Comparison of 250 ml Versus 500 ml of Fluid Challenge

NCT03874923 | Completed

• 1 other identifier: PI2018_843_0034
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Fluid Challenge; Oxygen Consumption; Critical Care

Keywords

fluid expansion; oxygen delivery; tissue perfusion; cardiac output

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• Change of arterial lactate concentration from baseline

  30 minutes after fluid challenge.

• Change of arterial lactate concentration from baseline

  60 minutes after fluid challenge.

• Respiratory variation of stroke volume

  Immediately, 30 and 60 minutes after fluid challenge.

• PaO2/FiO2

  Immediately, 30 and 60 minutes after fluid challenge.

• Respiratory variation of the pulse pressure

  30 and 60 minutes after fluid challenge.

Study Arms (2)

250 mL of fluid challenge

ACTIVE COMPARATOR

Other: Fluid challenge

500 mL of fluid challenge

EXPERIMENTAL

Other: Fluid challenge

Interventions

Fluid challenge OTHER

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.

250 mL of fluid challenge; 500 mL of fluid challenge

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Age Under 18-year-old.
• Pregnancy.

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead
• Centre Hospitalier Universitaire Dijon: collaborator

Study Sites (1)

CHU Amiens Picardie

Amiens, France

Location

Study Officials

• Osama Abou-Arab, Dr

  CHU Amiens

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2019
• First Posted: March 14, 2019
• Study Start: March 1, 2019
• Primary Completion: May 24, 2021
• Study Completion: August 30, 2023
• Last Updated: August 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)