Ventricular DysfunctionALTERVOLNCT01673230
Hemodynamic Indices Predictive of a Beneficial Response to Fluid Expansion in Case of Hemodynamic Failure After Cardiac Surgery With Altered Preoperative Ejection Fraction (LVEF≤45%)
A study testing cardiac surgery for ventricular dysfunction in people with Ventricular Dysfunction, run by Rennes University Hospital at 1 site in France.
Trial summary
Low Cardiac Output Syndrome occurs frequently after cardiac surgery, especially when pre-operative LVEF is altered (LVEF≤45%). The correction of hemodynamic failure requires adapted treatments: fluid expansion and/or inotropic or vasoactive drugs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventricular Dysfunction
- What is being tested?
- cardiac surgery for ventricular dysfunction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2012to Dec 2015
- Phase
- Interventional
- 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
Who may be able to join
- patients >18 years old in the immediate post-operative period after cardiac surgery
- ASA 1 - 3
- Pre-operative LVEF≤45%
- Sedated with Ramsay score: 6
- Mechanically ventilated with tidal volume at 8ml/kg, PEEP at 0mmHg, I/Eat 0,5
- With hemodynamic failure: SAP≤90mmHg and/or inotropic or vasoactive drug started in the operating room and/or clinical sign of shock and/or CI ≤2,3l/min/m2
- Affiliation to Health Insurance
- Consent form signed
Who cannot join
- Cardiac arrhythmia: frequent atrial or ventricular extra systoles, atrial fibrillation
- Intracardiac shunt
- Weight less than 50 kg
- History of central nervous system illness
- Pulmonary oedema (clinical and/or radiological and/or wedge pressure>18mmHg)
- Right ventricular failure suspected (CVP> wedge pressure) or diagnosed (trans thoracic and/or transesophageal echocardiography)
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- Acute kidney injury with oligoanuria
- Severe post operative bleeding (chest tubes volume of >200ml/h for 3 hours or more)
- Severe hypoxia (PaO2/FIO2< 100)
- Administrative control (patient under guardianship or curatorship)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hemodynamic Indices Predictive of a Beneficial Response to Fluid Expansion in Case of Hemodynamic Failure After Cardiac Surgery With Altered Preoperative Ejection Fraction (LVEF≤45%): Sensibility and Specificity of Respiratory Variations of Pulse Pressure (∆PP), Photoplethysmography (∆POP), Perfusion Index (PVI), Before and After Fluid Expansion.
Low Cardiac Output Syndrome occurs frequently after cardiac surgery, especially when pre-operative LVEF is altered (LVEF≤45%). The correction of hemodynamic failure requires adapted treatments: fluid expansion and/or inotropic or vasoactive drugs. Predictive indices of a response to fluid challenge may allow an earlier hemodynamic optimization, which has not been showed until now when LVEF is altered.
- Conditions
- Ventricular Dysfunction
- Being tested
- cardiac surgery for ventricular dysfunction
- Medical subject headings
- Ventricular Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cardiac surgery for ventricular dysfunctionProcedure or surgery
For each included patient during the immediate post operative period, hemodynamic variables will be recorded (continuous arterial pressure, ECG, photoplethysmographic curve, CVP, wedge pressure, respiratory pressure), at rest (proclive 45°), during fluid expansion (physiological saline).
| Study group | Role | What they receive |
|---|---|---|
| Ventricular dysfunction | Other | cardiac surgery for ventricular dysfunction Receives: Procedure: cardiac surgery for ventricular dysfunction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of ∆PP, ∆POP, PVI and Cardiac index (CI)
To assess the sensibility and specificity of ∆PP, ∆POP, PVI, after fluid expansion in case of hemodynamic failure in the immediate post-operative period after cardiac surgery, when pre-operative LVEF is altered.
Measured: 2 hours
Secondary outcomes (1)
Measure of Systolic, diastolic and mean arterial pressure (SAP, DAP, MAP), Central venous pressure (CVP) and wedge pressure.
Secondary objectives :
- Early optimization of hemodynamics after cardiac surgery,
- To determine optimal threshold for ∆PP, ∆POP and PVI,
- To compare dynamic (∆PP, ∆POP and PVI) with static (central venous pressure: CVP, wedge pressure) indices
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2012 (estimated)
- Study startSep 2012
- 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 Ventricular DysfunctionStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- patrick guinet, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01673230
- Sponsor's protocol ID
- 2012-A00364-39
- Other IDs
- LOC/12-01
- Acronym
- ALTERVOL
- Status last verified
- Mar 2016
- First submitted
- 22 Aug 2012
- Last updated
- 27 Dec 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemodynamic Indices Predictive of a Beneficial Response to Fluid Expansion in Case of Hemodynamic Failure After Cardiac Surgery With Altered Preoperative Ejection Fraction (LVEF≤45%): Sensibility and Specificity of Respiratory Variations of Pulse Pressure (∆PP), Photoplethysmography (∆POP), Perfusion Index (PVI), Before and After Fluid Expansion.
- ClinicalTrials.gov ID
- NCT01673230
- Acronym / sponsor ID
- ALTERVOL / 2012-A00364-39
- Conditions
- Ventricular Dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 27 Aug 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.
Low Cardiac Output Syndrome occurs frequently after cardiac surgery, especially when pre-operative LVEF is altered (LVEF≤45%). The correction of hemodynamic failure requires adapted treatments: fluid expansion and/or inotropic or vasoactive drugs. Predictive indices of a response to fluid challenge may allow an earlier hemodynamic optimization, which has not been showed until now when LVEF is altered.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ventricular dysfunction | Other | Procedure: cardiac surgery for ventricular dysfunctioncardiac surgery for ventricular dysfunction |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- patients >18 years old in the immediate post-operative period after cardiac surgery
- ASA 1 - 3
- Pre-operative LVEF≤45%
- Sedated with Ramsay score: 6
- Mechanically ventilated with tidal volume at 8ml/kg, PEEP at 0mmHg, I/Eat 0,5
Key exclusion criteria (10 listed)
- Cardiac arrhythmia: frequent atrial or ventricular extra systoles, atrial fibrillation
- Intracardiac shunt
- Weight less than 50 kg
- History of central nervous system illness
- Pulmonary oedema (clinical and/or radiological and/or wedge pressure>18mmHg)
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 |
|---|---|---|
| cardiac surgery for ventricular dysfunctionFor each included patient during the immediate post operative period, hemodynamic variables will be recorded (continuous arterial pressure, ECG, photoplethysmographic curve, CVP, wedge pressure, respiratory pressure), at rest (proclive 45°), during fluid expansion (physiological saline). | Procedure or surgery | Ventricular dysfunction |
Primary outcome
Measure of ∆PP, ∆POP, PVI and Cardiac index (CI)
Time frame: 2 hours
To assess the sensibility and specificity of ∆PP, ∆POP, PVI, after fluid expansion in case of hemodynamic failure in the immediate post-operative period after cardiac surgery, when pre-operative LVEF is altered.
1 secondary outcome
Measure of Systolic, diastolic and mean arterial pressure (SAP, DAP, MAP), Central venous pressure (CVP) and wedge pressure.
Time frame: 2 hours
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 27 Dec 2019.
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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.
patrick guinet principal investigator
Rennes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cardiac surgery for ventricular dysfunction in people with Ventricular Dysfunction, run by Rennes University Hospital 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 8 inclusion and 10 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 27 Dec 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?
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?
Measure of ∆PP, ∆POP, PVI and Cardiac index (CI) (time frame: 2 hours). 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 27 Dec 2019.