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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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)
* 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"
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To assess the accuracy of the BCM to measure the variation of the TBW volume during a fluid challenge.
Timeframe: 10 minutes
Trial details
NCT IDNCT04114162
SponsorCentre Hospitalier Universitaire de Besancon