Septic ShockFC-RevNCT02116413
Does the Time Between the End of Vascular Filling and Evaluation of Its Effectiveness Modify Fluid Challenge Results in Septic Shock?
An observational study of Septic Shock, run by Centre Hospitalier Universitaire de Nīmes at 9 sites in France.
Trial summary
The main objective of this study is to evaluate in a population of patients with septic shock receiving 500 ml crystalloid over 10 minutes, the proportion of patients classified as "responders" to the fluid challenge (increase of at least 15% of ITV in aortic) at the end of vascular filling (T10) and becoming… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septic Shock
- What is being tested?
- Fluid challenge and Cardiac ultrasound
- Type of treatment
- Surgery or procedure
- How many people
- 145 participants
- Where
- 9 sitesFrance
- Study dates
- May 2014to 8 Jan 2016
- 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: The study population consists of patients admitted to intensive care, sedated and under controlled ventilatory support with septic shock criteria defined by severe sepsis associated with hypotension despite fluid resuscitation of 20-40 ml / kg and requiring vascular filling according to the following criteria: * oliguria <0.5 ml / kg / h for at least 2h * skin mottling * Arterial Lactate > 2 mmol / l * SvcO2 <70% or SvO2 <65% * Patient on noradrenaline. Severe sepsis is defined as a systemic inflammatory response associated with a suspected or proven infection and hypotension before filling, a lactate> 4 mmol / l or organ dysfunction.
Who may be able to join
- The patient has given his/hers consent or the patient is in an emergency situation (commitment to obtain the consent of the patient as soon as his/her condition permits)
- Patient affiliated or beneficiary of a health insurance plan
- Patient with septic shock: proven or suspected infection associated with hypotension or lactate> 4 mmol / l or organ dysfunction. Hypotension despite fluid resuscitation of 20 to -40 ml / kg.
- Patient under controlled mechanical ventilation
- Patient requiring vascular filling according to the following criteria:
- oliguria <0.5 ml / kg / h for at least 2h
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- skin mottling
- Arterial Lactate > 2 mmol / l
- SvcO2 <70% or SvO2 <65%
- Patient on noradrenaline.
Who cannot join
- The patient is has in another interventional study that might change the results of this study within the past 3 months
- The patient is under judicial protection, under tutorship or curatorship
- The patient refuses to sign the consent
- The patient is pregnant, parturient, or breastfeeding
- Valvular pathology: grade III and IV aortic or mitral insufficiency
- Non sinus electrocardiogram
Show all 9Show fewer
- Non-echogenic patient
- Patient with any spontaneous breathing
- Moribund patient
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
France9 sites
CHU d'Amiens - Hôpital Nord
Amiens, 80054
CHU de Besançon - Hôpital Jean Minjoz
Besançon, 25030
CHU de Caen - Hôpital Côte de Nacre
Caen, 14033
CHU de Clermont Ferrand - Hôpital Estaing
Clermont-Ferrand, 63003
CHU de Clermont Ferrand - Hôpital Gabriel-Montpied
Clermont-Ferrand, 63003
APHM - Hôpital Nord
Marseille, 13915
CHU de Nantes - Hôpital Guillaume et René Laennec
Nantes, 44093
CHU de Nice - Hôpital St-Roch
Nice, 06001
CHRU de Nîmes - Hôpital Universitaire Carémeau
Nîmes, 30029
About this study
The main objective of this study is to evaluate in a population of patients with septic shock receiving 500 ml crystalloid over 10 minutes, the proportion of patients classified as "responders" to the fluid challenge (increase of at least 15% of ITV in aortic) at the end of vascular filling (T10) and becoming "non-responders" 20 minutes after the end of the fluid challenge (T30) and whether this proportion is greater than 10 points.
Read the detailed description
The secondary objectives of this study are :
- To assess changes in different ultrasound parameters: E wave , E / A ratio , E / E ' in the event of vascular filling and construct a dose response curve for vascular filling.
