Fluid Overload Quantification in Septic Shock

NCT04114162 | Completed DMC

• 1 other identifier: P/2019/411
• Study Type: observational
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Intensive Care Units; Shock, Septic

Keywords

ICU; Septic shock; Fluid overload; Quantification; Bioimpedancemetry; Capillary leak; Fluid responsiveness

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  10 minutes

• To describe the variation of the ECW volume on TBW volume ratio during a fluid challenge of 500 ml of saline.

  10 minutes

• To compare the phase angle value measured at T0 by the BCM between responders and non responders at T1.

  10 minutes

• To describe the relationship between the phase angle value measured at T0 by the BCM and the capillary leak index.

  10 minutes

• To compare the ECW/TBW ratio at T0 between responders and non responders at T1.

  10 minutes

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

ICU patient requiring fluid resuscitation for septic shock

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead
• Don du Souffle de Besançon: collaborator
• Hopital Lariboisière: collaborator

Study Sites (1)

Centre Hospitalier Universitaire de Besançon

Besançon, 25030, France

Location

MeSH Terms

Conditions

Shock, Septic; Edema

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2019
• First Posted: October 3, 2019
• Study Start: January 1, 2020
• Primary Completion: December 30, 2023
• Study Completion: December 31, 2023
• Last Updated: April 23, 2025

Record last verified: 2025-01

Locations

FR (1)