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UnknownNCT05160467

Bio Electrical Impedance Analysis to Monitor Fluid Status During Deresuscitation Strategy in Continuous Renal Replacement Therapy

Bio Electrical Impedance Analysis to Monitor Fluid Status During Deresuscitation Strategy in Continuous Renal Replacement Therapy: a Proof of Concept Study

Status
Unknown
Phase
Study type
Observational
Enrollment
23 (estimated)
Sponsor
Hospices Civils de Lyon · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

Fluid overload is a poor prognostic factor in patients undergoing continuous renal replacement therapy in critical care. A strategy of active fluid removal by net ultrafiltration (UFnet) is one of the means to correct it. However, fluid overload is difficult to quantify: weight variations or cumulative fluid balance are easy to use but imprecise and not concordant markers, while reference methods such as isotope dilution are not adapted to daily practice. Bio electrical impedance analysis (BIA) is used to estimate body composition, including hydration. It is a non-invasive, rapid and painless measurement. It is commonly used in chronic intermittent haemodialysis to estimate dry weight and guide fluid removal, with a demonstrated impact on blood pressure control. This analysis is feasible in the ICU. Fluid overload as defined by BIA correlates with mortality, most notably in acute renal failure and during continuous renal replacement therapy. We routinely perform multifrequency segmental BIA (InBody S10, Seoul, Korea) in patients with fluid overload in our intensive care department. Since February 2021, we have implemented a protocol to systematically correct fluid overload by inducing negative fluid balance with UFnet in a manner appropriate to tissue perfusion. In this context, we systematically perform a BIA analysis on the day of the beginning of the fluid balance negativation and then every 48 hours during the first five days. We would like to evaluate the relevance of BIA monitoring in these patients by comparing it to other parameters of evaluation of the volume status usually used.

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTSegmental multi-frequency bio electrical impedance analysisA segmental (eight-polar) multi-frequency bio electrical impedance analysis (Inbody S10, Seoul, Korea) is carried out at the initiation of the deresuscitation strategy, at day 1, 3 and 5, in lying posture with touch type electrodes. Raw and derived parameters are recorded. The measurement is performed 5 times for the first measurement and then one time at day 1, 3 and 5. Measurement error is defined by the manufacturer as: reversed Impedance in different segment all between 5-500kHz; impedance over 50Ω in trunk, or over 700Ω in limb; sudden drop of impedance in trunk (more than 10Ω), or in limb (more than 50Ω). If it occurs, measurement is carried out three times maximum after solving potential technical issues to obtain a valid analysis.

Timeline

Start date
2021-03-15
Primary completion
2021-11-15
Completion
2022-01-01
First posted
2021-12-16
Last updated
2022-01-28

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT05160467. Inclusion in this directory is not an endorsement.