PICCO ASSESSMENT IN SEPTIC PATIENTS

Sponsor

University of Bari (Other)

Overall Status

Completed

CT.gov ID

NCT05271032

Collaborator

(none)

Enrollment

Location

Actual Duration (Months)

3.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Septic Shock	Diagnostic Test: use of Trasnpulmonary termodiluetion technique

Study Design

Study Type:

Observational

Actual Enrollment :

43 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Mar 1, 2018

Actual Primary Completion Date :

Mar 1, 2019

Actual Study Completion Date :

May 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Septic Patients	Diagnostic Test: use of Trasnpulmonary termodiluetion technique 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

Arm

Intervention/Treatment

Septic Patients

Diagnostic Test: use of Trasnpulmonary termodiluetion technique

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

Outcome Measures

Primary Outcome Measures

change in Cardiac function index [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Salvatore Grasso	Bari		Italy	70124

Sponsors and Collaborators

University of Bari

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Salvatore Grasso, Director, University of Bari

ClinicalTrials.gov Identifier:

NCT05271032

Other Study ID Numbers:

TPTD_CFI01

First Posted:

Mar 8, 2022

Last Update Posted:

Mar 8, 2022

Last Verified:

Feb 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Shock, Septic

Study Results

No Results Posted as of Mar 8, 2022