NCT03144349

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
52

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2016

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2016

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

December 26, 2016

Completed
4 months until next milestone

First Posted

Study publicly available on registry

May 8, 2017

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

April 16, 2019

Status Verified

April 1, 2019

Enrollment Period

3 years

First QC Date

December 26, 2016

Last Update Submit

April 11, 2019

Conditions

Continuous Renal Replacement TherapyIntensive Care UnitHypovolemiaFluid Overload

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Plasmatic protein concentration in patient with preload dependency before fluid removal

    1 hour

  • Central venous pressure (CVP)

    1 hour

  • Global end diastolic volume (GEDV)

    1 hour

  • Extravascular lung water (EVLW)

    1 hour

  • hemoconcentration evaluated with hemoglobin variation

    1 hour

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who have PiCCO2 ® monitoring and continuous renal replacement therapy with a prescription of fluid removal in intensive care unit

You may qualify if:

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

You may not qualify if:

  • pregnancy
  • intra abdominal hypertension
  • Moribund patient
  • Abdominal hypertension

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hôpital Cardiologique Louis Pradel

Lyon, Auvergne-Rhône-Alpes, 69350, France

RECRUITING

Matthias Jacquet-Lagreze

Lyon, Rhône, 69000, France

NOT YET RECRUITING

Related Publications (4)

  • 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.

    PMID: 17508199BACKGROUND

  • 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.

    PMID: 26825952BACKGROUND

  • 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.

    PMID: 27207178BACKGROUND

  • 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.

    PMID: 26907782BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Ionogram Protidemia Hemogram

MeSH Terms

Conditions

HypovolemiaEdema

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Officials

  • Jean-Luc Fellahi, M.D.,Ph.D.

    Hopital Louis Pradel

    STUDY DIRECTOR

Central Study Contacts

Matthias Jacquet-Lagèze, M.D., M.Sc.

CONTACT

+33 6 89 99 59matthias.jl@gmail.com

Jean-Luc Fellahi, M.D.,Ph.D.

CONTACT

+334 72 11 89 42jean-luc.fellahi@chu-lyon.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

December 26, 2016

First Posted

May 8, 2017

Study Start

December 1, 2016

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

April 16, 2019

Record last verified: 2019-04

Locations

FR(2)