- To determing a threshold value for the mitral E wave velcoity that can predict a positive response to volume expansion at T10 defined by a 15% increase in the sub aortic velocity time integral (ITV) after 500 ml of crystalloids in 10 minutes.
- To determine a threshold value for theITV at T0 that can predict a positive response to volume expansion at T10 defined by a 15% increase in the ITV after 500 ml of crystalloids in 10 minutes.
- To evaluate the proportion of responders at T10 becoming non-responders at T20.
- To evaluate the proportion of nonresponders at T10 and responders at T30 .
- To estimate the proportion of patients changing status regardless of the direction of change between T10 and T30 .
- Conditions
- Septic Shock
- Being tested
- Fluid challenge, Cardiac ultrasound
- Keywords
- fluid challenge, fluid resuscitation
- Medical subject headings
- Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluid challengeProcedure or surgery
The fluid challenge starts at minute 0 (T0) and consists of 500ml of crystalloids over 10 minutes.
Cardiac ultrasoundProcedure or surgery
Ultrasound measures are made at T0, T2, T4, T6, T8, T10, T20 and T30.
| Study group | Role | What they receive |
|---|---|---|
| The study population | The study population consists of patients admitted to intensive care, sedated and under controlled ventilatory support with septic shock criteria defined by severe sepsis associated with hypotension despite fluid resuscitation of 20-40 ml / kg and requiring vascular filling according to the following criteria:
oliguria <0.5 ml / kg / h for at least 2h skin mottling Arterial Lactate > 2 mmol / l SvcO2 <70% or SvO2 <65% Patient on noradrenaline.
Severe sepsis is defined as a systemic inflammatory response associated with a suspected or proven infection and hypotension before filling, a lactate> 4 mmol / l or organ dysfunction.
Intervention: Fluid challenge Intervention: Cardiac ultrasound Receives: Procedure: Fluid challenge; Procedure: Cardiac ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient status changes from "responder" at the end of the fluid challenge (T10) to "non-responder" 20 minutes after the end of the fluid challenge (T30).
Measured: 30 minutes
Secondary outcomes (30)
Mitral E wave
Measured: Baseline (minute 0)
Mitral E wave
Measured: 2 minutes
Mitral E wave
Measured: 4 minutes
Mitral E wave
Measured: 6 minutes
Mitral E wave
Measured: 8 minutes
Mitral E wave
Measured: 10 minutes
Mitral E wave
Measured: 20 minutes
Mitral E wave
Measured: 30 minutes
Mitral A wave
Measured: Baseline (minute 0)
Mitral A wave
Measured: 2 minutes
Mitral A wave
Measured: 4 minutes
Mitral A wave
Measured: 6 minutes
Mitral A wave
Measured: 8 minutes
Mitral A wave
Measured: 10 minutes
Mitral A wave
Measured: 20 minutes
Mitral A wave
Measured: 30 minutes
E' Wave at the lateral mitral annulus
Measured: Baseline (minute 0)
E' Wave at the lateral mitral annulus
Measured: 2 minutes
E' Wave at the lateral mitral annulus
Measured: 4 minutes
E' Wave at the lateral mitral annulus
Measured: 6 minutes
E' Wave at the lateral mitral annulus
Measured: 8 minutes
E' Wave at the lateral mitral annulus
Measured: 10 minutes
E' Wave at the lateral mitral annulus
Measured: 20 minutes
E' Wave at the lateral mitral annulus
Measured: 30 minutes
ITV
Measured: Baseline (minute 0)
ITV
Measured: 10 minutes
ITV
Measured: 20 minutes
ITV
Measured: 30 minutes
Patient status changes from "responder" at the end of the fluid challenge (T10) to "non-responder" 10 minutes after the end of the fluid challenge (T20).
Measured: 20 minutes
Patient status changes from "non-responder" at the end of the fluid challenge (T10) to "responder" 20 minutes after the end of the fluid challenge (T30).
