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Completed

NCT Number: NCT03874923

Comparison of 250 ml Versus 500 ml of Fluid Challenge

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.

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Key information

Conditions

Fluid Challenge Critical Care Oxygen Consumption

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Amiens Picardie

Amiens, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. VO2 after fluid challenge

    Time frame: 30 minutes after fluid challenge.

    Tissue oxygen consumption (VO2) after fluid challenge

  2. VO2 after fluid challenge

    Time frame: 60 minutes after fluid challenge.

    Tissue oxygen consumption (VO2) after fluid challenge

Secondary outcomes

  1. Change of arterial lactate concentration from baseline

    Time frame: 30 minutes after fluid challenge.

    Baseline is the measurement of arterial lactate concentration immediately after fluid challenge

  2. Change of arterial lactate concentration from baseline

    Time frame: 60 minutes after fluid challenge.

    Baseline is the measurement of arterial lactate concentration immediately after fluid challenge

  3. Respiratory variation of stroke volume

    Time frame: Immediately, 30 and 60 minutes after fluid challenge.

    Respiratory variation of stroke volume after fluid challenge.

  4. PaO2/FiO2

    Time frame: Immediately, 30 and 60 minutes after fluid challenge.

    PaO2/FiO2 ratio (ratio of arterial oxygen partial pressure to fractional inspired oxygen) after fluid challenge

  5. Respiratory variation of the pulse pressure

    Time frame: 30 and 60 minutes after fluid challenge.

    Respiratory variation of the pulse pressure

  6. Stroke volume variation with passive leg raising (PLV)

    Time frame: 30 and 60 minutes after fluid challenge.

    Stroke volume variation with passive leg raising (PLV)

  7. Systolic heart function (LVEF)

    Time frame: Immediately, 30 and 60 minutes after fluid challenge.

    Systolic heart function (LVEF)

  8. Diastolic heart function

    Time frame: Immediately, 30 and 60 minutes after fluid challenge.

    Diastolic heart function (E, A, E', A', S' waves)

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Collaborators

  • Centre Hospitalier Universitaire Dijon

Registry information

Official study title

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

Acronym: KOBIAS

Important dates

Study start
2019
Primary completion
2021
Study completion
2023
First posted
Mar 14, 2019
Registry last updated
Aug 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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