ShockIVT NonVentNCT01590511
Echocardiographic Prediction of Fluid Responsiveness After a Mini-fluid Challenge in Non-ventilated Patients With Shock
An observational study of Shock and Circulatory Failure, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
The main objective of this study is to show that the variation of the subaortic velocity time integral after a mini test by filling 100 cc of normal saline over 1 minute (ΔITV100) is predictive of response to filling (defined as an increase in aortic velocity time integral measured by transthoracic ultrasound over 15%… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shock, Circulatory Failure
- How many people
- 71 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2013to Dec 2015
- 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 in the emergency room or intensive care in acute circulatory failure without ventilatory support.
Who may be able to join
- The patient must have given his/her informed and signed consent
- The patient must be insured or beneficiary of a health insurance plan
- Systolic blood pressure (SBP) < 90 mmHg
- Signs of inadequate cardiac output: urine output <0.5 ml / kg / h for more than two hours, hyperlactataemia
- Requires amines to maintain an SBP ≥ 90 mmHg or inability to lower amines or requires an increase in amines
Who cannot join
- The patient is participating in another study
- The patient is in an exclusion period determined by a previous study
- The patient is under judicial protection, under tutorship or curatorship
- The patient (or his/her person-of-trust) refuses to sign the consent
- It is impossible to correctly inform the patient
- The patient is pregnant, parturient, or breastfeeding
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- The patients has a contraindication for a treatment necessary for this study
- Cardiogenic shock
- Acute pulmonary edema
- Moribund patient
- Non echogenic patient
- Patient with cardiac arrhythmia
- Patients for whom the passive leg raising test is contraindicated (hyper intra-abdominal pressure, pelvic or lower limb trauma)
Trial locations and contacts
1 site in 1 country.
About this study
The main objective of this study is to show that the variation of the subaortic velocity time integral after a mini test by filling 100 cc of normal saline over 1 minute (ΔITV100) is predictive of response to filling (defined as an increase in aortic velocity time integral measured by transthoracic ultrasound over 15% after administration of 500 cc of normal saline over 15 minutes) in non-ventilated shock patients.
Read the detailed description
The secondary objectives of this study include:
- To determine the sensitivity and specificity of the variation of the velocity time integral after administration of 100 cc of normal saline over 1 minute (ΔITV100) to predict the response to the filling.
- To study the inter-observer variation of ΔITV100 measurement.
- To compare ΔITV100 to other clinical and radiological parameters for predicting response to filling (initial value of the subaortic velocity time integral, variation in mitral E wave, E / A, respiratory variation of the diameter of the inferior vena cava, marbling clinical evolution score.
- Conditions
- Shock, Circulatory Failure
- Keywords
- mini fluid challenge, subaortic velocity time integral
- Medical subject headings
- Shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| The study population | Patients in the emergency room or intensive care in acute circulatory failure without ventilatory support. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the subaortic velocity time integral after 100cc of normal saline over 15 minutes (cm^2)
Measured: baseline; 26 minutes
Secondary outcomes (7)
Change if the subaortic velocity time integral after a passive leg raising trial (cm^2)
Measured: baseline; 15 minutes
Change in heart rate after the "mini-fluid challenge"
(bpm,%)
Measured: baseline; 26 minutes
Change in mean arterial pressure after the "mini-fluid challenge" (mmHg)
Measured: baseline; 26 minutes
Change in mitral E wave (cm / s) after the "mini-fluid challenge"
Measured: baseline; 26 minutes
Change in the E/A ratio after the "mini-fluid challenge"
Measured: baseline; 26 minutes
Change in the Marbrure clinical score after the "mini-fluid challenge"
Measured: baseline; 26 minutes
Change in lower vena cava diameter
(DiameterMax-DiameterMin) / DiameterMax (cm;%)
Measured: baseline; 8 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2012 (estimated)
- Study startJan 2013
- Primary completionDec 2015
- Study completionDec 2015
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.
