ShockFRINCT00894309
Validation of the Fluid Responsiveness Index in Critically Ill Patients
An observational study of Shock and Critically Ill, run by Bicetre Hospital at 5 sites in 4 countries.
Trial summary
Fluid therapy is an important part of the management of patients with hemodynamic instability in the intensive care unit. By increasing cardiac preload, it aims at elevating cardiac output (CO) and thus restoring hemodynamic conditions in patients who are preload responsive. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Shock, Critically Ill
- How many people
- 80 participants
- Where
- 5 sitesin 4 countries
- Study dates
- May 2009to not given
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with an acute circulatory failure
Who may be able to join
- Age ≥ 18 years
- Hospitalization in an intensive care unit
- Presence of an acute circulatory failure as defined by the presence of at least one clinical sign of inadequate global perfusion
- Decision by the attending physician to give fluids will not be taken upon criteria predefined by the study protocol but considers:
- systolic arterial pressure < 90 mmHg (or fall of systolic arterial pressure of more than 50 mmHg in known hypertensive patients)
- urinary flow < 0.5 ml/kg/hr than two hours
Show all 13Show fewer
- tachycardia ≥ 100 beats/min
- delayed capillary refill
- mottled skin
- high lactate
- CO (Cardiac Output) that is not considered adequate and
- low GEDV (Global EndDiastolic Volume)
- Monitoring by a PiCCO2™ device (Pulsion Medical Systems, Munich, Germany) already in place as part of the routine hemodynamic monitoring
Who cannot join
- Clinical evidence of pulmonary edema, hypervolemia or ELWI > 10 ml/kg
Trial locations and contacts
5 sites in 4 countries.
5 sites in 4 countries
Germany2 sites
Universitätsklinik Eppendorf
Hamburg
Daniel Reuter, MD, PhD, dreuter@uke.uni-hamburg.de
Klinikum Rechts der Isar
Munich
Wolfgang Huber, MD, PhD, wolfgg.huber@t-online.de
France1 site
Medical Intensive Care Unit
Le Kremlin-Bicêtre
Xavier Monnet, MD, PhD
Xavier Monnet, MD, PhD
Israel1 site
Department of Anesthesiology and Intensive Care Sheba Medical Centre
Tel Aviv
Azriel Perel, MD, PhD, +972526667200, perelao@shani.net
Spain1 site
Unidad de cuidados intensivos, Fundacion Jimenez Diaz
Madrid
Fernando Suarez Sipmann, MD, PhD, FSuarez@fjd.es
About this study
Official title: Evaluation of the Validity of a New Index Provided by the PiCCO2 Device for Predicting Fluid Responsiveness in Critically Ill Patients
Fluid therapy is an important part of the management of patients with hemodynamic instability in the intensive care unit. By increasing cardiac preload, it aims at elevating cardiac output (CO) and thus restoring hemodynamic conditions in patients who are preload responsive. By contrast, volume administration can be deleterious in terms of pulmonary edema formation or other manifestations or fluid overload, especially in patients who are not preload responsive. Functional dynamic parameters that use heart-lung interactions, such as pulse pressure variation (PPV) and stroke volume variation (SVV) are considered accurate predictors of preload responsiveness in patients receiving fully controlled mechanical ventilation.
However, in cases of spontaneous breathing activity where heart-lung interaction indices fail to predict fluid responsiveness, one needs parameters able to reliably predict the hemodynamic response of fluid administration.
Read more
A new index that could indicate fluid responsiveness, so-called the fluid responsiveness index (FRI), has been elaborated. The advantage is that it could be used in patients who are not in control mechanical ventilation as well as in patients who are fully adapted to mechanical ventilation.
The FRI is based upon the analysis of continuous arterial and continuous central venous pressure. The FRI is determined by the relation of cardiac and respiratory activity; both are evaluated by means of power spectrum analysis of the pressures recorded.
The aim of this study is to test the value of the FRI to predict the hemodynamic response to fluid infusion in patients with hemodynamic instability not receiving fully controlled mechanical ventilation.
