Fluid ChallengeKOBIASNCT03874923
Comparison of 250 ml Versus 500 ml of Fluid Challenge
A study testing Fluid challenge in people with Fluid Challenge and Oxygen Consumption, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fluid Challenge, Oxygen Consumption, Critical Care
- What is being tested?
- Fluid challenge
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2019to 30 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Age Under 18-year-old.
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Fluid challenge
- Keywords
- fluid expansion, oxygen delivery, tissue perfusion, cardiac output
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluid challengeOther
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 group | Role | What they receive |
|---|---|---|
| 250 mL of fluid challenge | Active comparator | Not described Receives: Other: Fluid challenge |
| 500 mL of fluid challenge | Experimental | Not described Receives: Other: Fluid challenge |
What is being measured
The primary outcome is the main question the study is designed to answer.
VO2 after fluid challenge
Tissue oxygen consumption (VO2) after fluid challenge
Measured: 30 minutes after fluid challenge.
VO2 after fluid challenge
Tissue oxygen consumption (VO2) after fluid challenge
Measured: 60 minutes after fluid challenge.
Secondary outcomes (8)
Change of arterial lactate concentration from baseline
Baseline is the measurement of arterial lactate concentration immediately after fluid challenge
Measured: 30 minutes after fluid challenge.
Change of arterial lactate concentration from baseline
Baseline is the measurement of arterial lactate concentration immediately after fluid challenge
Measured: 60 minutes after fluid challenge.
Respiratory variation of stroke volume
Respiratory variation of stroke volume after fluid challenge.
Measured: 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
Measured: Immediately, 30 and 60 minutes after fluid challenge.
Respiratory variation of the pulse pressure
Respiratory variation of the pulse pressure
Measured: 30 and 60 minutes after fluid challenge.
Stroke volume variation with passive leg raising (PLV)
Stroke volume variation with passive leg raising (PLV)
Measured: 30 and 60 minutes after fluid challenge.
Systolic heart function (LVEF)
Systolic heart function (LVEF)
Measured: Immediately, 30 and 60 minutes after fluid challenge.
Diastolic heart function
Diastolic heart function (E, A, E', A', S' waves)
Measured: Immediately, 30 and 60 minutes after fluid challenge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2019
- Study start1 Mar 2019
- Primary completion24 May 2021
- Study completion30 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fluid ChallengeStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier Universitaire Dijon
- Responsible party
- Sponsor
- Investigators
- Osama Abou-Arab, Dr, Principal investigator, CHU Amiens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03874923
- Sponsor's protocol ID
- PI2018_843_0034
- Acronym
- KOBIAS
- Status last verified
- Aug 2025
- First submitted
- 7 Mar 2019
- Last updated
- 8 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03874923
- Acronym / sponsor ID
- KOBIAS / PI2018_843_0034
- Conditions
- Fluid Challenge, Oxygen Consumption, Critical Care
- Keywords
- fluid expansion, oxygen delivery, tissue perfusion, cardiac output
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Collaborators
- Centre Hospitalier Universitaire Dijon
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 24 May 2021 (actual)
- Study completion
- 30 Aug 2023 (actual)
- First posted
- 14 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 250 mL of fluid challenge | Active comparator | Other: Fluid challenge |
| 500 mL of fluid challenge | Experimental | Other: Fluid challenge |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- Age Under 18-year-old.
- Pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluid challengeAfter 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. | Other | 250 mL of fluid challenge, 500 mL of fluid challenge |
Primary outcome
VO2 after fluid challenge
Time frame: 30 minutes after fluid challenge.
Tissue oxygen consumption (VO2) after fluid challenge
VO2 after fluid challenge
Time frame: 60 minutes after fluid challenge.
Tissue oxygen consumption (VO2) after fluid challenge
8 secondary outcomes
Change of arterial lactate concentration from baseline
Time frame: 30 minutes after fluid challenge.
Change of arterial lactate concentration from baseline
Time frame: 60 minutes after fluid challenge.
Respiratory variation of stroke volume
Time frame: Immediately, 30 and 60 minutes after fluid challenge.
PaO2/FiO2
Time frame: Immediately, 30 and 60 minutes after fluid challenge.
Respiratory variation of the pulse pressure
Time frame: 30 and 60 minutes after fluid challenge.
Stroke volume variation with passive leg raising (PLV)
Time frame: 30 and 60 minutes after fluid challenge.
Systolic heart function (LVEF)
Time frame: Immediately, 30 and 60 minutes after fluid challenge.
Diastolic heart function
Time frame: Immediately, 30 and 60 minutes after fluid challenge.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2025.
- Individual participant dataSharing planned: No
Related trials for Fluid Challenge
RecruitingObservational study
Role of End-Tidal CO2 During Passive Leg Raising to Predict Fluid Responsiveness in ICU
Circulatory Failure, Critical Illness
Not yet recruitingObservational study
Capillary Refill Time Variation to Predict Oxygen Comsumption Variation After FLuid Challenge (CARTOFL)
Critically Ill Patients, Circulatory Shock
Not yet recruitingObservational study
Fluid Responsiveness in Laparoscopic Surgery: End-Expiratory Occlusion Test Versus Mini-Fluid Challenge
Fluid Responsiveness, Laparoscopic Surgery
Not yet recruitingObservational study
Changes in Portal Vein Pulsatility Variability During a Tidal Volume Challenge Can Predict Fluid Tolerance
Venous Congestion
RecruitingObservational study
Respiratory Variation of Carotid Doppler Peak Velocity (CDPV) for Non-invasive Prediction of Fluid Responsiveness
Hemodynamic Instability
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Osama Abou-Arab, Dr principal investigator
CHU Amiens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fluid challenge in people with Fluid Challenge and Oxygen Consumption, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VO2 after fluid challenge (time frame: 30 minutes after fluid challenge.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2025.