Clinical trial NCT03144349: Diagnosis Accuracy of Hemoconcentration to Detect Hypovolemia During CRRT
Official title: Is Variation of Plasmatic Protein Concentration During Continuous Renal Replacement Therapy Predictive of Hypovolemia in Intensive Care Unit?
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Continuous Renal Replacement Therapy
Intensive Care Unit
Hypovolemia
Fluid Overload
Lead sponsor: Hopital Louis Pradel
Sponsor class: OTHER
First posted: 2017-05-08
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have PiCCO2 ® monitoring and continuous renal replacement therapy with a prescription of fluid removal in 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.

Eligibility criteria: 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

Primary outcomes:
measure: plasmatic protein concentration variation
timeFrame: 1 hour
Secondary outcomes:
measure: Plasmatic protein concentration in patient with preload dependency before fluid removal
timeFrame: 1 hour
measure: Central venous pressure (CVP)
timeFrame: 1 hour
measure: Global end diastolic volume (GEDV)
timeFrame: 1 hour
measure: Extravascular lung water (EVLW)
timeFrame: 1 hour
measure: hemoconcentration evaluated with hemoglobin variation
timeFrame: 1 hour
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hôpital Cardiologique Louis Pradel
state: Rhône Alpes
city: Lyon
country: France
facility: Matthias Jacquet-Lagreze
state: Rhône
Study officials:
affiliation: Hopital Louis Pradel
name: Jean-Luc Fellahi, M.D.,Ph.D.
role: STUDY_DIRECTOR
References:
citation: Lamia B, Ochagavia A, Monnet X, Chemla D, Richard C, Teboul JL. Echocardiographic prediction of volume responsiveness in critically ill patients with spontaneously breathing activity. Intensive Care Med. 2007 Jul;33(7):1125-1132. doi: 10.1007/s00134-007-0646-7. Epub 2007 May 17.
citation: Monnet X, Marik P, Teboul JL. Passive leg raising for predicting fluid responsiveness: a systematic review and meta-analysis. Intensive Care Med. 2016 Dec;42(12):1935-1947. doi: 10.1007/s00134-015-4134-1. Epub 2016 Jan 29.
citation: Monnet X, Cipriani F, Camous L, Sentenac P, Dres M, Krastinova E, Anguel N, Richard C, Teboul JL. The passive leg raising test to guide fluid removal in critically ill patients. Ann Intensive Care. 2016 Dec;6(1):46. doi: 10.1186/s13613-016-0149-1. Epub 2016 May 20.
citation: Bitker L, Bayle F, Yonis H, Gobert F, Leray V, Taponnier R, Debord S, Stoian-Cividjian A, Guerin C, Richard JC. Prevalence and risk factors of hypotension associated with preload-dependence during intermittent hemodialysis in critically ill patients. Crit Care. 2016 Feb 23;20:44. doi: 10.1186/s13054-016-1227-3.