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临床试验/NCT05271032
NCT05271032
已完成
不适用

TRANSPULMONARY TERMODILUTION HEMODYNAMIC PROFILE IN PATIENTS WITH SEPTIC SHOCK AFTER INITIAL RESUSCITATION

University of Bari1 个研究点 分布在 1 个国家目标入组 43 人2018年3月1日
适应症Septic Shock

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Septic Shock
发起方
University of Bari
入组人数
43
试验地点
1
主要终点
change in Cardiac function index
状态
已完成
最后更新
2年前

概览

简要总结

Sepsis is the result of a complex pathological process which involves an intravascular inflammatory state, loss of vascular tone, endothelial injury, extravascular leakage, and often inefficient myocardial contractility. These affect the cardiovascular homeostasis as well as the regional perfusion and tissue oxygenation of patient. The importance of early cardiovascular support in septic patients is the reason why, for about fifteen years, the implementation of standardized resuscitation protocols has been emphasized.

The Surviving Sepsis Campaign Guidelines (SSG) recommend an initial fluid resuscitation followed by use of a vasoactive agent such as norepinephrine for the treatment of patients with septic shock. To understand the impact of the hemodynamic support provided by the resuscitation strategy, the assessment of surrogate clinical parameters is pivotal. According to the current guidelines, the increase of mean arterial pressure (MAP) above 65 mmHg represents the threshold in defining patients as "stable".

Although this strategy has been well established, its impact on the actual hemodynamic profile of the septic patient, remains a subject of ongoing controversy. In this scenario, the transpulmonary thermodilution technique (TPTD) allows invasive assessment of the patient hemodynamic profile in terms of fluid responsiveness, vasomotor status, or global cardiac efficiency. By using this technique, several studies highlighted a wide variability in the individual response of patients undergoing cardiovascular stabilization guided by SSG. This suggests that the implementation of a "customized" resuscitation protocol based TPTD derived parameters rather than resuscitation strategy guided by a fixed mathematic model, could be preferred. However, in daily clinical practice, the use of this advanced hemodynamic monitoring system in not routinely used, though it is often reserved in case of failure of the initial SSG-resuscitation protocol.

The investigators supposed that, even if the initial resuscitative efforts were successful in achieving the SSG targets i.e. by restoring the MAP > 65 mmHg, this could still be inadequate in some patients. Accordingly, the investigators hereby will report the hemodynamic profile of patients with septic shock admitted in ICU.

注册库
clinicaltrials.gov
开始日期
2018年3月1日
结束日期
2019年5月1日
最后更新
2年前
研究类型
Observational
性别
All

研究者

发起方
University of Bari
责任方
Principal Investigator
主要研究者

Salvatore Grasso

Director

University of Bari

入排标准

入选标准

  • older than 18 years
  • admitted in ICU with diagnosis of septic shock

排除标准

  • Contraindication at the insertion of the PiCCO catheter; conditions able to bias the transpulmonary thermodilution technique results (atrial fibrillation, extracorporeal membrane oxygenation, valvular disease and/or cardiomyopathy
  • Pre-existing respiratory and cardiovascular pathologies
  • Pre-existing kidney pathologies

结局指标

主要结局

change in Cardiac function index

时间窗: change from baseline cardiac funziona index (1/min) at 5 hours

This study aims to assess potential difference in term of cardiac function in septic patient after an initial standardized resuscitation protocol. the cardiac function will be assess thought the PiCCO monitoring system i.e. by assessing the CFI value (1/min).

研究点 (1)

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