Comparison of 250 ml Versus 500 ml of Fluid Challenge (KOBIAS)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Oxygen Consumption; Critical Care; Fluid Challenge
• Intervention / Treatment: Other: Fluid challenge

• Study Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Amiens, France
    • CHU Amiens Picardie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 250 mL of fluid challenge	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.
Experimental: 500 mL of fluid challenge	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.

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire, Amiens
• Collaborators: Centre Hospitalier Universitaire Dijon
• Investigators: Principal Investigator: Osama Abou-Arab, Dr, CHU Amiens

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2019
• Primary Completion (Actual): May 24, 2021
• Study Completion (Anticipated): August 1, 2023

Study Registration Dates

• First Submitted: March 7, 2019
• First Submitted That Met QC Criteria: March 12, 2019
• First Posted (Actual): March 14, 2019

Study Record Updates

• Last Update Posted (Actual): May 17, 2023
• Last Update Submitted That Met QC Criteria: May 16, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: cardiac output; fluid expansion; oxygen delivery; tissue perfusion
• Other Study ID Numbers: PI2018_843_0034

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No