Dynamic Parameters in Evaluation of Fluid Responsiveness

NCT ID: NCT04283851

Last Updated: 2023-03-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-02-01

Study Completion Date

2022-07-01

Brief Summary

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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

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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

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Hypovolemia Hypotension Surgery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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testing functional haemodynamic parameters for preload assessment

dynamic testing of preload responsivity plus echocardiography

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Charles University, Czech Republic

OTHER

Sponsor Role lead

Responsible Party

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Martin Balik

Principal Investigator: Jan Horejsek, General University Hospital in Prague

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michal Porizka, MD, PhD

Role: STUDY_DIRECTOR

Dept of Anest and Intensive Care, General University Hospital, Prague

Locations

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Dept of Anaesthesia and Intensive Care, General University Hospital, 1st Medical Faculty, Charles University

Prague, , Czechia

Site Status

Countries

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Czechia

References

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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.

Reference Type BACKGROUND
PMID: 29415773 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27858374 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21926581 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19237902 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30738752 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21846651 (View on PubMed)

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.

Reference Type RESULT
PMID: 28857907 (View on PubMed)

Other Identifiers

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992/19 S-IV

Identifier Type: -

Identifier Source: org_study_id

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