Diagnosis Accuracy of Hemoconcentration to Detect Hypovolemia During CRRT

NCT ID: NCT03144349

Last Updated: 2019-04-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

52 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-12-31

Study Completion Date

2019-12-31

Brief Summary

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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

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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.

Conditions

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Continuous Renal Replacement Therapy Intensive Care Unit Hypovolemia Fluid Overload

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hopital Louis Pradel

OTHER

Sponsor Role lead

Responsible Party

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Matthias Jacquet-Lagrèze

Medical Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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

Role: STUDY_DIRECTOR

Hopital Louis Pradel

Locations

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Hôpital Cardiologique Louis Pradel

Lyon, Auvergne-Rhône-Alpes, France

Site Status RECRUITING

Matthias Jacquet-Lagreze

Lyon, Rhône, France

Site Status NOT_YET_RECRUITING

Countries

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France

Central Contacts

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Matthias Jacquet-Lagèze, M.D., M.Sc.

Role: CONTACT

+33 6 89 99 59

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

Role: CONTACT

+334 72 11 89 42

Facility Contacts

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Matthias Jacquet-Lagrèze, M.D., M.Sc.

Role: primary

+33 6 89 10 99 59

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

Role: backup

+33 4 72 11 89 42

Matthias Jacquet-Lagreze, MD

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 17508199 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26825952 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27207178 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26907782 (View on PubMed)

Other Identifiers

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2016-A01830-51

Identifier Type: -

Identifier Source: org_study_id

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