Thoracic Fluid Content During Stabilization and Therapeutic De-escalation in Septic Shock
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-99
SponsorUniversity Hospital, Brest
About this trial
In ICU, fluid challenge represents one of the cornerstones of hemodynamic care. However, fluid overload due to an excessive and/or inappropriate fluid administration could be associated with morbidity or mortality. Unfortunately, there is currently no continuous non-invasive devices to monitor fluid content at bedside. Bio reactance is a non-invasive, rapid and continuous technology developed in order to measure body fluid compartment. Monitoring devices functioning with such technology are promising to evaluate fluid overload in ICU.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult (Age >18 years old)
A suspected or confirmed infection
Persisting hypotension, despite adequate fluid resuscitation, requiring vasopressor to maintain a Mean Arterial Pressure (MAP) ≥ 65 mmHg
Lactate level > 2 mmol/l
Disqualifiers
Admission in ICU for more than 3 days
Refusal to participate
Moribund patients
Decision of therapeutic withdrawal
Trial population
Adult patients admitted in ICU for septic shock
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Changes in daily body weight
Evaluation of correlation between daily body weight and thoracic fluid content
Time frame
Daily, during the first 10 days2
Changes in extra vascular lung water
Evaluation of correlation between extra vascular lung water and thoracic fluid content
Time frame
Daily, during the first 10 days3
Changes in daily fluid balance
Evaluation of correlation between fluid balance and thoracic fluid content
Time frame
Daily, during the first 10 daysSecondary outcomes
1
Length of ICU stay
Number of day from admission to ICU leaving
Time frame
during ICU stay (up to 10 days)2
Length of hospital stay
Number of day from admission to hospital leaving
Time frame
during hospital stay (up to 10 days)3
Ventilator free days at Day 28
Number of day alive without mechanical from ICU admission to Day 28
Time frame
Day 284
Mortality at Day 28
Survival (Yes/No)
Time frame
Day 28Sponsors and contacts
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Source ClinicalTrials.gov