An observational study in Shock, sponsored by Bicetre Hospital. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-21.
Sponsored by Bicetre Hospital · Observational
When the flow of blood ejected by the heart drops significantly, that is to say when there is "shock", one of the first treatments undertaken is often volume expansion. This treatment consists of injecting a liquid intravenously, generally in the form of a bolus, that is to say a dose of solute administered all at once, of 250 to 500 mL of fluid over approximately 10 to 30 minutes. The injected fluid expands the blood volume and fills the heart pump, in order to increase the flow it ejects.
However, this treatment poses two problems. First, it is only inconsistently effective. It is possible that of the 250-500 mL of fluid administered in the standard way, only a part is effective, whereas, as the effectiveness decreases during the infusion, the rest does not increase cardiac output significantly.
However, the average part of the total volume that is ineffective on a large population of patients is not well known.
Second, the effects of volume expansion on cardiac output decrease rapidly after the end of administration. However, the average duration of effectiveness of a 250-500 mL fluid bolus, and the factors that influence this duration of effectiveness, are not well determined.
The main objective of this research is to measure, among the volume of a fluid bolus, which part does not significantly increase cardiac output. The secondary objective is to measure the average time of effectiveness after the end of the infusion and the factors that influence it.
487 studies on the registry are indexed under Shock; 107 are open to participants now.
This study's planned enrollment of 500 is above the median of 100 across 247 observational studies indexed under Shock.
Browse Shock studies →Bicetre Hospital is the lead sponsor of 25 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients hospitalized in intensive care unit and with shock for whom a fluid challenge is administered
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Fluid bolus of 500 mL of crystalloids given at a constant rate between 10 and 15 minutes
To measure, during the administration of a fluid bolus in order to perform volume expansion, the volume of fluid which causes an increase in cardiac output of less than 15%.
We will measure, among the volume administered (500mL), the proportion of infused volume which allowed an increase in cardiac output ≥15% compared to the baseline value. This baseline value will be defined by the average measured over the minute preceding the start of the fluid infusion
Time frame: During the fluid bolus administration (<15min)
The maximum amplitude of the change induced by volume expansion in cardiac output, mean arterial pressure and central venous pressure
The maximum amplitude, expressed as an absolute value and as a percentage of the baseline value, as defined above, of the change induced by volume expansion in cardiac output, mean arterial pressure and central venous pressure
Time frame: During the fluid bolus administration (<15min)
The delay at which this maximum effect appears in terms of cardiac output, mean arterial pressure and central venous pressure
Time frame: During the fluid bolus administration (<15min)
The time following the end of the infusion from which the cardiac output becomes ≤5% of the baseline value
Time frame: A period of 120 minutes following the fluid infusion
The factors that influence these pharmacokinetic variables will be determined
Time frame: During the study period (during fluid administration and the period of 120 minutes following the infusion)
Plan to share: Yes
Supporting information: Study protocol, Informed consent form, Clinical study report
No publications or documents are linked to this record.
Started Jul 2022 (actual). Primary completion is estimated for Jun 2027, 59 months after the start.
Of 120 non-industry observational studies under Shock, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 52. This study's planned 59 months is above that.
Counting every sponsor, half of 127 studies reached it within 26 months; a quarter within 12 and three quarters within 52.
How these figures are worked out, and which studies are left out of them.
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Bicetre Hospital