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Diagnosis Accuracy of Hemoconcentration to Detect Hypovolemia During CRRT

Is Variation of Plasmatic Protein Concentration During Continuous Renal Replacement Therapy Predictive of Hypovolemia in Intensive Care Unit?

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03144349
Enrollment
52
Registered
2017-05-08
Start date
2016-12-31
Completion date
2019-12-31
Last updated
2019-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Continuous Renal Replacement Therapy, Fluid Overload, Hypovolemia, Intensive Care Unit

Brief summary

The aim of the study is to analyze if blood protein concentration variation during continuous renal replacement therapy (CRRT) with fluid removal can predict a decrease of 15 % of cardiac index in intensive care unit (ICU) patients. Blood protein concentration, clinical data describing hemodynamic status (providing data from Pulsion medical system PiCCO2 ® monitoring), including preload dependency evaluation with passive leg raising, are collected at different times: before initiation of fluid removal, and after the first episode of hypotension or one hour after initiation of fluid removal.

Detailed description

The aim of the study is to analyze if blood protein concentration variation during continuous renal replacement therapy (CRRT) with fluid removal can predict a decrease of 15 % of cardiac index in intensive care unit (ICU) patients. Blood protein concentration, clinical data describing hemodynamic status (providing data from Pulsion medical system PiCCO2 ® monitoring), including preload dependency evaluation with passive leg raising, are collected at different times: before initiation of fluid removal, and after the first episode of hypotension or one hour after initiation of fluid removal.

Interventions

None listed

Sponsors

Hopital Louis Pradel
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* up to 18 years old * continuous renal replacement therapy * Suspicion of fluid overload * Prescription of fluid removal by the intensivist * PICCO2 monitoring

Exclusion criteria

* pregnancy * intra abdominal hypertension * Moribund patient * Abdominal hypertension

Design outcomes

Primary

MeasureTime frameDescription
plasmatic protein concentration variation1 hourTwo sample of plasmatic protein before and after a fluid removal will be performed. The variation of the protein concentration (computed as the difference between final and baseline value divided by the baseline value expressed in %) will be the index test to diagnose a decrease of cardiac output of more than 15 % due to the fluid removal.

Secondary

MeasureTime frameDescription
Plasmatic protein concentration in patient with preload dependency before fluid removal1 hourhemoconcentration will be evaluated in the subgroup of preload dependent patients
Central venous pressure (CVP)1 hourCVP will be tested to evaluate the diagnostic ability to diagnose a reduction of cardiac output due the fluid removal
Global end diastolic volume (GEDV)1 hourGEDV, calculated with transpulmonary thermodilution will be tested to evaluate the diagnostic ability to diagnose a reduction of cardiac output due the fluid removal
Extravascular lung water (EVLW)1 hourEVLW, calculated with transpulmonary thermodilution will be tested to evaluate the diagnostic ability to diagnose a reduction of cardiac output due the fluid removal
hemoconcentration evaluated with hemoglobin variation1 hourhemoconcentration evaluated with hemoglobin variation will be tested to evaluate the diagnostic ability to diagnose a reduction of cardiac output due the fluid removal

Countries

France

Contacts

Primary ContactMatthias Jacquet-Lagèze, M.D., M.Sc.
matthias.jl@gmail.com+33 6 89 99 59
Backup ContactJean-Luc Fellahi, M.D.,Ph.D.
jean-luc.fellahi@chu-lyon.fr+334 72 11 89 42

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026