Cardiovascular ShockNCT03753672
Central Venous Pressure (CVP) Changes do Not Predict Preload Unresponsiveness
An observational study of Cardiovascular Shock, run by Hopital Antoine Beclere at 1 site in France.
Trial summary
Passive leg raising (PLR) is routinely used to predict preload responsiveness in critically ill patients. However, real-time measurements of cardiac output are required to assess its effects. Some authors have suggested that in fluid non-responders, central venous pressure (CVP) increased markedly. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiovascular Shock
- What is being tested?
- preload responsiveness
- How many people
- 45 participants
- Where
- 1 siteFrance
- Study dates
- 10 Dec 2017to Jun 2019
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Critically ill patients with a central venous catheter in place and for whom the physician decided to test preload responsiveness by PLR were prospectively included. Transthoracic echocardiography was performed to obtain VTI. The CVP and VTI were measured before and during PLR.
Who may be able to join
- ADULTS
- Patients presenting with shock or other signs of circulatory failure (tachycardia, oliguria)
- Need for the physician to test preload responsiveness
- Patients already equipped by a central venous catheter for the measurement of CVP
Who cannot join
- patients<18 years old
- pregnancy
- instaility justifying rapid increase in cathecolamines
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hamzaoui Olfa
Clamart, 92141
OLFA HAMZAOUI, MD, 0033145374957, olfa.hamzaoui@abc.aphp.fr
About this study
Passive leg raising (PLR) is routinely used to predict preload responsiveness in critically ill patients. However, real-time measurements of cardiac output are required to assess its effects. Some authors have suggested that in fluid non-responders, central venous pressure (CVP) increased markedly. By analogy with the CVP rules proposed by Weill et al to assess a fluid challenge, it has been hypothesized that an increase in CVP ≥ 5 mmHg during PLR can predict preload unresponsiveness.
Objective Investigation of whether an increase in CVP ≥ 5 mmHg during PLR predict preload unresponsiveness diagnosed by the absence of increase in velocity-time integral (VTI) of the flow in the left ventricular outflow tract by more than 10% (4).
Methods Critically ill patients with a central venous catheter in place and for whom the physician decided to test preload responsiveness by PLR were prospectively included. Transthoracic echocardiography was performed to obtain VTI. The CVP and VTI were measured before and during PLR.
- Conditions
- Cardiovascular Shock
- Being tested
- preload responsiveness
- Medical subject headings
- Shock, Cardiogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
preload responsivenessDiagnostic test
We investigated whether an increase in CVP ≥ 5 mmHg during PLR predict preload unresponsiveness diagnosed by the absence of increase in velocity-time integral (VTI) of the flow in the left ventricular outflow tract by more than 10%
| Study group | Role | What they receive |
|---|---|---|
| preload responsive | defined as an increase in Velocity time integral of the sub-aortic flow greater or equal to 10% Receives: Diagnostic Test: preload responsiveness | |
| preload unresponsive | defined as an increase in Velocity time integral of the sub-aortic flow lower than 10% Receives: Diagnostic Test: preload responsiveness |
What is being measured
The primary outcome is the main question the study is designed to answer.
the predictive value of changes in CVP to determine preload responsiveness
Systolic, diastolic and mean arterial pressure will be assessed before and after the PLR test
Measured: ONE MINUTE TEST
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2018
- Study start10 Dec 2017
- Primary completionMar 2019 (estimated)
- Study completionJun 2019 (estimated)
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 Cardiovascular 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
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hopital Antoine Beclere
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hamzaoui Olfa, Hopital Antoine Beclere
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03753672
- Sponsor's protocol ID
- 2017-A03578-45
- Status last verified
- Feb 2019
- First submitted
- 19 Nov 2018
- Last updated
- 22 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hamzaoui O, Gouezel C, Jozwiak M, Millereux M, Sztrymf B, Prat D, Jacobs F, Monnet X, Trouiller P, Teboul JL. Increase in Central Venous Pressure During Passive Leg Raising Cannot Detect Preload Unresponsiveness. Crit Care Med. 2020 Aug;48(8):e684-e689. doi: 10.1097/CCM.0000000000004414.
