NCT05211765

Brief Summary

Fluid evaluation is relevant in critical care. Cardiac ultrasound is the first line of evaluation in hemodynamic characterization of patients in shock, to tailor therapy. Fluid responsiveness predictors allow to better decide when to administer fluids, and transesophagic view of superior vena cava is an effective one. Recently a transthoracic view of the superior vena cava has been described. The investigators aim to evaluate if the variations of superior vena cava can predict fluid responsiveness in critically il, ventilated patients. Hypothesis: Respiratory variations of superior vena cava diameter, evaluated with transthoracic ultrasound, can predict fluid responsiveness

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 7, 2021

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

December 28, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 27, 2022

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
Last Updated

November 29, 2023

Status Verified

November 1, 2023

Enrollment Period

2.7 years

First QC Date

December 28, 2021

Last Update Submit

November 27, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Fluid responsiveness

    An increase of 10% or more in the left ventricle velocity time integral value (average of 3 in regular rhythms or 5 in irregular rhythms) measured with cardiac ultrasound in 5 chambers apical view after the infusion of 100ml bolus of intravenous crystalloid solution.

    1 minute

Interventions

The superior vena cava will be observed with a cardiac ultrasound machine, its diameter in different respiratory phases evaluated and compared with fluid response.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Ventilated critically ill patients with hemodynamic instability hospitalized in the intensive care unit.

You may qualify if:

  • Patients \>18 years,
  • Hospitalized in the Intensive Care Unit (ICU) with length of stay under 7 days
  • Under positive pressure ventilation with no inspiratory effort,
  • With hemodynamic instability (defined as abnormal peripheral perfusion or increased blood lactic or vasopressor infusion of norepinephrine \>0.1 ug/kg/min to achieve adequate mean arterial pressure)

You may not qualify if:

  • Spontaneous ventilatory effort
  • Lack of venous access
  • Carrier of carbapenemase or clostridium difficile
  • Lack of adequate superior vena cava (SVC) window (not allowing M-mode during both respiratory phases)
  • Severe aortic regurgitation
  • Impossibility to measure LVOT-VTI
  • Extracorporeal membrane oxygenation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital ClĂ­nico Universidad de Chile

Santiago, Santiago Metropolitan, 8380420, Chile

RECRUITING

Related Publications (22)

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    PMID: 28101605BACKGROUND
  • Reuter DA, Chappell D, Perel A. The dark sides of fluid administration in the critically ill patient. Intensive Care Med. 2018 Jul;44(7):1138-1140. doi: 10.1007/s00134-017-4989-4. Epub 2017 Nov 11. No abstract available.

    PMID: 29128963BACKGROUND
  • Malbrain MLNG, Van Regenmortel N, Saugel B, De Tavernier B, Van Gaal PJ, Joannes-Boyau O, Teboul JL, Rice TW, Mythen M, Monnet X. Principles of fluid management and stewardship in septic shock: it is time to consider the four D's and the four phases of fluid therapy. Ann Intensive Care. 2018 May 22;8(1):66. doi: 10.1186/s13613-018-0402-x.

    PMID: 29789983BACKGROUND
  • Acheampong A, Vincent JL. A positive fluid balance is an independent prognostic factor in patients with sepsis. Crit Care. 2015 Jun 15;19(1):251. doi: 10.1186/s13054-015-0970-1.

    PMID: 26073560BACKGROUND
  • Cecconi M, Hofer C, Teboul JL, Pettila V, Wilkman E, Molnar Z, Della Rocca G, Aldecoa C, Artigas A, Jog S, Sander M, Spies C, Lefrant JY, De Backer D; FENICE Investigators; ESICM Trial Group. Fluid challenges in intensive care: the FENICE study: A global inception cohort study. Intensive Care Med. 2015 Sep;41(9):1529-37. doi: 10.1007/s00134-015-3850-x. Epub 2015 Jul 11.

    PMID: 26162676BACKGROUND
  • Bednarczyk JM, Fridfinnson JA, Kumar A, Blanchard L, Rabbani R, Bell D, Funk D, Turgeon AF, Abou-Setta AM, Zarychanski R. Incorporating Dynamic Assessment of Fluid Responsiveness Into Goal-Directed Therapy: A Systematic Review and Meta-Analysis. Crit Care Med. 2017 Sep;45(9):1538-1545. doi: 10.1097/CCM.0000000000002554.

    PMID: 28817481BACKGROUND
  • 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: 27858374BACKGROUND
  • Vistisen ST, Juhl-Olsen P. Where are we heading with fluid responsiveness research? Curr Opin Crit Care. 2017 Aug;23(4):318-325. doi: 10.1097/MCC.0000000000000421.

    PMID: 28537997BACKGROUND
  • Michard F. Toward Precision Hemodynamic Management. Crit Care Med. 2017 Aug;45(8):1421-1423. doi: 10.1097/CCM.0000000000002458. No abstract available.

