Monitoring fluid content in septic shock patients
Assessment of Intra-thoracic Water by Bio Reactance During Stabilization and Therapeutic De-escalation in Septic Shock: A Prospective, Multicenter, Observational Study
University Hospital, Brest · NCT06572995
This study is testing a new way to monitor fluid levels in adult patients with septic shock to see if it can help doctors manage their treatment better in the ICU.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | University Hospital, Brest (other) |
| Locations | 2 sites (Brest and 1 other locations) |
| Trial ID | NCT06572995 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate thoracic fluid content in patients experiencing septic shock using a non-invasive bio reactance technology. The study focuses on the challenges of fluid overload during hemodynamic stabilization and therapeutic de-escalation in the ICU. By continuously monitoring fluid compartments at the bedside, the study seeks to provide valuable insights into managing fluid administration and removal, potentially improving patient outcomes. The research will involve adult patients who meet specific criteria related to septic shock and will be conducted at two locations in France.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old diagnosed with septic shock requiring vasopressors and expected to stay in the ICU for more than three days.
Not a fit: Patients who have been in the ICU for more than three days or those who are moribund or have opted for therapeutic withdrawal may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management of fluid therapy in septic shock patients, reducing morbidity and mortality associated with fluid overload.
How similar studies have performed: While the use of bio reactance technology is promising, this approach is relatively novel and has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult (Age \>18 years old) * Septic shock according to Sepsis-3 definition: * 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 * Predictive ICU length of stay \> 3 days Exclusion Criteria: * Admission in ICU for more than 3 days * Refusal to participate * Moribund patients * Decision of therapeutic withdrawal * Curators
Where this trial is running
Brest and 1 other locations
- Chu Brest — Brest, France (RECRUITING)
- Hegp - Aphp — Paris, France (NOT_YET_RECRUITING)
Study contacts
- Principal investigator: Xavier Chapalain, MD — University Hospital, Brest
- Study coordinator: Xavier Chapalain, MD
- Email: xavier.chapalain@chu-brest.fr
- Phone: +33230337893
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Sepsis, Septic Shock, Hemodynamic Instability, Fluid Overload