An observational study in Sepsis With Hemodynamic Instability, sponsored by Nantes University Hospital. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-06-13.
Sponsored by Nantes University Hospital · Observational
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.
1,899 studies on the registry are indexed under Sepsis; 462 are open to participants now.
This study's enrollment of 26 is below the median of 160 across 931 observational studies indexed under Sepsis.
Browse Sepsis studies →Nantes University Hospital is the lead sponsor of 825 studies on the registry; 195 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Major patients with sepsis requiring vascular filling
Exclusion Criteria :
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.
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
Time frame: 5 months
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.
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)
Pulmonary ITV and Aortic ITV
Time frame: 5 months
This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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Nantes University Hospital