HypovolemiaNCT04283851
Dynamic Parameters in Evaluation of Fluid Responsiveness
An observational study of Hypovolemia and Hypotension, run by Charles University, Czech Republic at 1 site in Czechia.
Trial summary
Intravenous infusion of fluids in patients after surgery is a very important part of treatment. However, administering too much or too little fluid can lengthen the stay in the intensive care unit or even harm the patient. Therefore, fluid therapy should be tailored to the individual needs of each patient. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypovolemia, Hypotension, Surgery
- What is being tested?
- testing functional haemodynamic parameters for preload assessment
- How many people
- 50 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Feb 2020to 1 Jul 2022
- 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
- Adult, Older adult
Study population: All patients undergoing elective CABG at the Deparment of Cardiovascular Surgery of the General University Hospital in Prague, who meet all the inclusion criteria and give their informed consent.
Who may be able to join
- patients after elective coronary artery bypass grafting
- hypovolemia indicated for volumotherapy by the attending physician based on clinical and laboratory signs (ScvO2 under 65 % with serum lactate above 2 mmol/l, increase of vasopressoric support with CVP under 5 mmHg)
- intubated and ventilated patients
- sedation without spontaneous breathing activity
- no pulmonary pathology on X-ray after surgery
- normal systolic and diastolic function of both ventricles (left ventricular ejection fraction above 50 %, TAPSE of the right ventricle above 20 mm, FAC of the right ventricle above 30 %)
- informed consent signed before surgery
Who cannot join
- aggresive artificial ventilation (PEEP above 10 cmH2O, Pmax above 30 cm H2O)
- ARDS, pneumothorax, fluidothorax
- hemodynamically significant valvular disease
- atrial fibrillation or other arrhythmia with irregular heartbeat
- intraabdominal hypertension with pressures above 15 mmHg
- open thorax
- bad echogenicity
Trial locations and contacts
1 site in 1 country.
Czechia1 site
Dept of Anaesthesia and Intensive Care, General University Hospital, 1st Medical Faculty, Charles University
Prague, 120 00
About this study
Official title: Dynamic Parameters in Evaluation of Fluid Resposiveness in Cardiac Surgery Patients in the Early Postoperative Period
Intravenous infusion of fluids in patients after surgery is a very important part of treatment. However, administering too much or too little fluid can lengthen the stay in the intensive care unit or even harm the patient. Therefore, fluid therapy should be tailored to the individual needs of each patient. Several methods are available to assess which patients will likely benefit from fluid administration. However, each of these methods is useful only under certain conditions. The study aims to explore some less-known, yet promising tests which could make adequate fluid administration more precise and easier to achieve.
Read the detailed description
Adequate fluid therapy is one of the most important variables influencing patient outcome in intensive care. Fluid therapy should be tailored to the individual needs of each patient. Static parameters of preload have proved to be of little predictive value, therefore dynamic parameters are preferred for prediction of fluid responsiveness. Ideally, the cardiac output increases by 10% after a standardised fluid challenge. There are several methods already available to differentiate fluid-responsive from fluid-unresponsive patients, most notably the passive leg-raise. However, each of these methods has its own set of indications and contraindications. Also, a combination of tests could guide clinician´s decision in cases where the results of a single test are not entirely conclusive. Therefore, it would be desirable to add some less-known methods for prediction of fluid responsiveness, like the end-expiratory and end-inspiratory occlusion tests along with the assessment of diastolic properties of cardiac ventricles.
The aims of the study are:
- to determine the optimal increase in LVOT VTi to reliably predict fluid responsiveness
- to explore the accuracy of echocardiographic LVOT VTi evaluation during end-expiratory and end-inspiratory occlusion tests and their combination
- to assess the difference in echocardiographic properties of cardiac ventricles in fluid-responsive and fluid-unresponsive patients
- to compare the prediction based on echocardiography with the response to a standardised fluid challenge
- to assess the feasibility and practicality of echocardiographic monitoring in anesthetised cardiac surgery patients in intensive care
- Conditions
- Hypovolemia, Hypotension, Surgery
- Being tested
- testing functional haemodynamic parameters for preload assessment
- Keywords
- fluid responsiveness, fluid administration, volume expansion, end-expiratory occlusion test, end-inspiratory occlusion test, diastolic parameters of cardiac ventricles, echocardiography, heart-lung interactions
- Medical subject headings
- Hypovolemia, Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
testing functional haemodynamic parameters for preload assessmentDiagnostic test
dynamic testing of preload responsivity plus echocardiography
What is being measured
The primary outcome is the main question the study is designed to answer.