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2014 (estimated)
- Study startMay 2014
- Primary completion8 Jan 2016
- Study completion8 Jan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- 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
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claire Roger, MD, Principal investigator, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02116413
- Sponsor's protocol ID
- LOCAL/2013/CR-01
- Other IDs
- 2013-A01702-43
- Acronym
- FC-Rev
- Status last verified
- Jan 2016
- First submitted
- 15 Apr 2014
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Roger C, Zieleskiewicz L, Demattei C, Lakhal K, Piton G, Louart B, Constantin JM, Chabanne R, Faure JS, Mahjoub Y, Desmeulles I, Quintard H, Lefrant JY, Muller L; AzuRea Group. Time course of fluid responsiveness in sepsis: the fluid challenge revisiting (FCREV) study. Crit Care. 2019 May 16;23(1):179. doi: 10.1186/s13054-019-2448-z.
PubMed 31097012
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does the Time Between the End of Vascular Filling and Evaluation of Its Effectiveness Modify Fluid Challenge Results in Septic Shock?
- ClinicalTrials.gov ID
- NCT02116413
- Acronym / sponsor ID
- FC-Rev / LOCAL/2013/CR-01
- Conditions
- Septic Shock
- Keywords
- fluid challenge, fluid resuscitation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- 8 Jan 2016 (actual)
- Study completion
- 8 Jan 2016 (actual)
- First posted
- 16 Apr 2014 (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.
The main objective of this study is to evaluate in a population of patients with septic shock receiving 500 ml crystalloid over 10 minutes, the proportion of patients classified as "responders" to the fluid challenge (increase of at least 15% of ITV in aortic) at the end of vascular filling (T10) and becoming "non-responders" 20 minutes after the end of the fluid challenge (T30) and whether this proportion is greater than 10 points.
Detailed description
The secondary objectives of this study are :
- To assess changes in different ultrasound parameters: E wave , E / A ratio , E / E ' in the event of vascular filling and construct a dose response curve for vascular filling.
- To determing a threshold value for the mitral E wave velcoity that can predict a positive response to volume expansion at T10 defined by a 15% increase in the sub aortic velocity time integral (ITV) after 500 ml of crystalloids in 10 minutes.
- To determine a threshold value for theITV at T0 that can predict a positive response to volume expansion at T10 defined by a 15% increase in the ITV after 500 ml of crystalloids in 10 minutes.
- To evaluate the proportion of responders at T10 becoming non-responders at T20.
- To evaluate the proportion of nonresponders at T10 and responders at T30 .
- To estimate the proportion of patients changing status regardless of the direction of change between T10 and T30 .
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The study population | – | Procedure: Fluid challenge, Procedure: Cardiac ultrasoundThe study population consists of patients admitted to intensive care, sedated and under controlled ventilatory support with septic shock criteria defined by severe sepsis associated with hypotension despite fluid resuscitation of 20-40 ml / kg and requiring vascular filling according to the following criteria: oliguria <0.5 ml / kg / h for at least 2h skin mottling Arterial Lactate > 2 mmol / l SvcO2 <70% or SvO2 <65% Patient on noradrenaline. Severe sepsis is defined as a systemic inflammatory response associated with a suspected or proven infection and hypotension before filling, a lactate> 4 mmol / l or organ dysfunction. Intervention: Fluid challenge Intervention: Cardiac ultrasound |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of patients admitted to intensive care, sedated and under controlled ventilatory support with septic shock criteria defined by severe sepsis associated with hypotension despite fluid resuscitation of 20-40 ml / kg and requiring vascular filling according to the following criteria: * oliguria <0.5 ml / kg / h for at least 2h * skin mottling * Arterial Lactate > 2 mmol / l * SvcO2 <70% or SvO2 <65% * Patient on noradrenaline. Severe sepsis is defined as a systemic inflammatory response associated with a suspected or proven infection and hypotension before filling, a lactate> 4 mmol / l or organ dysfunction.
Key inclusion criteria (10 listed)
- The patient has given his/hers consent or the patient is in an emergency situation (commitment to obtain the consent of the patient as soon as his/her condition permits)
- Patient affiliated or beneficiary of a health insurance plan
- Patient with septic shock: proven or suspected infection associated with hypotension or lactate> 4 mmol / l or organ dysfunction. Hypotension despite fluid resuscitation of 20 to -40 ml / kg.