- Conditions
- Shock, Critically Ill
- Medical subject headings
- Shock, Critical Illness
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2009 (estimated)
- Study startMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ShockStudies 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bicetre Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Xavier Monnet, MD, PhD, Principal investigator, Medical Intensive Care Unit - Bicêtre HospitalAzriel Perel, MD, PhD, Principal investigator, Department of Anesthesiology and Intensive Care Sheba Medical Centre Tel AvivJean-Louis Teboul, MD, PhD, Principal investigator, Medical Intensive Care Unit - Bicêtre HospitalDaniel Reuter, MD, PhD, Principal investigator, Universitätsklinik Eppendorf, HamburgWolfgang Huber, MD, PhD, Principal investigator, II. Med. Klinik, Station 2/11, MunichFernando Suarez Sipmann, MD, PhD, Principal investigator, Unidad de cuidados intensivos, Fundacion Jimenez Diaz, Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00894309
- Sponsor's protocol ID
- FRI-1
- Acronym
- FRI
- Status last verified
- May 2009
- First submitted
- 5 May 2009
- Last updated
- 6 May 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Validity of a New Index Provided by the PiCCO2 Device for Predicting Fluid Responsiveness in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT00894309
- Acronym / sponsor ID
- FRI / FRI-1
- Conditions
- Shock, Critically Ill
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Bicetre HospitalUniversity, hospital or other
- Study start
- May 2009
- First posted
- 6 May 2009 (estimated)
- 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.
Fluid therapy is an important part of the management of patients with hemodynamic instability in the intensive care unit. By increasing cardiac preload, it aims at elevating cardiac output (CO) and thus restoring hemodynamic conditions in patients who are preload responsive. By contrast, volume administration can be deleterious in terms of pulmonary edema formation or other manifestations or fluid overload, especially in patients who are not preload responsive. Functional dynamic parameters that use heart-lung interactions, such as pulse pressure variation (PPV) and stroke volume variation (SVV) are considered accurate predictors of preload responsiveness in patients receiving fully controlled mechanical ventilation.
However, in cases of spontaneous breathing activity where heart-lung interaction indices fail to predict fluid responsiveness, one needs parameters able to reliably predict the hemodynamic response of fluid administration.
A new index that could indicate fluid responsiveness, so-called the fluid responsiveness index (FRI), has been elaborated. The advantage is that it could be used in patients who are not in control mechanical ventilation as well as in patients who are fully adapted to mechanical ventilation.
The FRI is based upon the analysis of continuous arterial and continuous central venous pressure. The FRI is determined by the relation of cardiac and respiratory activity; both are evaluated by means of power spectrum analysis of the pressures recorded.
The aim of this study is to test the value of the FRI to predict the hemodynamic response to fluid infusion in patients with hemodynamic instability not receiving fully controlled mechanical ventilation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with an acute circulatory failure
Key inclusion criteria (13 listed)
- Age ≥ 18 years
- Hospitalization in an intensive care unit
- Presence of an acute circulatory failure as defined by the presence of at least one clinical sign of inadequate global perfusion
- Decision by the attending physician to give fluids will not be taken upon criteria predefined by the study protocol but considers:
- Monitoring by a PiCCO2™ device (Pulsion Medical Systems, Munich, Germany) already in place as part of the routine hemodynamic monitoring
Key exclusion criteria (1 listed)
- Clinical evidence of pulmonary edema, hypervolemia or ELWI > 10 ml/kg
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
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2009.
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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.
Xavier Monnet, MD, PhD principal investigator
Medical Intensive Care Unit - Bicêtre Hospital
Azriel Perel, MD, PhD principal investigator
Department of Anesthesiology and Intensive Care Sheba Medical Centre Tel Aviv
Jean-Louis Teboul, MD, PhD principal investigator
Medical Intensive Care Unit - Bicêtre Hospital
5 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Shock and Critically Ill, run by Bicetre Hospital at 5 sites in 4 countries.
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 13 inclusion and 1 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 6 May 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Germany, France, Israel, Spain. 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 Jean-Louis Teboul, MD, PhD (+33145213547, jean-louis.teboul@bct.aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
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 6 May 2009.