Surgery Clinical Trial
Official title:
Dynamic Parameters in Evaluation of Fluid Resposiveness in Cardiac Surgery Patients in the Early Postoperative Period
NCT number | NCT04283851 |
Other study ID # | 992/19 S-IV |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | February 1, 2020 |
Est. completion date | July 1, 2022 |
Verified date | March 2023 |
Source | Charles University, Czech Republic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 50 |
Est. completion date | July 1, 2022 |
Est. primary completion date | December 1, 2020 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Czechia | Dept of Anaesthesia and Intensive Care, General University Hospital, 1st Medical Faculty, Charles University | Prague 2 |
Lead Sponsor | Collaborator |
---|---|
Charles University, Czech Republic |
Czechia,
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. — View 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):e11 — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | The first hour after surgery | |
Secondary | 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 | The first hour after surgery | |
Secondary | Cardiac output monitoring with Vigileo FloTrac | continous measurement of cardiac output with Vigileo FloTrac and its correlation with the changes of echocardiographic parameters | The first hour after surgery | |
Secondary | Arterial pressure response | invasive arterial blood pressure | The first hour after surgery | |
Secondary | Heart rate response | heart rate | The first hour after surgery | |
Secondary | Oxygenation response | pulse oxymetry | The first hour after surgery | |
Secondary | Central venous pressure response | central venous pressure | The first hour after surgery |
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