Diagnosis Accuracy of Hemoconcentration to Detect Hypovolemia During CRRT

Intensive Care Unit Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03144349
• Other study ID #: 2016-A01830-51
• Status: Recruiting
• Start date: December 2016
• Est. completion date: December 2019

Study information

• Verified date: April 2019
• Source: Hopital Louis Pradel
• Contact: Matthias Jacquet-Lagèze, M.D., M.Sc.
• Phone: +33 6 89 99 59
• Email: matthias.jl[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 52
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
France	Hôpital Cardiologique Louis Pradel	Lyon	Rhône Alpes
France	Matthias Jacquet-Lagreze	Lyon	Rhône

Sponsors (1)

Lead Sponsor	Collaborator
Hopital Louis Pradel

Country where clinical trial is conducted

France, 

References & Publications (4)

Bitker L, Bayle F, Yonis H, Gobert F, Leray V, Taponnier R, Debord S, Stoian-Cividjian A, Guérin 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. — View 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. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Plasmatic protein concentration in patient with preload dependency before fluid removal	hemoconcentration will be evaluated in the subgroup of preload dependent patients	1 hour
Secondary	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
Secondary	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
Secondary	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
Secondary	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