Dynamic Parameters in Evaluation of Fluid Responsiveness

NCT04283851 | Completed

• 1 other identifier: 992/19 S-IV
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Echocardiographic evaluation of LVOT VTi and its changes

  The first hour after surgery

• Cardiac output monitoring with Vigileo FloTrac

  The first hour after surgery

• Arterial pressure response

  The first hour after surgery

• Heart rate response

  The first hour after surgery

• Oxygenation response

  The first hour after surgery

Interventions

testing functional haemodynamic parameters for preload assessment DIAGNOSTIC_TEST

dynamic testing of preload responsivity plus echocardiography

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Charles University, Czech Republic: lead

Study Sites (1)

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

Prague, 120 00, Czechia

Location

Related Publications (7)

• 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.

  PMID: 29415773 BACKGROUND

• 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.

  PMID: 27858374 BACKGROUND

• 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.

  PMID: 21926581 BACKGROUND

• 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.

  PMID: 19237902 BACKGROUND

• 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.

  PMID: 30738752 BACKGROUND

• 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.

  PMID: 21846651 BACKGROUND

• 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.

  PMID: 28857907 RESULT

MeSH Terms

Conditions

Hypovolemia; Hypotension

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Michal Porizka, MD, PhD

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

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator: Jan Horejsek, General University Hospital in Prague

Study Record Dates

• First Submitted: January 27, 2020
• First Posted: February 25, 2020
• Study Start: February 1, 2020
• Primary Completion: December 1, 2020
• Study Completion: July 1, 2022
• Last Updated: March 7, 2023

Record last verified: 2023-03

Locations

CZ (1)