- 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
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xavier Bobbia, MD, Principal investigator, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01590511
- Sponsor's protocol ID
- LOCAL/2012/XB-02
- Other IDs
- 2012-A00500-43
- Acronym
- IVT NonVent
- Status last verified
- Dec 2015
- First submitted
- 30 Apr 2012
- Last updated
- 4 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Echocardiographic Prediction of Fluid Responsiveness After a Mini-fluid Challenge in Non-ventilated Patients With Shock
- ClinicalTrials.gov ID
- NCT01590511
- Acronym / sponsor ID
- IVT NonVent / LOCAL/2012/XB-02
- Conditions
- Shock, Circulatory Failure
- Keywords
- mini fluid challenge, subaortic velocity time integral
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 3 May 2012 (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 show that the variation of the subaortic velocity time integral after a mini test by filling 100 cc of normal saline over 1 minute (ΔITV100) is predictive of response to filling (defined as an increase in aortic velocity time integral measured by transthoracic ultrasound over 15% after administration of 500 cc of normal saline over 15 minutes) in non-ventilated shock patients.
Detailed description
The secondary objectives of this study include:
- To determine the sensitivity and specificity of the variation of the velocity time integral after administration of 100 cc of normal saline over 1 minute (ΔITV100) to predict the response to the filling.
- To study the inter-observer variation of ΔITV100 measurement.
- To compare ΔITV100 to other clinical and radiological parameters for predicting response to filling (initial value of the subaortic velocity time integral, variation in mitral E wave, E / A, respiratory variation of the diameter of the inferior vena cava, marbling clinical evolution score.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The study population | – | –Patients in the emergency room or intensive care in acute circulatory failure without ventilatory support. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients in the emergency room or intensive care in acute circulatory failure without ventilatory support.
Key inclusion criteria (5 listed)
- The patient must have given his/her informed and signed consent
- The patient must be insured or beneficiary of a health insurance plan
- Systolic blood pressure (SBP) < 90 mmHg
- Signs of inadequate cardiac output: urine output <0.5 ml / kg / h for more than two hours, hyperlactataemia
- Requires amines to maintain an SBP ≥ 90 mmHg or inability to lower amines or requires an increase in amines
Key exclusion criteria (13 listed)
- The patient is participating in another study
- The patient is in an exclusion period determined by a previous study
- The patient is under judicial protection, under tutorship or curatorship
- The patient (or his/her person-of-trust) refuses to sign the consent
- It is impossible to correctly inform the patient
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
Change in the subaortic velocity time integral after 100cc of normal saline over 15 minutes (cm^2)
Time frame: baseline; 26 minutes
7 secondary outcomes
Change if the subaortic velocity time integral after a passive leg raising trial (cm^2)
Time frame: baseline; 15 minutes
Change in heart rate after the "mini-fluid challenge"
Time frame: baseline; 26 minutes
Change in mean arterial pressure after the "mini-fluid challenge" (mmHg)
Time frame: baseline; 26 minutes
Change in mitral E wave (cm / s) after the "mini-fluid challenge"
Time frame: baseline; 26 minutes
Change in the E/A ratio after the "mini-fluid challenge"
Time frame: baseline; 26 minutes
Change in the Marbrure clinical score after the "mini-fluid challenge"
Time frame: baseline; 26 minutes
Change in lower vena cava diameter
Time frame: baseline; 8 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 4 Dec 2015.
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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 Bobbia, MD principal investigator
Centre Hospitalier Universitaire de Nīmes
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 Shock and Circulatory Failure, run by Centre Hospitalier Universitaire de Nīmes 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 5 inclusion and 13 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 4 Dec 2015. 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?
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?
Change in the subaortic velocity time integral after 100cc of normal saline over 15 minutes (cm^2) (time frame: baseline; 26 minutes). It is what the study was designed to measure, not a finding.
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 4 Dec 2015.