Continuous Renal Replacement TherapyNCT03144349
Diagnosis Accuracy of Hemoconcentration to Detect Hypovolemia During CRRT
An observational study of Continuous Renal Replacement Therapy and Intensive Care Unit, run by Hopital Louis Pradel at 2 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Continuous Renal Replacement Therapy, Intensive Care Unit, Hypovolemia
- How many people
- 52 participants
- Where
- 2 sitesFrance
- Study dates
- Dec 2016to Dec 2019
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have PiCCO2 ® monitoring and continuous renal replacement therapy with a prescription of fluid removal in intensive care unit
Who may be able to join
- up to 18 years old
- continuous renal replacement therapy
- Suspicion of fluid overload
- Prescription of fluid removal by the intensivist
- PICCO2 monitoring
Who cannot join
- pregnancy
- intra abdominal hypertension
- Moribund patient
- Abdominal hypertension
Trial locations and contacts
2 sites in 1 country.
France2 sites, 2 recruiting
- Recruiting
Hôpital Cardiologique Louis Pradel
Lyon, Auvergne-Rhône-Alpes, 69350
Matthias Jacquet-Lagrèze, M.D., M.Sc., +33 6 89 10 99 59, matthias.jl@gmail.com
Jean-Luc Fellahi, M.D.,Ph.D., +33 4 72 11 89 42, jean-luc.fellahi@chu-lyon.fr
- Not yet recruiting
Matthias Jacquet-Lagreze
Lyon, Rhône, 69000
Matthias Jacquet-Lagreze, MD
Matthias MD Jacquet-Lagreze, MD
About this study
Official title: 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.
Read the 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.
- Medical subject headings
- Hypovolemia, Edema
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 hour
Secondary outcomes (5)
Plasmatic protein concentration in patient with preload dependency before fluid removal
hemoconcentration will be evaluated in the subgroup of preload dependent patients
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2017
- Study startDec 2016
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Continuous Renal Replacement TherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 52 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Hopital Louis Pradel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthias Jacquet-Lagrèze, Hopital Louis Pradel
- Investigators
- Jean-Luc Fellahi, M.D.,Ph.D., Study director, Hopital Louis Pradel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03144349
- Sponsor's protocol ID
- 2016-A01830-51
- Status last verified
- Apr 2019
- First submitted
- 26 Dec 2016
- Last updated
- 16 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
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.
PubMed 17508199Monnet 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.
PubMed 26825952Monnet 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.
PubMed 27207178Bitker 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.
PubMed 26907782
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Variation of Plasmatic Protein Concentration During Continuous Renal Replacement Therapy Predictive of Hypovolemia in Intensive Care Unit?
- ClinicalTrials.gov ID
- NCT03144349
- Acronym / sponsor ID
- 2016-A01830-51
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Hopital Louis PradelUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 8 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have PiCCO2 ® monitoring and continuous renal replacement therapy with a prescription of fluid removal in intensive care unit
Key inclusion criteria (5 listed)
- up to 18 years old
- continuous renal replacement therapy
- Suspicion of fluid overload
- Prescription of fluid removal by the intensivist
- PICCO2 monitoring
Key exclusion criteria (4 listed)
- pregnancy
- intra abdominal hypertension
- Moribund patient
- Abdominal hypertension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
plasmatic protein concentration variation
Time frame: 1 hour
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.
5 secondary outcomes
Plasmatic protein concentration in patient with preload dependency before fluid removal
Time frame: 1 hour
Central venous pressure (CVP)
Time frame: 1 hour
Global end diastolic volume (GEDV)
Time frame: 1 hour
Extravascular lung water (EVLW)
Time frame: 1 hour
hemoconcentration evaluated with hemoglobin variation
Time frame: 1 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2019.
- Background: PubMed 17508199Lamia 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.
- Background: PubMed 26825952Monnet 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.
- Background: PubMed 27207178Monnet 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.
- Background: PubMed 26907782Bitker 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Luc Fellahi, M.D.,Ph.D. study director
Hopital Louis Pradel
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Continuous Renal Replacement Therapy and Intensive Care Unit, run by Hopital Louis Pradel at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Matthias Jacquet-Lagèze, M.D., M.Sc. (+33 6 89 99 59, matthias.jl@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
plasmatic protein concentration variation (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03144349, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2019.