Sepsis With Hemodynamic InstabilityCIAOPNCT04899323
Correlation of Aortic Versus Pulmonary ITV in Response to Vascular Filling
An observational study of Sepsis With Hemodynamic Instability, run by Nantes University Hospital at 1 site in France.
Trial summary
This is a multicenter study conducted in the emergency department of the Nantes University Hospital and the Confluent Private Hospital, over a period of 5 months, based on hemodynamic ultrasound. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis With Hemodynamic Instability
- How many people
- 26 participants
- Where
- 1 siteFrance
- Study dates
- 21 Jul 2021to 1 May 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Major patients with sepsis requiring vascular filling
Who may be able to join
- Age> 18 years
- Patient with suspected infectious syndrome
- qSOFA >= 2
- Tachycardia>120 and/or PAS < 100mm Hg / MAP <60 mmHg
Who cannot join
- Atrial fibrillation arrhythmia
- Vascular filling > 500 ml before hemodynamic evaluation by echo cardiography
- Perfusion of catecholamine (norepinephrine, epinephrine, or dobutamine) at the time of inclusion in the study (before hemodynamic assessment by echo cardiography)
- Patient sedated and on positive pressure ventilation, including NIV
- Tamponade due to a compressive pericardial or pleural effusion
- Patient with known pre-capillary PAH > 50 mmHg PAPS
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- Presence of suspected acute valvulopathy requiring immediate cardiological expertise
- Absence of an acoustic window allowing the evaluation of the aortic or pulmonary ITV
- Minor patients, adults under guardianship, protected persons
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Compares Changes in Pulmonary ITV Secondary to Vascular Filling to Reference Values Represented by Changes in Subaortic ITV in the Management of Sepsis in the Emergency Department.
This is a multicenter study conducted in the emergency department of the Nantes University Hospital and the Confluent Private Hospital, over a period of 5 months, based on hemodynamic ultrasound.
For each patient admitted to an emergency department with a sepsis syndrome requiring vascular filling, the pulmonary ITV and the aortic ITV were measured at each phase of vascular filling.
Read more
This is a non-interventional study, the management of patients will not differ from usual practices and vascular filling should not be delayed in any case. Emergency doctors who are already experts in ultrasound, monitoring vascular filling by measuring the aortic ITV, will have to measure the pulmonary ITV after each filling of 250cc of Ringer's Lactate in 10 minutes with a limited amount of time.
The evolution of ITV measurements and vital parameters should be recorded for each patient.
In order to ensure quality, the emergency doctors will first receive a short training (presentation of the study and review of the measurements requested). In addition, measurement records will be analyzed at random.
At the end of this study, the correlation between the variation of the aortic and pulmonary ITV could be compared. The objective would be to promote the monitoring of these unstable patients via the pulmonary ITV. This measurement would be easier to perform than the aortic ITV, which is currently only performed by emergency doctors who are experts in hemodynamic ultrasound.
- Conditions
- Sepsis With Hemodynamic Instability
- Keywords
- Aortic ITV, Pulmonary ITV, Cardiac ultrasound, Hemodynamic ultrasound, Vascular filling, Sepsis, Emergency medicine, Recommendations
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort | Perform a 250cc vascular filling over 10 minutes and then perform a cardiac ultrasound. Repeat the vascular filling followed by the ultrasound as long as the patient is responsive. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demonstration of a correlation between changes in pulmonary ITV secondary to vascular filling and reference values represented by changes in subaortic ITV.
Aortic ITV and pulmonary ITV
Measured: 5 months
Secondary outcomes (2)
Investigate whether pulmonary ITV is more feasible than aortic ITV.
Proportion of cases where Aortic ITV measurement is not feasible as opposed to pulmonary ITV.
