incidence of acute kidney injury(From ICU admission to ICU discharge)
  • Vasopressor-free days up to day 28(From ICU admission to day 28)
  • Mechanical ventilation-free days up to day 28(From ICU admission to day 28)
  • Renal replacement therapy-free days up to day 28(From ICU admission to day 28)
  • ICU length of stay(From ICU admission to day 28)
  • Hospital length of stay(Through hospital discharge, an average of 28 days)
  • Change in qSOFA score at 24 and 72 hours(Baseline (ICU admission), 24 hours, and 72 hours)

研究者

发起方
Clinica Universidad de Navarra, Universidad de Navarra
申办方类型
Other
责任方
Sponsor

研究点 (1)

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