NCT04114162

Fluid Overload Quantification in Septic Shock

Body Composition Monitor to Quantify Fluid Overload Related to Vascular Leak in Septic Shock Patients

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 64 (actual)
• Sponsor: Centre Hospitalier Universitaire de Besancon · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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. 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.

Conditions

• Intensive Care Units
• Shock, Septic

Timeline

• Start date: 2020-01-01
• Primary completion: 2023-12-30
• Completion: 2023-12-31
• First posted: 2019-10-03
• Last updated: 2025-04-23

Locations

1 site across 1 country: France