An observational study in Shock, Septic, Hyperlactatemia and Oliguria, sponsored by Central Hospital, Nancy, France. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-05-18.
Sponsored by Central Hospital, Nancy, France · Observational
The MostCare system, thanks to the Pressure Recording Analytical Method (PRAM; Vygon, Padua, Italy), provides new hemodynamic parameters of the cardiovascular system. The PRAM method is a noncalibrated pulse contour method which requires only an arterial line (radial or femoral). This method has been validated in various clinical conditions. Among the collected parameters, some are well known and used daily care in Intensive Care Unit (ICU), i.e. cardiac output (CO), arterial pressure, heart rate, stroke volume (SV). Others such as arterial elastance (Ea) or dicrotic pressure are more recent and merit further investigation to determine their interest in clinical practice. To date, it is rarely used to adapt therapies, mostly because of a lack of knowledge regarding the evolution of these parameters.
The aim of this study is to analyze the relationship between the evolution of Arterial Elastance and fluid responsiveness after a 250 mL fluid challenge of crystalloids in 5 minutes in patients with either septic shock or in the postoperative course of a major vascular surgery.
Patients will be considered fluid responders if an increase >10% of the stroke volume is observed .
1,078 studies on the registry are indexed under Shock, Septic; 232 are open to participants now.
This study's planned enrollment of 80 is below the median of 108 across 406 observational studies indexed under Shock, Septic.
Browse Shock, Septic studies →Central Hospital, Nancy, France is the lead sponsor of 798 studies on the registry; 186 are open to participants now.
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The study population is a mix of septic shock and patients who underwent elective or emergent major vascular surgery surgery (aortic mostly) requiring a fluid challenge because of hypotension and/or oliguria and/or mottling and/or hyperlactatemia>2mmol/L. All patients will be hospitalized in the surgical intensive care unit (ICU) of the University Hospital of Nancy Brabois, France.
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Exclusion Criteria:
Patients with septic shock, according to the Sepsis 3 definition, regardless of the origin
Drug: Fluid challenge
Patients who underwent elective or emergent major vascular surgery abdominal aortic surgery (open or endovascular surgery)
Drug: Fluid challenge
All patients who met the inclusion criteria will receive a standardised bolus of 250 ml of crystalloid in 5 minutes administered by hand with a 50 ml syringe. During the study period, hemodynamic parameters and analysis by pressure recording analytical method obtained with the MostCare will be collected for 20 minutes prior to the intervention (fluid challenge), during the fluid challenge and 25 minutes after completion. The total duration of the intervention (fluid loading) is 5 min. The total duration of hemodynamic parameters recording is 60 min.
Evolution of arterial elastance
Absolute and percentage of change in arterial elastance during the study period
Time frame: 60 minutes
Evolution of Stroke Volume (SV)
Absolute and percentage of change in stroke volume during the study period
Time frame: 60 minutes
Evolution of Dicrotic Pressure (DP) value during a fluid challenge
Absolute and percentage of change in dicrotic pressure during the study period
Time frame: 60 minutes
Predictive factors of an increase or a decrease in the arterial elastance value
Identification of clinical or arterial pressure waveform parameters associated with an increase or a decrease of the arterial elastance * epidemiological and clinical: age, BMI, gender, SAPS II, SOFA, Charlson comorbidity index, chronic diseases, etiology of the septic shock, acute kidney injury * therapeutical: chronic treatments, vasoactive and sedative drugs, epidural analgesia, mechanical ventilation (VT, RR, PEEP) * surgery: type of surgery (open or endovascular), indication, timing. * indication for fluid loading: hypotension, oliguria, hyperlactatemia \> 2mmol/L, mottling
Time frame: 60 minutes
Predictive factors of an increase or a decrease of the dicrotic pressure value
Identification of clinical or arterial pressure waveform parameters associated with an increase or a decrease of the dicrotic pressure
Time frame: 60 minutes
Evolution of norepinephrine dose: before and 60 minutes after fluid challenge
Norepinephrine dose expressed in micrograms per kilogram per minute (μg/kg/min)
Time frame: 60 minutes
All-cause mortality
30 days all-cause mortality
Time frame: 30 days
Started Feb 2019 (actual). Primary completion is estimated for Jun 2020, 16 months after the start.
Of 189 non-industry observational studies under Shock, Septic, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 47. This study's planned 16 months is below that.
Counting every sponsor, half of 202 studies reached it within 25 months; a quarter within 12 and three quarters within 47.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.
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