Septic ShockNCT05271032
PiCCO ASSESSMENT IN PATIENTS WITH SEPTIC SHOCK
An observational study of Septic Shock, run by University of Bari at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Septic Shock
- What is being tested?
- use of Trasnpulmonary termodiluetion technique
- How many people
- 43 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2018to 1 May 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: We enrolled patients admitted in ICU with diagnosis of sepsis shock. Sepsis shock was defined as a probable infectious etiology with sequential organ failure assessment score (SOFA) upper than 2, arterial lactate > 2 mmol dL-1 and contextually hypotension refractory to the initial fluid administration followed by the use of vasoconstrictor agent to sustain the mean arterial pressure (MAP) > 65 mmHg.
Who may be able to join
- older than 18 years
- admitted in ICU with diagnosis of septic shock
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: TRANSPULMONARY TERMODILUTION HEMODYNAMIC PROFILE IN PATIENTS WITH SEPTIC SHOCK AFTER INITIAL RESUSCITATION
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".
Read more
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.
- Conditions
- Septic Shock
- Being tested
- use of Trasnpulmonary termodiluetion technique
- Medical subject headings
- Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
use of Trasnpulmonary termodiluetion techniqueDiagnostic test
Also called Picco
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.
| Study group | Role | What they receive |
|---|---|---|
| Septic Patients | Not described Receives: Diagnostic Test: use of Trasnpulmonary termodiluetion technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in Cardiac function index
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).
Measured: change from baseline cardiac funziona index (1/min) at 5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2022
- Study start1 Mar 2018
- Primary completion1 Mar 2019
- Study completion1 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bari
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Salvatore Grasso, University of Bari
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05271032
- Sponsor's protocol ID
- TPTD_CFI01
- Status last verified
- May 2023
- First submitted
- 20 Jan 2022
- Last updated
- 18 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TRANSPULMONARY TERMODILUTION HEMODYNAMIC PROFILE IN PATIENTS WITH SEPTIC SHOCK AFTER INITIAL RESUSCITATION
- ClinicalTrials.gov ID
- NCT05271032
- Acronym / sponsor ID
- TPTD_CFI01
- Conditions
- Septic Shock
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- University of BariUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 1 May 2019 (actual)
- First posted
- 8 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Septic Patients | – | Diagnostic Test: use of Trasnpulmonary termodiluetion technique |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- We enrolled patients admitted in ICU with diagnosis of sepsis shock. Sepsis shock was defined as a probable infectious etiology with sequential organ failure assessment score (SOFA) upper than 2, arterial lactate > 2 mmol dL-1 and contextually hypotension refractory to the initial fluid administration followed by the use of vasoconstrictor agent to sustain the mean arterial pressure (MAP) > 65 mmHg.
Key inclusion criteria (2 listed)
- older than 18 years
- admitted in ICU with diagnosis of septic shock
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| use of Trasnpulmonary termodiluetion techniqueAlso: PiccoAll 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. | Diagnostic test | Septic Patients |
Primary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2023.
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Sepsis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Septic Shock, run by University of Bari at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in Cardiac function index (time frame: change from baseline cardiac funziona index (1/min) at 5 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2023.