HemodynamicsNCT02441621
Prediction of Volume Responsiveness in Presence of Left Ventricular Diastolic Dysfunction
A study testing passive leg raising, premedication and intubation and mechanical ventilation in people with Hemodynamics, run by University Hospital Schleswig-Holstein at 1 site in Germany.
Trial summary
The ability of the global end-diastolic volume index (GEDVI), stroke volume variation (SVV) and pulse pressure variation (PPV) for prediction of fluid responsiveness in presence of left ventricular diastolic dysfunction is still unknown. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodynamics
- What is being tested?
- passive leg raising, premedication and intubation and mechanical ventilation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2015to Jun 2016
- 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 yrs of age
- Patients with a left ventricular ejection fraction ≥0.5
- Patients with left ventricular diastolic dysfunction.
Who cannot join
- Emergency procedures
- Right ventricular dysfunction
- Hemodynamic instability requiring pharmacologic Support
- Ongoing arrhythmia
- Intracardiac Shunts
- Severe mitral stenosis or insufficiency
- Aortic aneurysm > 4 cm
- Use of an artificial left ventricular assist device or intra - aortic balloon pump.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Ole Broch
Kiel, Schleswig-Holstein, 24105
Ole Broch, MD, +49 431-5972990, ole.broch@uksh.de
Jochen Renner, MD, +49 431-5972991, jochen.renner@uksh.de
About this study
Official title: Prediction of Fluid Responsiveness in Presence of Diastolic Dysfunction
The ability of the global end-diastolic volume index (GEDVI), stroke volume variation (SVV) and pulse pressure variation (PPV) for prediction of fluid responsiveness in presence of left ventricular diastolic dysfunction is still unknown. The aim of the present study was to challenge the predictive power of GEDVI, SVV and PPV in cardiac surgery patients undergoing aortic valve replacement.
Read the detailed description
All patients receive premedication with midazolam 7.5 mg p.o.. After induction of anesthesia with sufentanil (0.5 µg/kg) and propofol (1.5 mg/kg), orotracheal intubation is facilitated with rocuronium (0.6 mg/kg). Anesthesia is maintained with sufentanil (1 µg/kg/h) and propofol (3 mg/kg/h) and patients are ventilated with an oxygen/air mixture in volume-controlled mode, using a tidal volume of 8 ml/kg related to the ideal body weight. Positive end-expiratory pressure is set at 5 cmH2O. Continuous monitoring is performed including electrocardiogram, radial arterial pressure catheter and a central venous catheter in the right or left internal jugular vein. Before placement of a transpulmonary thermodilution catheter a transesophageal echocardiography (TOE) is performed. TOE is used to detect diastolic dysfunction of the left ventricle and to exclude right ventricular dysfunction. In presence of left ventricular dysfunction a transpulmonary thermodilution catheter is placed in the femoral artery and connected to a PiCCO2 monitor (PiCCO2, Pulsion Medical Systems, Munich, Germany). Additionally capnography, urine output, temperature (blood, bladder and nasopharyngeal), airway pressure, and pulse oximetry are recorded.
Before starting operation a passive leg raising is performed. The passive leg raising maneuver (PLR) involves a leg elevation up to 45° with the trunk in a horizontal position and was performed to induce hemodynamic effects by a volume challenge, turning unstressed blood volume to stressed volume proportional to body size. In case of an increase of stroke volume index (SVI) >15% during PLR, patients were defined as responders.
All patients were studied with no changes in anesthesia management. Measurements of SVI, GEDVI, SVV and PPV are performed before, during and after PLR. Thereafter, patients receive a fluid Bolus of 500 ml crystalloids. Again, measurements are performed before and after fluid replacement.
