SepsisECOVENNCT06156072
Ultrasound-guided Blood Sampling Drawing for Microbiological Analysis in the Critically Ill
An observational study of Sepsis and Septic Shock, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
Trial summary
This study will test the feasibility of ultrasound-guided sterile blood sampling for critically ill patients with suspected sepsis requiring blood culture. The aim of the study is to evaluate the feasibility and safety of the use of ultrasound for blood cultures in a population of patients which can present difficult… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Septic Shock, Infections
- What is being tested?
- Ultrasound-guided venipuncture
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jun 2025to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Alla adult patients admitted to ICU with a suspected sepsis will be enrolled, when treating physician will prescribe blood culture for microbiological analysis
Who may be able to join
- Adult patients (18 year-old)
- admitted to intensive care unit
- suspected sepsis requiring blood cultrure
Who cannot join
- pregnancy
- infections requiring respiratory isolation
- burns or skin disease involving arms and/or more than 60% of body surface
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Use of Ultrasound for Blood Sample Drawing for Microbiological Analysis in Critically Ill Patients:he ECOVEN Feasibility Study
This study will test the feasibility of ultrasound-guided sterile blood sampling for critically ill patients with suspected sepsis requiring blood culture. The aim of the study is to evaluate the feasibility and safety of the use of ultrasound for blood cultures in a population of patients which can present difficult venous access and requiring more than one venipuncture attempt in general clinical practice
- Conditions
- Sepsis, Septic Shock, Infections, Diagnosis
- Being tested
- Ultrasound-guided venipuncture
- Medical subject headings
- Sepsis, Shock, Septic, Infections, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-guided venipunctureDiagnostic test
Venipuncture will be performed using ultrasound to identify the most appropriate vessel and guide the puncture
| Study group | Role | What they receive |
|---|---|---|
| Patient requiring blood culture | After the request of treating physician of blood culture, each patient deemed eligible, will undergo the prescirbed couple of peripheral blood samples. The first one will be done with the classical blind technique, while the second one with ultrasound guidance. Receives: Diagnostic Test: Ultrasound-guided venipuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of attempted venipunctures
Evaluation of the feasibility of ultrasound-guided venipuncture for blood samples in patients requiring ,microbiological analysis. Feasibility will be evaluated in terms of number of needed attempts of venipuncture
Measured: One hour after clinical decision of blood culture execution
Secondary outcomes (2)
Incidence of possible complications (accidental arterial puncture, visible ematoma)
Evaluation of safety of venipuncture in terms of possible complications (accidental arterial puncture, ematoma)
Measured: One hour after clinical decision of blood culture execution
Incidence of contamination of ultrasound-guided venipuncture
Evaluation of blood sample bacterial contamination compared to blind puncture
Measured: One hour after clinical decision of blood culture execution
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2023
- Study startJun 2025 (estimated)
- Primary completion30 Jun 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- 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 crossover
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LA BELLA MARIACARMEN, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Investigators
- Antonio M Dell'Anna, M.D., Study chair, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06156072
- Sponsor's protocol ID
- 6046
- Acronym
- ECOVEN
- Status last verified
- Feb 2025
- First submitted
- 21 Nov 2023
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Ultrasound for Blood Sample Drawing for Microbiological Analysis in Critically Ill Patients:he ECOVEN Feasibility Study
- ClinicalTrials.gov ID
- NCT06156072
- Acronym / sponsor ID
- ECOVEN / 6046
- Conditions
- Sepsis, Septic Shock, Infections, Diagnosis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- Jun 2025 (estimated)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 5 Dec 2023 (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.
This study will test the feasibility of ultrasound-guided sterile blood sampling for critically ill patients with suspected sepsis requiring blood culture. The aim of the study is to evaluate the feasibility and safety of the use of ultrasound for blood cultures in a population of patients which can present difficult venous access and requiring more than one venipuncture attempt in general clinical practice
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient requiring blood culture | – | Diagnostic Test: Ultrasound-guided venipunctureAfter the request of treating physician of blood culture, each patient deemed eligible, will undergo the prescirbed couple of peripheral blood samples. The first one will be done with the classical blind technique, while the second one with ultrasound guidance. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Alla adult patients admitted to ICU with a suspected sepsis will be enrolled, when treating physician will prescribe blood culture for microbiological analysis
Key inclusion criteria (3 listed)
- Adult patients (18 year-old)
- admitted to intensive care unit
- suspected sepsis requiring blood cultrure
Key exclusion criteria (3 listed)
- pregnancy
- infections requiring respiratory isolation
- burns or skin disease involving arms and/or more than 60% of body surface
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 |
|---|---|---|
| Ultrasound-guided venipunctureVenipuncture will be performed using ultrasound to identify the most appropriate vessel and guide the puncture | Diagnostic test | Patient requiring blood culture |
Primary outcome
Number of attempted venipunctures
Time frame: One hour after clinical decision of blood culture execution
Evaluation of the feasibility of ultrasound-guided venipuncture for blood samples in patients requiring ,microbiological analysis. Feasibility will be evaluated in terms of number of needed attempts of venipuncture
2 secondary outcomes
Incidence of possible complications (accidental arterial puncture, visible ematoma)
Time frame: One hour after clinical decision of blood culture execution
Incidence of contamination of ultrasound-guided venipuncture
Time frame: One hour after clinical decision of blood culture execution
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
- Individual participant dataSharing planned: Undecided
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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.
Antonio M Dell'Anna, M.D. study chair
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and Septic Shock, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
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 3 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: opening soon, as of the sponsor's last update on 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Antonio M Dell'Anna, M.D. (3803679256, antoniomaria.dellanna@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of attempted venipunctures (time frame: One hour after clinical decision of blood culture execution). 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 12 Mar 2025.