Clinical trial NCT03874923: Comparison of 250 ml Versus 500 ml of Fluid Challenge
Official title: Comparison of 250 ml Versus 500 ml of Fluid Challenge on Oxygen Consumption in Critical Care Patients: an Open Label Multicentre Prospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fluid Challenge
Oxygen Consumption
Critical Care
Keywords: fluid expansion
oxygen delivery
tissue perfusion
cardiac output
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
Collaborators: name: Centre Hospitalier Universitaire Dijon
First posted: 2019-03-14
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of fluid challenge is to increase oxygen delivery (DO2) in order to improve/restore tissue oxygen consumption (VO2). However the fluid challenge volume to administer stills in debate, some studies recommend to administer 250 mL. Previous studies suggested that 500 mL of fluid challenge administration may improve cardiac output and oxygen delivery. The relation between the amount of fluid expansion and oxygen delivery and oxygen consumption was not yet been studied in a randomized study in critical care patients. This is the purpose of this study.


Eligibility criteria: Inclusion Criteria:

* Patient for whom the physician in charge decided to infuse fluid challenge because of signs of acute circulatory failure (systolic arterial blood pressure \< 90mmHg, and/or mean arterial blood pressure\< 65 mmHg, and/or the need of vasopressive amine infusion, and/or skin mottling, and/or diuresis \<0.5 mL/kg/h for more than 2 hours, and/or arterial lactate level\>2mmol/L.
* Echogenic patient
* Patient with a Stroke Volume (SV) variation with passive leg raising (PLR) more than 10%.
* Patient with regular sinus rhythm.
* Patient who received protocol information.

Exclusion Criteria:

* Age Under 18-year-old.
* Pregnancy.

Primary outcomes:
measure: VO2 after fluid challenge
timeFrame: 30 minutes after fluid challenge.
measure: VO2 after fluid challenge
timeFrame: 60 minutes after fluid challenge.
Secondary outcomes:
measure: Change of arterial lactate concentration from baseline
timeFrame: 30 minutes after fluid challenge.
measure: Change of arterial lactate concentration from baseline
timeFrame: 60 minutes after fluid challenge.
measure: Respiratory variation of stroke volume
timeFrame: Immediately, 30 and 60 minutes after fluid challenge.
measure: PaO2/FiO2
timeFrame: Immediately, 30 and 60 minutes after fluid challenge.
measure: Respiratory variation of the pulse pressure
timeFrame: 30 and 60 minutes after fluid challenge.
measure: Stroke volume variation with passive leg raising (PLV)
timeFrame: 30 and 60 minutes after fluid challenge.
measure: Systolic heart function (LVEF)
timeFrame: Immediately, 30 and 60 minutes after fluid challenge.
measure: Diastolic heart function
timeFrame: Immediately, 30 and 60 minutes after fluid challenge.
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens Picardie
Study officials:
affiliation: CHU Amiens
name: Osama Abou-Arab, Dr
role: PRINCIPAL_INVESTIGATOR
References: