Intensive Care UnitsFOTOShockNCT04114162
Fluid Overload Quantification in Septic Shock
An observational study of Intensive Care Units and Shock, Septic, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial summary
Fluid management in septic shock patients remain a great challenge. Insufficient fluid filling lead to hypovolemia, organ failure and increased death, whereas fluid overload was associated to an increased morbidity and mortality in several studies. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Intensive Care Units, Shock, Septic
- How many people
- 64 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2020to 31 Dec 2023
- Phase
- Observational
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: ICU patient requiring fluid resuscitation for septic shock
Who may be able to join
- Patient aged from 18 to 80 years old
- Admitted to ICU for septic shock for less than 24 h
- Fluid resuscitation decided by intensivist
- Patient affiliated to a social security system or recipient of a such system
- Patient/proxy not opposed to the study
Who cannot join
- Subject with amputation of 1 or more limbs
- Body mass index > 35 kg.m-2 ou < 18 kg.m-2
- Impossibility of setting up an arterial catheter for invasive blood pressure monitoring and / or a central venous catheter in the upper cava territory
- Patient with pacemaker and / or implantable cardioverter defibrillator
- Quality of cardio echo image insufficient to allow studied parameters measurement
- Moribund subject ( life expectancy expected less than 48 hours)
Show all 12Show fewer
- Uncontrolled intracranial hypertension (intracranial pressure ≥ 20 mm Hg by ICP monitoring or by a pulsatility index ≥ 1.30 in the transcranial Doppler)
- Patient under ECMO/ECLS
- Legal incapacity or limited legal capacity
- Subject without health insurance
- Pregnant woman
- Subject being in the exclusion period of another study or provided for by the "National Volunteer File"
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Body Composition Monitor to Quantify Fluid Overload Related to Vascular Leak in Septic Shock Patients
Fluid management in septic shock patients remain a great challenge. Insufficient fluid filling lead to hypovolemia, organ failure and increased death, whereas fluid overload was associated to an increased morbidity and mortality in several studies.
Several invasive and non invasive strategies have been developed during the past years to monitor the hemodynamic state of septic shock patients, but no method has been validated to objectively quantify fluid overload in septic shock patients.
Read more
The Body Composition Monitor (BCM) allow for measurement of total body water (TBW), extracellular water (ECW) and intracellular water (ICW) volumes using bioimpedancemetry. The BCW is daily used in patients who undergo renal dialysis to assess the effectiveness of fluid removal. The BCM has never been validated in septic shock patients.
The aim of the study is to investigate the accuracy of the BCM to measure the variation of the TBW during a fluid challenge of 500 ml of saline during the early phase of septic shock.
Read the detailed description
Patients suffering from septic shock admitted in our critical care unit for less than 24 hours will be eligible. TBW, ECW and ICW volumes will be measured using the BCM just before (T0), just at the end (T1) and 1 h after the end (T2) of a fluid challenge of 500 ml of saline. Fluid responsiveness will be assessed using trans thoracic echocardiography (TTE). TTE will be performed at T0, T1 and T2. Blood samples will be obtained at T0, T1 and T2 to dose biomarkers of endothelial dysfunction and of capillary leak. The effectiveness of fluid challenge on microcirculation will be investigated by measuring the tissue perfusion index of the urethral mucosa using the IKORUS UP device.
Patients will be followed until Day 28 after admission in the critical care unit.
- Conditions
- Intensive Care Units, Shock, Septic
- Keywords
- ICU, Septic shock, Fluid overload, Quantification, Bioimpedancemetry, Capillary leak, Fluid responsiveness
- Medical subject headings
- Shock, Septic, Edema
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the accuracy of the BCM to measure the variation of the TBW volume during a fluid challenge.
The variation of the TBW volume measured by the BCM will be compared to the variation of the volume of fluids (fluid input minus fluid output) during a fluid challenge of 500 ml of saline. Fluid input will be the sum of the volume of all fluids and drugs delivered during the fluid challenge (including enteral nutrition). Fluid output will be the sum of all loss of fluid (surgical drain, urine output) during the fluid challenge.
Measured: 10 minutes
Secondary outcomes (11)
To describe the variation of the ECW volume measured by the BCM during a fluid challenge of 500 ml of saline.
The variation of the ECW volume during a fluid challenge of 500 ml of saline will be the difference between the ECW volume measured à T0 (just before the fluid challenge) and the ECW volume measured at T1 (just after the end of the fluid challenge).