PubMed 32697509
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Central Venous Pressure (CVP) Changes do Not Predict Preload Unresponsiveness
- ClinicalTrials.gov ID
- NCT03753672
- Acronym / sponsor ID
- 2017-A03578-45
- Conditions
- Cardiovascular Shock
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Hopital Antoine BeclereUniversity, hospital or other
- Study start
- 10 Dec 2017 (actual)
- Primary completion
- Mar 2019 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 27 Nov 2018 (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.
Passive leg raising (PLR) is routinely used to predict preload responsiveness in critically ill patients. However, real-time measurements of cardiac output are required to assess its effects. Some authors have suggested that in fluid non-responders, central venous pressure (CVP) increased markedly. By analogy with the CVP rules proposed by Weill et al to assess a fluid challenge, it has been hypothesized that an increase in CVP ≥ 5 mmHg during PLR can predict preload unresponsiveness.
Objective Investigation of whether an increase in CVP ≥ 5 mmHg during PLR predict preload unresponsiveness diagnosed by the absence of increase in velocity-time integral (VTI) of the flow in the left ventricular outflow tract by more than 10% (4).
Methods Critically ill patients with a central venous catheter in place and for whom the physician decided to test preload responsiveness by PLR were prospectively included. Transthoracic echocardiography was performed to obtain VTI. The CVP and VTI were measured before and during PLR.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| preload responsive | – | Diagnostic Test: preload responsivenessdefined as an increase in Velocity time integral of the sub-aortic flow greater or equal to 10% |
| preload unresponsive | – | Diagnostic Test: preload responsivenessdefined as an increase in Velocity time integral of the sub-aortic flow lower than 10% |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Critically ill patients with a central venous catheter in place and for whom the physician decided to test preload responsiveness by PLR were prospectively included. Transthoracic echocardiography was performed to obtain VTI. The CVP and VTI were measured before and during PLR.
Key inclusion criteria (4 listed)
- ADULTS
- Patients presenting with shock or other signs of circulatory failure (tachycardia, oliguria)
- Need for the physician to test preload responsiveness
- Patients already equipped by a central venous catheter for the measurement of CVP
Key exclusion criteria (3 listed)
- patients<18 years old
- pregnancy
- instaility justifying rapid increase in cathecolamines
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 |
|---|---|---|
| preload responsivenessWe investigated whether an increase in CVP ≥ 5 mmHg during PLR predict preload unresponsiveness diagnosed by the absence of increase in velocity-time integral (VTI) of the flow in the left ventricular outflow tract by more than 10% | Diagnostic test | preload responsive, preload unresponsive |
Primary outcome
the predictive value of changes in CVP to determine preload responsiveness
Time frame: ONE MINUTE TEST
Systolic, diastolic and mean arterial pressure will be assessed before and after the PLR test
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2019.
- Derived from this study: PubMed 32697509Hamzaoui O, Gouezel C, Jozwiak M, Millereux M, Sztrymf B, Prat D, Jacobs F, Monnet X, Trouiller P, Teboul JL. Increase in Central Venous Pressure During Passive Leg Raising Cannot Detect Preload Unresponsiveness. Crit Care Med. 2020 Aug;48(8):e684-e689. doi: 10.1097/CCM.0000000000004414.
- Individual participant dataSharing planned: Undecided
Related trials for Cardiovascular Shock
Recruiting
INitiation and Titration of Guideline Directed Medical TheRApy in HearT Failure Cardiogenic Shock With ImpElla 5.5 for Cardiac Recovery
Heart Failure, Cardiogenic Shock
Recruiting
COMPARE-VENT Feasibility Pilot Study
Respiration Failure, Cardio Vascular Disease
Not yet recruitingObservational study
Cardiovascular Phenotypes in Sepsis
Sepsis, Septic Shock
Enrolling by invitation
Advancing Health Information Exchange (HIE) During Inter-hospital Transfer (IHT) to Improve Patient Outcomes
Infections, Heart Failure
RecruitingObservational study
The Impact of Propofol and Ketamine on Cardiovascular Collapse During Induction for Intubation
Cardiovascular Collapse, Intubation Complication
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Shock, run by Hopital Antoine Beclere at 1 site 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 4 inclusion and 3 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 22 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the predictive value of changes in CVP to determine preload responsiveness (time frame: ONE MINUTE TEST). 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 NCT03753672, 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 22 Feb 2019; AzTrials last refreshed its copy on 30 Oct 2026.