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?

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 Overview

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

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 Type: Observational
• Enrollment (Anticipated): 52

Contacts and Locations

• Study Contact: Name: Matthias Jacquet-Lagèze, M.D., M.Sc.; Phone Number: +33 6 89 99 59; Email: matthias.jl@gmail.com
• Study Contact Backup: Name: Jean-Luc Fellahi, M.D.,Ph.D.; Phone Number: +334 72 11 89 42; Email: jean-luc.fellahi@chu-lyon.fr

Study Locations

• France
  • Rhône
    • Lyon, Rhône, France, 69000
      • Not yet recruiting
      • Matthias Jacquet-Lagreze
      • Contact: Matthias Jacquet-Lagreze, MD
      • Principal Investigator: Matthias MD Jacquet-Lagreze, MD
  • Rhône Alpes
    • Lyon, Rhône Alpes, France, 69350
      • Recruiting
      • Hôpital Cardiologique Louis Pradel
      • Contact: Matthias Jacquet-Lagreze, M.D., M.Sc.; Phone Number: +33 6 89 10 99 59; Email: matthias.jl@gmail.com
      • Contact: Jean-Luc Fellahi, M.D.,Ph.D.; Phone Number: +33 4 72 11 89 42; Email: jean-luc.fellahi@chu-lyon.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
plasmatic protein concentration variation	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.	1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasmatic protein concentration in patient with preload dependency before fluid removal	hemoconcentration will be evaluated in the subgroup of preload dependent patients	1 hour
Central venous pressure (CVP)	CVP will be tested to evaluate the diagnostic ability to diagnose a reduction of cardiac output due the fluid removal	1 hour
Global end diastolic volume (GEDV)	GEDV, calculated with transpulmonary thermodilution will be tested to evaluate the diagnostic ability to diagnose a reduction of cardiac output due the fluid removal	1 hour
Extravascular lung water (EVLW)	EVLW, calculated with transpulmonary thermodilution will be tested to evaluate the diagnostic ability to diagnose a reduction of cardiac output due the fluid removal	1 hour
hemoconcentration evaluated with hemoglobin variation	hemoconcentration evaluated with hemoglobin variation will be tested to evaluate the diagnostic ability to diagnose a reduction of cardiac output due the fluid removal	1 hour

Collaborators and Investigators

• Sponsor: Hopital Louis Pradel
• Investigators: Study Director: Jean-Luc Fellahi, M.D.,Ph.D., Hopital Louis Pradel

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2016
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: December 26, 2016
• First Submitted That Met QC Criteria: May 4, 2017
• First Posted (Actual): May 8, 2017

Study Record Updates

• Last Update Posted (Actual): April 16, 2019
• Last Update Submitted That Met QC Criteria: April 11, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hypovolemia
• Other Study ID Numbers: 2016-A01830-51

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided