Diagnosis Accuracy of Hemoconcentration to Detect Hypovolemia During CRRT

• Conditions: Hypovolemia; Fluid Overload; Continuous Renal Replacement Therapy; Intensive Care Unit

• Registration Number: NCT03144349
• Lead Sponsor: Hopital Louis Pradel

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.

Study Timeline

• Study Start: 2016-12
• Study First Submitted: 2016-12-26
• Study First Submitted QC: 2017-05-04
• Study First Posted: 2017-05-08
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-11
• Last Update Posted: 2019-04-16
• Primary Completion: 2019-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 52

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
plasmatic protein concentration variation	1 hour	Two 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 Outcome Measures

Name	Time	Method
hemoconcentration evaluated with hemoglobin variation	1 hour	hemoconcentration evaluated with hemoglobin variation will be tested to evaluate the diagnostic ability to diagnose a reduction of cardiac output due the fluid removal
Plasmatic protein concentration in patient with preload dependency before fluid removal	1 hour	hemoconcentration will be evaluated in the subgroup of preload dependent patients
Central venous pressure (CVP)	1 hour	CVP 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 hour	GEDV, 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 hour	EVLW, calculated with transpulmonary thermodilution will be tested to evaluate the diagnostic ability to diagnose a reduction of cardiac output due the fluid removal

Trial Locations

Locations (2)

Hôpital Cardiologique Louis Pradel; 🇫🇷 Lyon, Rhône Alpes, France

Matthias Jacquet-Lagreze; 🇫🇷 Lyon, Rhône, France