Clinical trial NCT04283851: Dynamic Parameters in Evaluation of Fluid Responsiveness
Official title: Dynamic Parameters in Evaluation of Fluid Resposiveness in Cardiac Surgery Patients in the Early Postoperative Period
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: Charles University, Czech Republic
Sponsor class: OTHER
First posted: 2020-02-25
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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. 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

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Prediction of fluid responsiveness
timeFrame: The first hour after surgery
Secondary outcomes:
measure: Echocardiographic evaluation of LVOT VTi and its changes
timeFrame: The first hour after surgery
measure: Cardiac output monitoring with Vigileo FloTrac
timeFrame: The first hour after surgery
measure: Arterial pressure response
timeFrame: The first hour after surgery
measure: Heart rate response
timeFrame: The first hour after surgery
measure: Oxygenation response
timeFrame: The first hour after surgery
measure: Central venous pressure response
timeFrame: The first hour after surgery
Other outcomes:
Locations:
city: Prague 2
country: Czechia
facility: Dept of Anaesthesia and Intensive Care, General University Hospital, 1st Medical Faculty, Charles University
Study officials:
affiliation: Dept of Anest and Intensive Care, General University Hospital, Prague
name: Michal Porizka, MD, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Monnet 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.
citation: Monnet 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.
citation: Monnet 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.
citation: Marques 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.
citation: Pagourelias 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.
citation: Jozwiak 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.