- Conditions
- Hemodynamics
- Being tested
- passive leg raising, premedication, intubation and mechanical ventilation, central venous catheter, arterial catheter
- Keywords
- fluid responsiveness, diastolic dysfunction, left ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
passive leg raisingOther
The passive leg raising maneuver (PLR) involves a leg elevation up to 45° with the trunk in a horizontal position and is performed to induce hemodynamic effects by a volume challenge, turning unstressed blood volume to stressed volume proportional to body size.
premedicationOther
patients receive premedication with midazolam 7.5 mg p.o.
intubation and mechanical ventilationOther
After induction of anesthesia with sufentanil (0.5 µg/kg) and propofol (1.5 mg/kg), orotracheal intubation is facilitated with rocuronium (0.6 mg/kg). Anesthesia is maintained with sufentanil (1 µg/kg/h) and propofol (3 mg/kg/h) and patients are ventilated with an oxygen/air mixture in volume-controlled mode, using a tidal volume of 8 ml/kg related to the ideal body weight. Positive end-expiratory pressure is set at 5 cmH2O.
central venous catheterOther
a central venous catheter in the right or left internal jugular vein.
arterial catheterOther
Continuous monitoring is performed including electrocardiogram, radial arterial pressure catheter
transesophageal echocardiographyOther
Before placement of a transpulmonary thermodilution catheter a transesophageal echocardiography (TOE) is performed. TOE is used to detect diastolic dysfunction of the left ventricle and to exclude right ventricular dysfunction.
transpulmonary thermodilution catheterOther
In presence of left ventricular dysfunction a transpulmonary thermodilution catheter is placed in the femoral artery and connected to a PiCCO2 monitor (PiCCO2, Pulsion Medical Systems, Munich, Germany).
| Study group | Role | What they receive |
|---|---|---|
| Passive leg raising | Other | Not described Receives: Other: passive leg raising |
| premedication | Other | Not described Receives: Other: premedication |
| intubation and mechanical ventilation | Other | Not described Receives: Other: intubation and mechanical ventilation |
| central venous catheter | Other | Not described Receives: Other: central venous catheter |
| arterial catheter | Other | Continuous monitoring is performed including electrocardiogram, radial arterial pressure catheter Receives: Other: arterial catheter |
| transesophageal echocardiography | Other | Not described Receives: Other: transesophageal echocardiography |
| transpulmonary thermodilution catheter | Other | Not described Receives: Other: transpulmonary thermodilution catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase in stroke volume index (SVI) >15%
In presence of an increase of SVI >15% during PLR and/or 500 ml crystalloids, patients are defined as responders.
Measured: Patients will be obtained until the end of the operation, an expected average of 5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2015 (estimated)
- Study startJun 2015
- Primary completionMay 2016 (estimated)
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for HemodynamicsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Schleswig-Holstein
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ole Broch, MD, University Hospital Schleswig-Holstein
- Investigators
- Ole Broch, MD, Principal investigator, Consultant anesthetist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02441621
- Sponsor's protocol ID
- AZ-139
- Status last verified
- May 2015
- First submitted
- 28 Apr 2015
- Last updated
- 12 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Rex S, Schalte G, Schroth S, de Waal EE, Metzelder S, Overbeck Y, Rossaint R, Buhre W. Limitations of arterial pulse pressure variation and left ventricular stroke volume variation in estimating cardiac pre-load during open heart surgery. Acta Anaesthesiol Scand. 2007 Oct;51(9):1258-67. doi: 10.1111/j.1399-6576.2007.01423.x. Epub 2007 Aug 20.
PubMed 17714575Hofer CK, Muller SM, Furrer L, Klaghofer R, Genoni M, Zollinger A. Stroke volume and pulse pressure variation for prediction of fluid responsiveness in patients undergoing off-pump coronary artery bypass grafting. Chest. 2005 Aug;128(2):848-54. doi: 10.1378/chest.128.2.848.
PubMed 16100177Marik PE, Cavallazzi R, Vasu T, Hirani A. Dynamic changes in arterial waveform derived variables and fluid responsiveness in mechanically ventilated patients: a systematic review of the literature. Crit Care Med. 2009 Sep;37(9):2642-7. doi: 10.1097/CCM.0b013e3181a590da.
