Comparison of 250 ml Versus 500 ml of Fluid Challenge

Not Applicable

Completed

• Conditions: Fluid Challenge; Oxygen Consumption; Critical Care
• Interventions: Other: Fluid challenge

• Registration Number: NCT03874923
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-01
• Study First Submitted: 2019-03-07
• Study First Submitted QC: 2019-03-12
• Study First Posted: 2019-03-14
• Primary Completion: 2021-05-24
• Study Completion: 2023-08-30
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-09
• Last Update Posted: 2024-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
250 mL of fluid challenge	Fluid challenge	-
500 mL of fluid challenge	Fluid challenge	-

Primary Outcome Measures

Name	Time	Method
VO2 after fluid challenge	60 minutes after fluid challenge.	Tissue oxygen consumption (VO2) after fluid challenge

Secondary Outcome Measures

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

Trial Locations

Locations (1)

CHU Amiens Picardie; 🇫🇷 Amiens, France