Comparison of 250 ml Versus 500 ml of Fluid Challenge

Critical Care Clinical Trial

— KOBIAS  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03874923
• Other study ID #: PI2018_843_0034
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: August 2023

Study information

• Verified date: May 2023
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 24
• Est. completion date: August 2023
• Est. primary completion date: May 24, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Critical Care
• Fluid Challenge
• Oxygen Consumption

Intervention

Other:
• Fluid 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.

Locations

Country	Name	City	State
France	CHU Amiens Picardie	Amiens

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens	Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VO2 after fluid challenge	Tissue oxygen consumption (VO2) after fluid challenge	30 minutes after fluid challenge.
Primary	VO2 after fluid challenge	Tissue oxygen consumption (VO2) after fluid challenge	60 minutes after fluid challenge.
Secondary	Change of arterial lactate concentration from baseline	Baseline is the measurement of arterial lactate concentration immediately after fluid challenge	30 minutes after fluid challenge.
Secondary	Change of arterial lactate concentration from baseline	Baseline is the measurement of arterial lactate concentration immediately after fluid challenge	60 minutes after fluid challenge.
Secondary	Respiratory variation of stroke volume	Respiratory variation of stroke volume after fluid challenge.	Immediately, 30 and 60 minutes after fluid challenge.
Secondary	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.
Secondary	Respiratory variation of the pulse pressure	Respiratory variation of the pulse pressure	30 and 60 minutes after fluid challenge.
Secondary	Stroke volume variation with passive leg raising (PLV)	Stroke volume variation with passive leg raising (PLV)	30 and 60 minutes after fluid challenge.
Secondary	Systolic heart function (LVEF)	Systolic heart function (LVEF)	Immediately, 30 and 60 minutes after fluid challenge.
Secondary	Diastolic heart function	Diastolic heart function (E, A, E', A', S' waves)	Immediately, 30 and 60 minutes after fluid challenge.