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Completed

NCT Number: NCT05271032

PiCCO ASSESSMENT IN PATIENTS WITH SEPTIC SHOCK

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.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Salvatore Grasso

Bari, 70124, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

use of Trasnpulmonary termodiluetion technique

Diagnostic Test

All the patients underwent to invasive hemodynamic monitoring through the transpulmonary thermodilution technique (PiCCO, PULSION medical system. Gettinge; Solna, Sweden). Briefly, the technique consists in the administration of a cold saline bolus in superior vena cava while monitoring the corresponding temperature variation through a femoral arterial catheter equipped with a tip thermistor. Accordingly, a 5 French catheter equipped with a tip thermistor was inserted into the femoral artery.

Other names: Picco

Primary outcomes

  1. change in Cardiac function index

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

University of Bari

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 8, 2022
Registry last updated
May 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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