Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 9:34 PM
Ignite Modification Date:
2025-12-24 @ 9:34 PM
NCT ID:
NCT05271032
Brief Summary:
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.
Study:
NCT05271032
Study Brief:
Protocol Section:
NCT05271032