    PMID: 28708687BACKGROUND
  • Vignon P, Repesse X, Begot E, Leger J, Jacob C, Bouferrache K, Slama M, Prat G, Vieillard-Baron A. Comparison of Echocardiographic Indices Used to Predict Fluid Responsiveness in Ventilated Patients. Am J Respir Crit Care Med. 2017 Apr 15;195(8):1022-1032. doi: 10.1164/rccm.201604-0844OC.

    PMID: 27653798BACKGROUND
  • 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: 19237902BACKGROUND
  • Monnet X, Marik P, Teboul JL. Passive leg raising for predicting fluid responsiveness: a systematic review and meta-analysis. Intensive Care Med. 2016 Dec;42(12):1935-1947. doi: 10.1007/s00134-015-4134-1. Epub 2016 Jan 29.

    PMID: 26825952BACKGROUND
  • Biais M, Ehrmann S, Mari A, Conte B, Mahjoub Y, Desebbe O, Pottecher J, Lakhal K, Benzekri-Lefevre D, Molinari N, Boulain T, Lefrant JY, Muller L; AzuRea Group. Clinical relevance of pulse pressure variations for predicting fluid responsiveness in mechanically ventilated intensive care unit patients: the grey zone approach. Crit Care. 2014 Nov 4;18(6):587. doi: 10.1186/s13054-014-0587-9.

    PMID: 25658489BACKGROUND
  • Muller L, Toumi M, Bousquet PJ, Riu-Poulenc B, Louart G, Candela D, Zoric L, Suehs C, de La Coussaye JE, Molinari N, Lefrant JY; AzuRea Group. An increase in aortic blood flow after an infusion of 100 ml colloid over 1 minute can predict fluid responsiveness: the mini-fluid challenge study. Anesthesiology. 2011 Sep;115(3):541-7. doi: 10.1097/ALN.0b013e318229a500.

    PMID: 21792056BACKGROUND
  • Wu Y, Zhou S, Zhou Z, Liu B. A 10-second fluid challenge guided by transthoracic echocardiography can predict fluid responsiveness. Crit Care. 2014 May 27;18(3):R108. doi: 10.1186/cc13891.

    PMID: 24886990BACKGROUND
  • Vieillard-Baron A, Naeije R, Haddad F, Bogaard HJ, Bull TM, Fletcher N, Lahm T, Magder S, Orde S, Schmidt G, Pinsky MR. Diagnostic workup, etiologies and management of acute right ventricle failure : A state-of-the-art paper. Intensive Care Med. 2018 Jun;44(6):774-790. doi: 10.1007/s00134-018-5172-2. Epub 2018 May 9.

    PMID: 29744563BACKGROUND
  • Jardin F, Dubourg O, Margairaz A, Bourdarias JP. Inspiratory impairment in right ventricular performance during acute asthma. Chest. 1987 Nov;92(5):789-95. doi: 10.1378/chest.92.5.789.

    PMID: 3665592BACKGROUND
  • Jardin F, Dubourg O, Bourdarias JP. Echocardiographic pattern of acute cor pulmonale. Chest. 1997 Jan;111(1):209-17. doi: 10.1378/chest.111.1.209. No abstract available.

    PMID: 8996019BACKGROUND
  • Ugalde D, Haruel PA, Godement M, Prigent A, Vieillard-Baron A. Transthoracic echocardiography to evaluate the superior vena cava in critically ill patients: window description and pilot study. Intensive Care Med. 2019 Jul;45(7):1052-1054. doi: 10.1007/s00134-019-05621-1. Epub 2019 Apr 25. No abstract available.

    PMID: 31041478BACKGROUND
  • Messina A, Dell'Anna A, Baggiani M, Torrini F, Maresca GM, Bennett V, Saderi L, Sotgiu G, Antonelli M, Cecconi M. Functional hemodynamic tests: a systematic review and a metanalysis on the reliability of the end-expiratory occlusion test and of the mini-fluid challenge in predicting fluid responsiveness. Crit Care. 2019 Jul 29;23(1):264. doi: 10.1186/s13054-019-2545-z.

    PMID: 31358025BACKGROUND
  • Jozwiak M, Mercado P, Teboul JL, Benmalek A, Gimenez J, Depret F, Richard C, Monnet X. What is the lowest change in cardiac output that transthoracic echocardiography can detect? Crit Care. 2019 Apr 11;23(1):116. doi: 10.1186/s13054-019-2413-x.

    PMID: 30971307BACKGROUND
  • Ugalde D, Montoya J, Medel JN, Eisen D, Vieillard-Baron A. Diagnostic accuracy of superior vena cava variability by transthoracic echocardiography as a fluid responsiveness predictor in critically ill patients. J Crit Care. 2026 Apr;92:155420. doi: 10.1016/j.jcrc.2025.155420. Epub 2025 Dec 23.

MeSH Terms

Conditions

Shock

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

December 28, 2021

First Posted

January 27, 2022

Study Start

March 7, 2021

Primary Completion

November 1, 2023

Study Completion

March 1, 2024

Last Updated

November 29, 2023

Record last verified: 2023-11

Locations