Comparison of 250 ml Versus 500 ml of Fluid Challenge

Study Overview
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Brief Summary
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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.

Official Title
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Comparison of 250 ml Versus 500 ml of Fluid Challenge on Oxygen Consumption in Critical Care Patients: an Open Label Multicentre Prospective Study

Conditions
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Fluid Challenge, Oxygen Consumption, Critical Care

Intervention / Treatment
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* Other: Fluid challenge


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 250 mL of fluid challenge<br> | Other: Fluid challenge<br>* After randomisation, patient will receive 250 ml or 500 ml of fluid challenge. VO2 will be assessed before fluid challenge, immediately, 30 minutes and 60 minutes after fluid challenge.<br>|
| Experimental: 500 mL of fluid challenge<br> | Other: Fluid challenge<br>* After randomisation, patient will receive 250 ml or 500 ml of fluid challenge. VO2 will be assessed before fluid challenge, immediately, 30 minutes and 60 minutes after fluid challenge.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VO2 after fluid challenge | Tissue oxygen consumption (VO2) after fluid challenge | 30 minutes after fluid challenge. | 
| VO2 after fluid challenge | Tissue oxygen consumption (VO2) after fluid challenge | 60 minutes after fluid challenge. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of arterial lactate concentration from baseline | Baseline is the measurement of arterial lactate concentration immediately after fluid challenge | 30 minutes after fluid challenge. | 
| Change of arterial lactate concentration from baseline | Baseline is the measurement of arterial lactate concentration immediately after fluid challenge | 60 minutes after fluid challenge. | 
| Respiratory variation of stroke volume | Respiratory variation of stroke volume after fluid challenge. | Immediately, 30 and 60 minutes after fluid challenge. | 
| PaO2/FiO2 | PaO2/FiO2 ratio (ratio of arterial oxygen partial pressure to fractional inspired oxygen) after fluid challenge | Immediately, 30 and 60 minutes after fluid challenge. | 
| Respiratory variation of the pulse pressure | Respiratory variation of the pulse pressure | 30 and 60 minutes after fluid challenge. | 
| Stroke volume variation with passive leg raising (PLV) | Stroke volume variation with passive leg raising (PLV) | 30 and 60 minutes after fluid challenge. | 
| Systolic heart function (LVEF) | Systolic heart function (LVEF) | Immediately, 30 and 60 minutes after fluid challenge. | 
| Diastolic heart function | Diastolic heart function (E, A, E', A', S' waves) | Immediately, 30 and 60 minutes after fluid challenge. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fluid expansion, oxygen delivery, tissue perfusion, cardiac output