Measured: 10 minutes
To describe the variation of the ECW volume on TBW volume ratio during a fluid challenge of 500 ml of saline.
ECW and TBW volumes will be measured using the BCM just before the fluid challenge (T0) and just after the end of the fluid challenge (T1). The ECW volume on TBW volume ratio (ECW/TBW ratio) will be calculated at T0 and at T1. The variation of the ECW/TBW ration will be the difference between the ECW/TBW ratio measured at T0 and the ECW/TBW ratio measured at T1.
Measured: 10 minutes
To compare the phase angle value measured at T0 by the BCM between responders and non responders at T1.
Fluid responsiveness at T1 will be defined by an increased of the stroke volume > 10% between T0 and T1. Stroke volume will be measured using trans thoracic echocardiography. The phase angle value at T0 will be compared between responders (patients with an increase of the stroke volume > 10%) and non responders.
Measured: 10 minutes
To describe the relationship between the phase angle value measured at T0 by the BCM and the capillary leak index.
The capillary leak index is defined by the following ratio: (blood C-reactive protein*100)/(blood albumin).
Measured: 10 minutes
To compare the ECW/TBW ratio at T0 between responders and non responders at T1.
Measured: 10 minutes
To compare the TBW volume at T0 between responders and non responders at T2.
Fluid responsiveness will be assessed at T2 (1 h after the end of the fluid challenge) using transthoracic echocardiography (TTE). Fluid responsiveness at T2 will be defined by an increased of the stroke volume > 10% compared to baseline (T0).
Measured: 70 minutes
To compare the ECW/TBW ratio at T0 between responders and non responders at T2.
Fluid responsiveness will be assessed at T2 (1 h after the end of the fluid challenge) using transthoracic echocardiography (TTE). Fluid responsiveness at T2 will be defined by an increased of the stroke volume > 10% compared to baseline (T0).
Measured: 70 minutes
To compare the ECW/TBW ratio at T2 between responders and non responders at T2.
Fluid responsiveness will be assessed at T2 (1 h after the end of the fluid challenge) using transthoracic echocardiography (TTE). Fluid responsiveness at T2 will be defined by an increased of the stroke volume > 10% compared to baseline (T0). ECW/TBW ratio will be calculated at T2 from the ECW and TBW volumes measured using the BCM at T2 (1 h after the end of fluid challenge).
Measured: 70 minutes
To describe the variation of the tissue perfusion index of the urethral mucosa (uPI) measured using the IKORUS UP device during the fluid challenge of 500 ml of saline.
The uPI will be continuously measured during the fluid challenge and until 1 hours after the end of the fluid challenge. The uPI will be measured using the IKORUS UP device.
Measured: 70 minutes
To describe the relationship between blood biomarkers of endothelial dysfunction and fluid responsiveness.
Blood biomarkers of endothelial dysfunction will be measured from blood samples obtained at T0, T1 and T2. Fluid responsiveness will be assessed using TTE. Fluid responsiveness will be defined by an increased of the stroke volume > 10% compared to baseline (T0).
Measured: 70 min
To describe the relationship between blood biomarkers of capillary leak and fluid responsiveness.
Blood biomarkers of capillary leak will be measured from blood samples obtained at T0, T1 and T2. Fluid responsiveness will be assessed using TTE. Fluid responsiveness will be defined by an increased of the stroke volume > 10% compared to baseline (T0).
Measured: 70 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2019
- Study start1 Jan 2020
- Primary completion30 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intensive Care UnitsStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Collaborators
- Don du Souffle de Besançon, Hopital Lariboisière
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04114162
- Sponsor's protocol ID
- P/2019/411
- Acronym
- FOTOShock
- Status last verified
- Jan 2025
- First submitted
- 1 Oct 2019
- Last updated
- 23 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Body Composition Monitor to Quantify Fluid Overload Related to Vascular Leak in Septic Shock Patients
- ClinicalTrials.gov ID
- NCT04114162
- Acronym / sponsor ID
- FOTOShock / P/2019/411
- Conditions
- Intensive Care Units, Shock, Septic
- Keywords
- ICU, Septic shock, Fluid overload, Quantification, Bioimpedancemetry, Capillary leak, Fluid responsiveness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Collaborators
- Don du Souffle de Besançon, Hopital Lariboisière
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 3 Oct 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.
