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临床试验/NCT04153578
NCT04153578已完成不适用

Time to Lose the Weight? Comparison of Weight-based and Non-weight-based Vasopressors for Septic Shock

Methodist Health System1 个研究点 分布在 1 个国家目标入组 945 人开始时间: 2019年11月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
945
试验地点
1
主要终点
Efficacy: Total 48-hour vasopressor exposure

研究概览

简要总结

At present, there is conflicting evidence regarding outcomes in patients with septic shock receiving weight-based vasopressor (WBVP) versus non-weight-based vasopressor (NWBVP) dosing strategies. At MCMC, a weight-based strategy is in place whereas MDMC, MMMC and MRMC currently utilize a non-weight-based dosing strategy. Obese patients (BMI > 30) receiving either strategy may potentially be receiving substantially more or less vasopressor exposure compared to their non-obese (BMI < 30) counterparts. Determining total vasopressor exposure and assessing clinical outcomes would benefit our institution and others by providing optimal vasopressor dosing strategies in obese and non-obese patients. There is a difference in clinical outcomes between patients receiving weight-based and non-weight-based vasopressor dosing strategies. There is a difference in total vasopressor exposure between obese and non-obese patients utilizing WBVP and NWBVP strategies.

详细描述

Vasopressors are a mainstay of therapy for patients with septic shock to achieve and maintain hemodynamic stability.1 Both weight-based and non-weight-based dosing recommendations exist with no clear evidence that one is better than the other.3-10 However, in light of the obesity epidemic and emerging evidence regarding the dangers of excessive catecholamine exposure, an evaluation of dosing practices is warranted. The aim of this study is to determine whether clinical outcomes differ between patients receiving weight-based and non-weight-based vasopressor dosing strategies for septic shock. This is a multicenter, retrospective chart review. Patients admitted to MDMC and MCMC from 4/1/2017-8/31/2019 will be identified through the electronic medical record utilizing ICD codes for sepsis and septic shock. Patients meeting study inclusion criteria will be analyzed as described below. Outcomes will be assessed between patients receiving WBVP and NWBVP with planned subgroup analysis in each group between patients with BMI < 30, 30-49, and > 50.

研究设计

研究类型
Observational
观察模型
Case Only
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

  • ICU admission
  • Medical admission type
  • Received NE, epinephrine (EPI), phenylephrine (PE), or dopamine (DA) for septic shock
  • Received NE/EPI/PE/DA for > 24 hours
  • Age ≥ 18 years

排除标准

  • Non-sepsis indication for vasopressors
  • Surgical or trauma admission type
  • ICU length of stay < 24 hours

结局指标

主要结局

Efficacy: Total 48-hour vasopressor exposure

时间窗: 4/1/2017-8/31/2019

Total 48-hour vasopressor exposure (norepinephrine (NE) equivalents, mg)

Safety: Composite of in-hospital mortality, vasopressor-associated adverse events

时间窗: 4/1/2017-8/31/2019

Composite of in-hospital mortality, vasopressor-associated adverse events (arrhythmia, thrombosis)

次要结局

  • Safety: in-hospital mortality, vasopressor-associated adverse events(4/1/2017-8/31/2019)
  • Efficacy: Total number of vasoactive agents required to maintain mean arterial pressure(4/1/2017-8/31/2019)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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