PubMed 19602972Renner J, Gruenewald M, Brand P, Steinfath M, Scholz J, Lutter G, Bein B. Global end-diastolic volume as a variable of fluid responsiveness during acute changing loading conditions. J Cardiothorac Vasc Anesth. 2007 Oct;21(5):650-4. doi: 10.1053/j.jvca.2007.05.006. Epub 2007 Jul 16.
PubMed 17905268Monnet X, Rienzo M, Osman D, Anguel N, Richard C, Pinsky MR, Teboul JL. Passive leg raising predicts fluid responsiveness in the critically ill. Crit Care Med. 2006 May;34(5):1402-7. doi: 10.1097/01.CCM.0000215453.11735.06.
PubMed 16540963Osman D, Ridel C, Ray P, Monnet X, Anguel N, Richard C, Teboul JL. Cardiac filling pressures are not appropriate to predict hemodynamic response to volume challenge. Crit Care Med. 2007 Jan;35(1):64-8. doi: 10.1097/01.CCM.0000249851.94101.4F.
PubMed 17080001Mahjoub Y, Pila C, Friggeri A, Zogheib E, Lobjoie E, Tinturier F, Galy C, Slama M, Dupont H. Assessing fluid responsiveness in critically ill patients: False-positive pulse pressure variation is detected by Doppler echocardiographic evaluation of the right ventricle. Crit Care Med. 2009 Sep;37(9):2570-5. doi: 10.1097/CCM.0b013e3181a380a3.
PubMed 19623051Cioffi G, Mazzone C, Barbati G, Rossi A, Nistri S, Ognibeni F, Tarantini L, Di Lenarda A, Faggiano P, Pulignano G, Stefenelli C, de Simone G, Devereux RB. Combined circumferential and longitudinal left ventricular systolic dysfunction in patients with asymptomatic aortic stenosis. Echocardiography. 2015 Jul;32(7):1064-72. doi: 10.1111/echo.12825. Epub 2014 Nov 5.
PubMed 25370995Rader F, Sachdev E, Arsanjani R, Siegel RJ. Left ventricular hypertrophy in valvular aortic stenosis: mechanisms and clinical implications. Am J Med. 2015 Apr;128(4):344-52. doi: 10.1016/j.amjmed.2014.10.054. Epub 2014 Nov 25.
PubMed 25460869
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Fluid Responsiveness in Presence of Diastolic Dysfunction
- ClinicalTrials.gov ID
- NCT02441621
- Acronym / sponsor ID
- AZ-139
- Conditions
- Hemodynamics
- Keywords
- fluid responsiveness, diastolic dysfunction, left ventricular
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital Schleswig-HolsteinUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- May 2016 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 12 May 2015 (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 ability of the global end-diastolic volume index (GEDVI), stroke volume variation (SVV) and pulse pressure variation (PPV) for prediction of fluid responsiveness in presence of left ventricular diastolic dysfunction is still unknown. The aim of the present study was to challenge the predictive power of GEDVI, SVV and PPV in cardiac surgery patients undergoing aortic valve replacement.
Detailed description
All patients receive premedication with midazolam 7.5 mg p.o.. After induction of anesthesia with sufentanil (0.5 µg/kg) and propofol (1.5 mg/kg), orotracheal intubation is facilitated with rocuronium (0.6 mg/kg). Anesthesia is maintained with sufentanil (1 µg/kg/h) and propofol (3 mg/kg/h) and patients are ventilated with an oxygen/air mixture in volume-controlled mode, using a tidal volume of 8 ml/kg related to the ideal body weight. Positive end-expiratory pressure is set at 5 cmH2O. Continuous monitoring is performed including electrocardiogram, radial arterial pressure catheter and a central venous catheter in the right or left internal jugular vein. Before placement of a transpulmonary thermodilution catheter a transesophageal echocardiography (TOE) is performed. TOE is used to detect diastolic dysfunction of the left ventricle and to exclude right ventricular dysfunction. In presence of left ventricular dysfunction a transpulmonary thermodilution catheter is placed in the femoral artery and connected to a PiCCO2 monitor (PiCCO2, Pulsion Medical Systems, Munich, Germany). Additionally capnography, urine output, temperature (blood, bladder and nasopharyngeal), airway pressure, and pulse oximetry are recorded.