Prediction of fluid responsiveness
fluid responsiveness is defined as a 10 % increase in cardiac output after a standardised fluid challenge; the prediction will be made based on the diastolic properties of both cardiac ventricles and the changes in LVOT VTi during end-expiratory and end-inspiratory occlusion tests
Measured: The first hour after surgery
Secondary outcomes (6)
Echocardiographic evaluation of LVOT VTi and its changes
TTE measurement of LVOT VTi and its changes during end-expiratory, end-inspiratory occlusion tests and after a standardised fluid challenge of a colloid
Measured: The first hour after surgery
Cardiac output monitoring with Vigileo FloTrac
continous measurement of cardiac output with Vigileo FloTrac and its correlation with the changes of echocardiographic parameters
Measured: The first hour after surgery
Arterial pressure response
invasive arterial blood pressure
Measured: The first hour after surgery
Heart rate response
heart rate
Measured: The first hour after surgery
Oxygenation response
pulse oxymetry
Measured: The first hour after surgery
Central venous pressure response
central venous pressure
Measured: The first hour after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2020
- Study start1 Feb 2020
- Primary completion1 Dec 2020
- Study completion1 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for HypovolemiaStudies 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charles University, Czech Republic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martin Balik, Charles University, Czech Republic
- Investigators
- Michal Porizka, MD, PhD, Study director, Dept of Anest and Intensive Care, General University Hospital, Prague
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04283851
- Sponsor's protocol ID
- 992/19 S-IV
- Status last verified
- Mar 2023
- First submitted
- 27 Jan 2020
- Last updated
- 7 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Georges D, de Courson H, Lanchon R, Sesay M, Nouette-Gaulain K, Biais M. End-expiratory occlusion maneuver to predict fluid responsiveness in the intensive care unit: an echocardiographic study. Crit Care. 2018 Feb 8;22(1):32. doi: 10.1186/s13054-017-1938-0.
PubMed 29415773Monnet X, Marik PE, Teboul JL. Prediction of fluid responsiveness: an update. Ann Intensive Care. 2016 Dec;6(1):111. doi: 10.1186/s13613-016-0216-7. Epub 2016 Nov 17.
PubMed 27858374Monnet X, Bleibtreu A, Ferre A, Dres M, Gharbi R, Richard C, Teboul JL. Passive leg-raising and end-expiratory occlusion tests perform better than pulse pressure variation in patients with low respiratory system compliance. Crit Care Med. 2012 Jan;40(1):152-7. doi: 10.1097/CCM.0b013e31822f08d7.
PubMed 21926581Monnet X, Osman D, Ridel C, Lamia B, Richard C, Teboul JL. Predicting volume responsiveness by using the end-expiratory occlusion in mechanically ventilated intensive care unit patients. Crit Care Med. 2009 Mar;37(3):951-6. doi: 10.1097/CCM.0b013e3181968fe1.
PubMed 19237902Marques NR, De Riese J, Yelverton BC, McQuitty C, Jupiter D, Willmann K, Salter M, Kinsky M, Johnston WE. Diastolic Function and Peripheral Venous Pressure as Indices for Fluid Responsiveness in Cardiac Surgical Patients. J Cardiothorac Vasc Anesth. 2019 Aug;33(8):2208-2215. doi: 10.1053/j.jvca.2019.01.007. Epub 2019 Jan 4.