Fluid management in septic shock patients remain a great challenge. Insufficient fluid filling lead to hypovolemia, organ failure and increased death, whereas fluid overload was associated to an increased morbidity and mortality in several studies.
Several invasive and non invasive strategies have been developed during the past years to monitor the hemodynamic state of septic shock patients, but no method has been validated to objectively quantify fluid overload in septic shock patients.
The Body Composition Monitor (BCM) allow for measurement of total body water (TBW), extracellular water (ECW) and intracellular water (ICW) volumes using bioimpedancemetry. The BCW is daily used in patients who undergo renal dialysis to assess the effectiveness of fluid removal. The BCM has never been validated in septic shock patients.
The aim of the study is to investigate the accuracy of the BCM to measure the variation of the TBW during a fluid challenge of 500 ml of saline during the early phase of septic shock.
Detailed description
Patients suffering from septic shock admitted in our critical care unit for less than 24 hours will be eligible. TBW, ECW and ICW volumes will be measured using the BCM just before (T0), just at the end (T1) and 1 h after the end (T2) of a fluid challenge of 500 ml of saline. Fluid responsiveness will be assessed using trans thoracic echocardiography (TTE). TTE will be performed at T0, T1 and T2. Blood samples will be obtained at T0, T1 and T2 to dose biomarkers of endothelial dysfunction and of capillary leak. The effectiveness of fluid challenge on microcirculation will be investigated by measuring the tissue perfusion index of the urethral mucosa using the IKORUS UP device.
Patients will be followed until Day 28 after admission in the critical care unit.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ICU patient requiring fluid resuscitation for septic shock
Key inclusion criteria (5 listed)
- Patient aged from 18 to 80 years old
- Admitted to ICU for septic shock for less than 24 h
- Fluid resuscitation decided by intensivist
- Patient affiliated to a social security system or recipient of a such system
- Patient/proxy not opposed to the study
Key exclusion criteria (12 listed)
- Subject with amputation of 1 or more limbs
- Body mass index > 35 kg.m-2 ou < 18 kg.m-2
- Impossibility of setting up an arterial catheter for invasive blood pressure monitoring and / or a central venous catheter in the upper cava territory
- Patient with pacemaker and / or implantable cardioverter defibrillator
- Quality of cardio echo image insufficient to allow studied parameters measurement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To assess the accuracy of the BCM to measure the variation of the TBW volume during a fluid challenge.
Time frame: 10 minutes
The variation of the TBW volume measured by the BCM will be compared to the variation of the volume of fluids (fluid input minus fluid output) during a fluid challenge of 500 ml of saline. Fluid input will be the sum of the volume of all fluids and drugs delivered during the fluid challenge (including enteral nutrition). Fluid output will be the sum of all loss of fluid (surgical drain, urine output) during the fluid challenge.
11 secondary outcomes
To describe the variation of the ECW volume measured by the BCM during a fluid challenge of 500 ml of saline.
Time frame: 10 minutes
To describe the variation of the ECW volume on TBW volume ratio during a fluid challenge of 500 ml of saline.
Time frame: 10 minutes
To compare the phase angle value measured at T0 by the BCM between responders and non responders at T1.
Time frame: 10 minutes
To describe the relationship between the phase angle value measured at T0 by the BCM and the capillary leak index.
Time frame: 10 minutes
To compare the ECW/TBW ratio at T0 between responders and non responders at T1.
Time frame: 10 minutes
To compare the TBW volume at T0 between responders and non responders at T2.
Time frame: 70 minutes
To compare the ECW/TBW ratio at T0 between responders and non responders at T2.
Time frame: 70 minutes
To compare the ECW/TBW ratio at T2 between responders and non responders at T2.
Time frame: 70 minutes
To describe the variation of the tissue perfusion index of the urethral mucosa (uPI) measured using the IKORUS UP device during the fluid challenge of 500 ml of saline.
Time frame: 70 minutes
To describe the relationship between blood biomarkers of endothelial dysfunction and fluid responsiveness.
Time frame: 70 min
To describe the relationship between blood biomarkers of capillary leak and fluid responsiveness.
Time frame: 70 minutes
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 23 Apr 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intensive Care Units and Shock, Septic, run by Centre Hospitalier Universitaire de Besancon 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 12 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 23 Apr 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?
To assess the accuracy of the BCM to measure the variation of the TBW volume during a fluid challenge. (time frame: 10 minutes). 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 23 Apr 2025.