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临床试验/NCT03104933
NCT03104933已完成不适用

Proadrenomedullin and Copeptin as Predictors of Vasopressor Requirements and Volume Resuscitation in Patients With Septic Shock

Spanish Network for Research in Infectious Diseases1 个研究点 分布在 1 个国家目标入组 103 人开始时间: 2016年7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
103
试验地点
1
主要终点
Levels of proADM as predictor of vasopressor requirements

研究概览

简要总结

This study evaluates the usefulness of pro-adrenomedullin (precursor of a vasodilatory peptide involved in septic shock pathogenesis) and copeptin (a stable peptide of the arginine vasopressin precursor) to predict, at the moment of septic shock diagnosis or their changes at 6 hours, the vasopressor requirements (measured by inotropic index and vasopressor dependency ratio) and volume requirement for resuscitation.

详细描述

Physiologically, adrenomedullin has a potent and prolonged vasodilatory effect. In both experimental animals and humans, the intravenous administration of ADM induces a marked and prolonged hypotension. Serum ADM levels are elevated in patients with septic shock. In fact, ADM seems to be one of the main mediators involved in hypotension that these patients present.

ADM is not stable in plasma due to its short half-life and rapid binding to receptors. ADM levels can be measured indirectly by determining proadrenomedullin (proADM) which is a more stable molecule and whose levels are reflected in the plasma of ADM.

Copeptin is released primarily in response to changes in serum osmolarity or blood volume by increasing peripheral vascular resistance and blood pressure.

Copeptin is elevated in patients with shock of different etiologies such as hemorrhagic shock or septic shock.

It is not defined in what situations and at what moment an invasive monitoring of the cardiac output and the different hemodynamic variables that reflect the preload and afterload in patients with septic shock should be performed. In fact, there is great variability in the management and treatment of patients with sepsis and septic shock, which includes the selection of patients who require invasive monitoring and the time of onset.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • Patients ≥ 18 years
  • Diagnosis of septic shock
  • Obtaining written informed consent.

排除标准

  • Initial dose of norepinephrine at ICU admission ≥ 0.6 mg / kg / min.
  • Acute myocardial infarction in the previous month.
  • History of pituitary surgery.
  • Pregnancy.

结局指标

主要结局

Levels of proADM as predictor of vasopressor requirements

时间窗: the first 72 hours.

measured by index inotropic and vasopressor dependency ratio) and fluid requirement

Levels o Copeptin as predictor of vasopressor requirements (measured by index inotropic and vasopressor dependency ratio) and fluid requirement

时间窗: the first 72 hours.

measured by index inotropic and vasopressor dependency ratio) and fluid requirement

次要结局

  • Levels of proADM and Copeptin as predictor of 28-day mortality rate(28 days)
  • Levels of proADM and Copeptin as predictors of lactate clearance(6 hours)
  • Levels of proADM and Copeptin as predictors of organ dysfunction(28 days)

研究者

发起方
Spanish Network for Research in Infectious Diseases
申办方类型
Other
责任方
Sponsor

研究点 (1)

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