Before starting operation a passive leg raising is performed. The passive leg raising maneuver (PLR) involves a leg elevation up to 45° with the trunk in a horizontal position and was performed to induce hemodynamic effects by a volume challenge, turning unstressed blood volume to stressed volume proportional to body size. In case of an increase of stroke volume index (SVI) >15% during PLR, patients were defined as responders.
All patients were studied with no changes in anesthesia management. Measurements of SVI, GEDVI, SVV and PPV are performed before, during and after PLR. Thereafter, patients receive a fluid Bolus of 500 ml crystalloids. Again, measurements are performed before and after fluid replacement.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Passive leg raising | Other | Other: passive leg raising |
| premedication | Other | Other: premedication |
| intubation and mechanical ventilation | Other | Other: intubation and mechanical ventilation |
| central venous catheter | Other | Other: central venous catheter |
| arterial catheter | Other | Other: arterial catheterContinuous monitoring is performed including electrocardiogram, radial arterial pressure catheter |
| transesophageal echocardiography | Other | Other: transesophageal echocardiography |
| transpulmonary thermodilution catheter | Other | Other: transpulmonary thermodilution catheter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients > 18 yrs of age
- Patients with a left ventricular ejection fraction ≥0.5
- Patients with left ventricular diastolic dysfunction.
Key exclusion criteria (8 listed)
- Emergency procedures
- Right ventricular dysfunction
- Hemodynamic instability requiring pharmacologic Support
- Ongoing arrhythmia
- Intracardiac Shunts
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 |
|---|---|---|
| passive leg raisingThe passive leg raising maneuver (PLR) involves a leg elevation up to 45° with the trunk in a horizontal position and is performed to induce hemodynamic effects by a volume challenge, turning unstressed blood volume to stressed volume proportional to body size. | Other | Passive leg raising |
| premedicationpatients receive premedication with midazolam 7.5 mg p.o. | Other | premedication |
| intubation and mechanical ventilationAfter induction of anesthesia with sufentanil (0.5 µg/kg) and propofol (1.5 mg/kg), orotracheal intubation is facilitated with rocuronium (0.6 mg/kg). Anesthesia is maintained with sufentanil (1 µg/kg/h) and propofol (3 mg/kg/h) and patients are ventilated with an oxygen/air mixture in volume-controlled mode, using a tidal volume of 8 ml/kg related to the ideal body weight. Positive end-expiratory pressure is set at 5 cmH2O. | Other | intubation and mechanical ventilation |
| central venous cathetera central venous catheter in the right or left internal jugular vein. | Other | central venous catheter |
| arterial catheterContinuous monitoring is performed including electrocardiogram, radial arterial pressure catheter | Other | arterial catheter |
| transesophageal echocardiographyBefore placement of a transpulmonary thermodilution catheter a transesophageal echocardiography (TOE) is performed. TOE is used to detect diastolic dysfunction of the left ventricle and to exclude right ventricular dysfunction. | Other | transesophageal echocardiography |
| transpulmonary thermodilution catheterIn presence of left ventricular dysfunction a transpulmonary thermodilution catheter is placed in the femoral artery and connected to a PiCCO2 monitor (PiCCO2, Pulsion Medical Systems, Munich, Germany). | Other | transpulmonary thermodilution catheter |
Primary outcome
Increase in stroke volume index (SVI) >15%
Time frame: Patients will be obtained until the end of the operation, an expected average of 5 hours
In presence of an increase of SVI >15% during PLR and/or 500 ml crystalloids, patients are defined as responders.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2015.