PubMed 30738752Pagourelias ED, Efthimiadis GK, Parcharidou DG, Gossios TD, Kamperidis V, Karoulas T, Karvounis H, Styliadis IH. Prognostic value of right ventricular diastolic function indices in hypertrophic cardiomyopathy. Eur J Echocardiogr. 2011 Nov;12(11):809-17. doi: 10.1093/ejechocard/jer126. Epub 2011 Aug 15.
PubMed 21846651Jozwiak M, Depret F, Teboul JL, Alphonsine JE, Lai C, Richard C, Monnet X. Predicting Fluid Responsiveness in Critically Ill Patients by Using Combined End-Expiratory and End-Inspiratory Occlusions With Echocardiography. Crit Care Med. 2017 Nov;45(11):e1131-e1138. doi: 10.1097/CCM.0000000000002704.
PubMed 28857907
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Parameters in Evaluation of Fluid Resposiveness in Cardiac Surgery Patients in the Early Postoperative Period
- ClinicalTrials.gov ID
- NCT04283851
- Acronym / sponsor ID
- 992/19 S-IV
- Conditions
- Hypovolemia, Hypotension, Surgery
- Keywords
- fluid responsiveness, fluid administration, volume expansion, end-expiratory occlusion test, end-inspiratory occlusion test, diastolic parameters of cardiac ventricles, echocardiography, heart-lung interactions
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Charles University, Czech RepublicUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 25 Feb 2020 (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.
Intravenous infusion of fluids in patients after surgery is a very important part of treatment. However, administering too much or too little fluid can lengthen the stay in the intensive care unit or even harm the patient. Therefore, fluid therapy should be tailored to the individual needs of each patient. Several methods are available to assess which patients will likely benefit from fluid administration. However, each of these methods is useful only under certain conditions. The study aims to explore some less-known, yet promising tests which could make adequate fluid administration more precise and easier to achieve.
Detailed description
Adequate fluid therapy is one of the most important variables influencing patient outcome in intensive care. Fluid therapy should be tailored to the individual needs of each patient. Static parameters of preload have proved to be of little predictive value, therefore dynamic parameters are preferred for prediction of fluid responsiveness. Ideally, the cardiac output increases by 10% after a standardised fluid challenge. There are several methods already available to differentiate fluid-responsive from fluid-unresponsive patients, most notably the passive leg-raise. However, each of these methods has its own set of indications and contraindications. Also, a combination of tests could guide clinician´s decision in cases where the results of a single test are not entirely conclusive. Therefore, it would be desirable to add some less-known methods for prediction of fluid responsiveness, like the end-expiratory and end-inspiratory occlusion tests along with the assessment of diastolic properties of cardiac ventricles.
The aims of the study are:
- to determine the optimal increase in LVOT VTi to reliably predict fluid responsiveness
- to explore the accuracy of echocardiographic LVOT VTi evaluation during end-expiratory and end-inspiratory occlusion tests and their combination
- to assess the difference in echocardiographic properties of cardiac ventricles in fluid-responsive and fluid-unresponsive patients
- to compare the prediction based on echocardiography with the response to a standardised fluid challenge
- to assess the feasibility and practicality of echocardiographic monitoring in anesthetised cardiac surgery patients in intensive care
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All patients undergoing elective CABG at the Deparment of Cardiovascular Surgery of the General University Hospital in Prague, who meet all the inclusion criteria and give their informed consent.
