Comparison of 250 ml Versus 500 ml of Fluid Challenge

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03874923

Acronym

KOBIAS

Enrollment

Registered

2019-03-14

Start date

2019-03-01

Completion date

2023-08-30

Last updated

2025-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Care, Fluid Challenge, Oxygen Consumption

Keywords

fluid expansion, oxygen delivery, tissue perfusion, cardiac output

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.

Interventions

OTHERFluid challenge

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
VO2 after fluid challenge	30 minutes after fluid challenge.	Tissue oxygen consumption (VO2) after fluid challenge

Secondary

Measure	Time frame	Description
Respiratory variation of stroke volume	Immediately, 30 and 60 minutes after fluid challenge.	Respiratory variation of stroke volume 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
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	30 minutes after fluid challenge.	Baseline is the measurement of arterial lactate concentration immediately after fluid challenge
Systolic heart function (LVEF)	Immediately, 30 and 60 minutes after fluid challenge.	Systolic heart function (LVEF)
Diastolic heart function	Immediately, 30 and 60 minutes after fluid challenge.	Diastolic heart function (E, A, E', A', S' waves)
Stroke volume variation with passive leg raising (PLV)	30 and 60 minutes after fluid challenge.	Stroke volume variation with passive leg raising (PLV)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026