- Patient under controlled mechanical ventilation
- Patient requiring vascular filling according to the following criteria:
Key exclusion criteria (9 listed)
- The patient is has in another interventional study that might change the results of this study within the past 3 months
- The patient is under judicial protection, under tutorship or curatorship
- The patient refuses to sign the consent
- The patient is pregnant, parturient, or breastfeeding
- Valvular pathology: grade III and IV aortic or mitral insufficiency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluid challengeThe fluid challenge starts at minute 0 (T0) and consists of 500ml of crystalloids over 10 minutes. | Procedure or surgery | The study population |
| Cardiac ultrasoundUltrasound measures are made at T0, T2, T4, T6, T8, T10, T20 and T30. | Procedure or surgery | The study population |
Primary outcome
Patient status changes from "responder" at the end of the fluid challenge (T10) to "non-responder" 20 minutes after the end of the fluid challenge (T30).
Time frame: 30 minutes
30 secondary outcomes
Mitral E wave
Time frame: Baseline (minute 0)
Mitral E wave
Time frame: 2 minutes
Mitral E wave
Time frame: 4 minutes
Mitral E wave
Time frame: 6 minutes
Mitral E wave
Time frame: 8 minutes
Mitral E wave
Time frame: 10 minutes
Mitral E wave
Time frame: 20 minutes
Mitral E wave
Time frame: 30 minutes
Mitral A wave
Time frame: Baseline (minute 0)
Mitral A wave
Time frame: 2 minutes
Mitral A wave
Time frame: 4 minutes
Mitral A wave
Time frame: 6 minutes
Mitral A wave
Time frame: 8 minutes
Mitral A wave
Time frame: 10 minutes
Mitral A wave
Time frame: 20 minutes
Mitral A wave
Time frame: 30 minutes
E' Wave at the lateral mitral annulus
Time frame: Baseline (minute 0)
E' Wave at the lateral mitral annulus
Time frame: 2 minutes
E' Wave at the lateral mitral annulus
Time frame: 4 minutes
E' Wave at the lateral mitral annulus
Time frame: 6 minutes
E' Wave at the lateral mitral annulus
Time frame: 8 minutes
E' Wave at the lateral mitral annulus
Time frame: 10 minutes
E' Wave at the lateral mitral annulus
Time frame: 20 minutes
E' Wave at the lateral mitral annulus
Time frame: 30 minutes
ITV
Time frame: Baseline (minute 0)
ITV
Time frame: 10 minutes
ITV
Time frame: 20 minutes
ITV
Time frame: 30 minutes
Patient status changes from "responder" at the end of the fluid challenge (T10) to "non-responder" 10 minutes after the end of the fluid challenge (T20).
Time frame: 20 minutes
Patient status changes from "non-responder" at the end of the fluid challenge (T10) to "responder" 20 minutes after the end of the fluid challenge (T30).
Time frame: 30 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
- Results publication: PubMed 31097012Roger C, Zieleskiewicz L, Demattei C, Lakhal K, Piton G, Louart B, Constantin JM, Chabanne R, Faure JS, Mahjoub Y, Desmeulles I, Quintard H, Lefrant JY, Muller L; AzuRea Group. Time course of fluid responsiveness in sepsis: the fluid challenge revisiting (FCREV) study. Crit Care. 2019 May 16;23(1):179. doi: 10.1186/s13054-019-2448-z.
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Sepsis
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.
Claire Roger, MD principal investigator
Centre Hospitalier Universitaire de Nīmes
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Septic Shock, run by Centre Hospitalier Universitaire de Nīmes at 9 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 10 inclusion and 9 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: finished, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient status changes from "responder" at the end of the fluid challenge (T10) to "non-responder" 20 minutes after the end of the fluid challenge (T30). (time frame: 30 minutes). 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 NCT02116413, which also lists 1 linked publication.
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 19 Nov 2025.