- Background: PubMed 17714575Rex S, Schalte G, Schroth S, de Waal EE, Metzelder S, Overbeck Y, Rossaint R, Buhre W. Limitations of arterial pulse pressure variation and left ventricular stroke volume variation in estimating cardiac pre-load during open heart surgery. Acta Anaesthesiol Scand. 2007 Oct;51(9):1258-67. doi: 10.1111/j.1399-6576.2007.01423.x. Epub 2007 Aug 20.
- Background: PubMed 16100177Hofer CK, Muller SM, Furrer L, Klaghofer R, Genoni M, Zollinger A. Stroke volume and pulse pressure variation for prediction of fluid responsiveness in patients undergoing off-pump coronary artery bypass grafting. Chest. 2005 Aug;128(2):848-54. doi: 10.1378/chest.128.2.848.
- Background: PubMed 19602972Marik PE, Cavallazzi R, Vasu T, Hirani A. Dynamic changes in arterial waveform derived variables and fluid responsiveness in mechanically ventilated patients: a systematic review of the literature. Crit Care Med. 2009 Sep;37(9):2642-7. doi: 10.1097/CCM.0b013e3181a590da.
- Background: PubMed 17905268Renner J, Gruenewald M, Brand P, Steinfath M, Scholz J, Lutter G, Bein B. Global end-diastolic volume as a variable of fluid responsiveness during acute changing loading conditions. J Cardiothorac Vasc Anesth. 2007 Oct;21(5):650-4. doi: 10.1053/j.jvca.2007.05.006. Epub 2007 Jul 16.
- Background: PubMed 16540963Monnet X, Rienzo M, Osman D, Anguel N, Richard C, Pinsky MR, Teboul JL. Passive leg raising predicts fluid responsiveness in the critically ill. Crit Care Med. 2006 May;34(5):1402-7. doi: 10.1097/01.CCM.0000215453.11735.06.
- Background: PubMed 17080001Osman D, Ridel C, Ray P, Monnet X, Anguel N, Richard C, Teboul JL. Cardiac filling pressures are not appropriate to predict hemodynamic response to volume challenge. Crit Care Med. 2007 Jan;35(1):64-8. doi: 10.1097/01.CCM.0000249851.94101.4F.
- Background: PubMed 19623051Mahjoub Y, Pila C, Friggeri A, Zogheib E, Lobjoie E, Tinturier F, Galy C, Slama M, Dupont H. Assessing fluid responsiveness in critically ill patients: False-positive pulse pressure variation is detected by Doppler echocardiographic evaluation of the right ventricle. Crit Care Med. 2009 Sep;37(9):2570-5. doi: 10.1097/CCM.0b013e3181a380a3.
- Background: PubMed 25370995Cioffi G, Mazzone C, Barbati G, Rossi A, Nistri S, Ognibeni F, Tarantini L, Di Lenarda A, Faggiano P, Pulignano G, Stefenelli C, de Simone G, Devereux RB. Combined circumferential and longitudinal left ventricular systolic dysfunction in patients with asymptomatic aortic stenosis. Echocardiography. 2015 Jul;32(7):1064-72. doi: 10.1111/echo.12825. Epub 2014 Nov 5.
- Background: PubMed 25460869Rader F, Sachdev E, Arsanjani R, Siegel RJ. Left ventricular hypertrophy in valvular aortic stenosis: mechanisms and clinical implications. Am J Med. 2015 Apr;128(4):344-52. doi: 10.1016/j.amjmed.2014.10.054. Epub 2014 Nov 25.
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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.
Ole Broch, MD principal investigator
Consultant anesthetist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing passive leg raising, premedication and intubation and mechanical ventilation in people with Hemodynamics, run by University Hospital Schleswig-Holstein at 1 site in Germany.
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 3 inclusion and 8 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 12 May 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 Germany. 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 Ole Broch, MD (+49 431-5972990, ole.broch@uksh.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Increase in stroke volume index (SVI) >15% (time frame: Patients will be obtained until the end of the operation, an expected average of 5 hours). 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 NCT02441621, which also lists 9 linked publications.
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 12 May 2015.