Key inclusion criteria (7 listed)
- patients after elective coronary artery bypass grafting
- hypovolemia indicated for volumotherapy by the attending physician based on clinical and laboratory signs (ScvO2 under 65 % with serum lactate above 2 mmol/l, increase of vasopressoric support with CVP under 5 mmHg)
- intubated and ventilated patients
- sedation without spontaneous breathing activity
- no pulmonary pathology on X-ray after surgery
Key exclusion criteria (7 listed)
- aggresive artificial ventilation (PEEP above 10 cmH2O, Pmax above 30 cm H2O)
- ARDS, pneumothorax, fluidothorax
- hemodynamically significant valvular disease
- atrial fibrillation or other arrhythmia with irregular heartbeat
- intraabdominal hypertension with pressures above 15 mmHg
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 |
|---|---|---|
| testing functional haemodynamic parameters for preload assessmentdynamic testing of preload responsivity plus echocardiography | Diagnostic test | – |
Primary outcome
Prediction of fluid responsiveness
Time frame: The first hour after surgery
fluid responsiveness is defined as a 10 % increase in cardiac output after a standardised fluid challenge; the prediction will be made based on the diastolic properties of both cardiac ventricles and the changes in LVOT VTi during end-expiratory and end-inspiratory occlusion tests
6 secondary outcomes
Echocardiographic evaluation of LVOT VTi and its changes
Time frame: The first hour after surgery
Cardiac output monitoring with Vigileo FloTrac
Time frame: The first hour after surgery
Arterial pressure response
Time frame: The first hour after surgery
Heart rate response
Time frame: The first hour after surgery
Oxygenation response
Time frame: The first hour after surgery
Central venous pressure response
Time frame: The first hour after surgery
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 7 Mar 2023.
- Background: PubMed 29415773Georges D, de Courson H, Lanchon R, Sesay M, Nouette-Gaulain K, Biais M. End-expiratory occlusion maneuver to predict fluid responsiveness in the intensive care unit: an echocardiographic study. Crit Care. 2018 Feb 8;22(1):32. doi: 10.1186/s13054-017-1938-0.
- Background: PubMed 27858374Monnet X, Marik PE, Teboul JL. Prediction of fluid responsiveness: an update. Ann Intensive Care. 2016 Dec;6(1):111. doi: 10.1186/s13613-016-0216-7. Epub 2016 Nov 17.
- Background: PubMed 21926581Monnet X, Bleibtreu A, Ferre A, Dres M, Gharbi R, Richard C, Teboul JL. Passive leg-raising and end-expiratory occlusion tests perform better than pulse pressure variation in patients with low respiratory system compliance. Crit Care Med. 2012 Jan;40(1):152-7. doi: 10.1097/CCM.0b013e31822f08d7.
- Background: PubMed 19237902Monnet X, Osman D, Ridel C, Lamia B, Richard C, Teboul JL. Predicting volume responsiveness by using the end-expiratory occlusion in mechanically ventilated intensive care unit patients. Crit Care Med. 2009 Mar;37(3):951-6. doi: 10.1097/CCM.0b013e3181968fe1.
- Background: PubMed 30738752Marques NR, De Riese J, Yelverton BC, McQuitty C, Jupiter D, Willmann K, Salter M, Kinsky M, Johnston WE. Diastolic Function and Peripheral Venous Pressure as Indices for Fluid Responsiveness in Cardiac Surgical Patients. J Cardiothorac Vasc Anesth. 2019 Aug;33(8):2208-2215. doi: 10.1053/j.jvca.2019.01.007. Epub 2019 Jan 4.
- Background: PubMed 21846651Pagourelias ED, Efthimiadis GK, Parcharidou DG, Gossios TD, Kamperidis V, Karoulas T, Karvounis H, Styliadis IH. Prognostic value of right ventricular diastolic function indices in hypertrophic cardiomyopathy. Eur J Echocardiogr. 2011 Nov;12(11):809-17. doi: 10.1093/ejechocard/jer126. Epub 2011 Aug 15.
- Results publication: PubMed 28857907Jozwiak M, Depret F, Teboul JL, Alphonsine JE, Lai C, Richard C, Monnet X. Predicting Fluid Responsiveness in Critically Ill Patients by Using Combined End-Expiratory and End-Inspiratory Occlusions With Echocardiography. Crit Care Med. 2017 Nov;45(11):e1131-e1138. doi: 10.1097/CCM.0000000000002704.
- Individual participant dataSharing planned: Undecided
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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.
Michal Porizka, MD, PhD study director
Dept of Anest and Intensive Care, General University Hospital, Prague
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 Hypovolemia and Hypotension, run by Charles University, Czech Republic at 1 site in Czechia.
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 7 inclusion and 7 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 7 Mar 2023. 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 Czechia. 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?
Prediction of fluid responsiveness (time frame: The first hour after surgery). 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 NCT04283851, which also lists 7 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 7 Mar 2023.