Measured: 5 months
Exploratory search for an indicator threshold for pulmonary ITV corresponding to the 10% threshold of aortic ITV (provided that pulmonary ITV and aortic ITV are correlated)
Pulmonary ITV and Aortic ITV
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2021
- Study start21 Jul 2021
- Primary completion1 May 2023
- Study completion1 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sepsis With Hemodynamic InstabilityStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04899323
- Sponsor's protocol ID
- RC21_0026
- Acronym
- CIAOP
- Status last verified
- Jun 2023
- First submitted
- 19 May 2021
- Last updated
- 13 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compares Changes in Pulmonary ITV Secondary to Vascular Filling to Reference Values Represented by Changes in Subaortic ITV in the Management of Sepsis in the Emergency Department.
- ClinicalTrials.gov ID
- NCT04899323
- Acronym / sponsor ID
- CIAOP / RC21_0026
- Conditions
- Sepsis With Hemodynamic Instability
- Keywords
- Aortic ITV, Pulmonary ITV, Cardiac ultrasound, Hemodynamic ultrasound, Vascular filling, Sepsis, Emergency medicine, Recommendations
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 21 Jul 2021 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 24 May 2021 (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 is a multicenter study conducted in the emergency department of the Nantes University Hospital and the Confluent Private Hospital, over a period of 5 months, based on hemodynamic ultrasound.
For each patient admitted to an emergency department with a sepsis syndrome requiring vascular filling, the pulmonary ITV and the aortic ITV were measured at each phase of vascular filling.
This is a non-interventional study, the management of patients will not differ from usual practices and vascular filling should not be delayed in any case. Emergency doctors who are already experts in ultrasound, monitoring vascular filling by measuring the aortic ITV, will have to measure the pulmonary ITV after each filling of 250cc of Ringer's Lactate in 10 minutes with a limited amount of time.
The evolution of ITV measurements and vital parameters should be recorded for each patient.
In order to ensure quality, the emergency doctors will first receive a short training (presentation of the study and review of the measurements requested). In addition, measurement records will be analyzed at random.
At the end of this study, the correlation between the variation of the aortic and pulmonary ITV could be compared. The objective would be to promote the monitoring of these unstable patients via the pulmonary ITV. This measurement would be easier to perform than the aortic ITV, which is currently only performed by emergency doctors who are experts in hemodynamic ultrasound.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort | – | –Perform a 250cc vascular filling over 10 minutes and then perform a cardiac ultrasound. Repeat the vascular filling followed by the ultrasound as long as the patient is responsive. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Major patients with sepsis requiring vascular filling
Key inclusion criteria (4 listed)
- Age> 18 years
- Patient with suspected infectious syndrome
- qSOFA >= 2
- Tachycardia>120 and/or PAS < 100mm Hg / MAP <60 mmHg
Key exclusion criteria (9 listed)
- Atrial fibrillation arrhythmia
- Vascular filling > 500 ml before hemodynamic evaluation by echo cardiography
- Perfusion of catecholamine (norepinephrine, epinephrine, or dobutamine) at the time of inclusion in the study (before hemodynamic assessment by echo cardiography)
- Patient sedated and on positive pressure ventilation, including NIV
- Tamponade due to a compressive pericardial or pleural effusion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Demonstration of a correlation between changes in pulmonary ITV secondary to vascular filling and reference values represented by changes in subaortic ITV.
Time frame: 5 months
Aortic ITV and pulmonary ITV
2 secondary outcomes
Investigate whether pulmonary ITV is more feasible than aortic ITV.
Time frame: 5 months
Exploratory search for an indicator threshold for pulmonary ITV corresponding to the 10% threshold of aortic ITV (provided that pulmonary ITV and aortic ITV are correlated)
Time frame: 5 months
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 13 Jun 2023.
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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. 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 Sepsis With Hemodynamic Instability, run by Nantes University Hospital at 1 site in France.
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 4 inclusion and 9 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 13 Jun 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 France. 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?
Demonstration of a correlation between changes in pulmonary ITV secondary to vascular filling and reference values represented by changes in subaortic ITV. (time frame: 5 months). 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 13 Jun 2023.