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Septic ShockNCT04470856

Carotid Doppler and EEOT for Fluid Responsiveness Prediction

A study testing End-expiratory occlusion test (EEOT) in people with Septic Shock, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Fluid responsiveness prediction prior to fluid challenge administration is a topic of interest, which has been extensively investigated, but remains challenging. In clinical practice, functional hemodynamic tests (FHT) consisting of maneuvers that affect cardiac function and/or heart-lung interaction, have been… Read more about this study

Who is it for?
Any age
Conditions the study is for
Septic Shock
What is being tested?
End-expiratory occlusion test (EEOT)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteItaly
Study dates
1 Jan 2019to 31 Dec 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • sedated and mechanically ventilated patients
  • need a fluid challenge
  • hypotension defined as a systolic arterial pressure ≤90 mmHg
  • tachycardia ≥100 beats/min
  • urinary flow ≤0.5 mL/kg/min for 2 hrs

Who cannot join

  • age< 18 y old
  • significant valvular heart diseases
  • cardiac arrhythmia
  • peripheral arterial disease
  • common carotid artery stenosis greater than 50%
  • spontaneous breathing.

Trial locations and contacts

1 site in 1 country.

Italy1 site
  • Fondazione Policlinico Universitario A. Gemelli IRCCS

    Roma, RM, 00168

Other trials in Italy

About this study

Official title: Can Carotid Artery Doppler Variations Induced by End-expiratory Occlusion Manoeuvre Predict Fluid Responsiveness in Septic Shock Patients?

Fluid responsiveness prediction prior to fluid challenge administration is a topic of interest, which has been extensively investigated, but remains challenging.

In clinical practice, functional hemodynamic tests (FHT) consisting of maneuvers that affect cardiac function and/or heart-lung interaction, have been introduced in order to identify fluid responders and non-responders without fluid challenge administration.

Read more

Changes in cardiac output induced by the Passive Leg Raising (PLR) test reliably predicted the increase in cardiac output to volume expansion. New approaches have been recently developed based on changes in respiratory dynamics, such as a transient increase in tidal volume, or a lung recruitment maneuver or an end-expiratory occlusion (EEO) test. The EEO leaded to an increase in venous return, cardiac preload and stroke volume in preload-responsive patients. The authors found that an increase in cardiac output ≥ 5% during a 15-s EEO reliably predicted its response to a 500-ml saline infusion.

However, in order to identify the rapid and transient increase in cardiac index during the EEO, continuous and instantaneous cardiac output monitoring is necessary. Pulse contour analysis methods provide a beat-to-beat estimation of cardiac output and had been used in most of studies validating the EEO test.

Carotid doppler is a non-invasive, bedside, easy to use ultrasound technique that measuring blood flow peak velocity (CDPV) and duration of systolic component of each cardiac cycle (from the onset to dicrotic notch- Flow time - FT) allows a reliable estimation of fluid status and could be an interesting alternative to track changes in SV and cardiac output.

Read the detailed description

The aim of the present study is to investigate whether changes in systolic peak velocity (ΔV peak-CA) and in flow time (ΔFT) using carotid artery Doppler during an End-Expiratory Occlusion Test (EEOT) predict fluid responsiveness in patients with septic shock and lung protective mechanical ventilation in ICU.

All patients will be in supine position (trunk elevated 30°), sedated, paralyzed and mechanically ventilated in the volume control mode. Tidal volume will be set at 6-8 ml/kg of predicted body weight.

They will be all monitored by an EV1000TM/Volume View (Edwards Lifesciences Corporation, Irvine, CA 92614) for measurement of cardiac index through transpulmonary thermodilution (TPTD) and pulse contour analysis. Cardiac index and the other hemodynamic parameters derived from pulse contour analysis will be continuously recorded over a 20-sec period.

Phase 1 (baseline): a first set of TPTD will be performed to assess the cardiac index (CI), the stroke volume index (SVI), the stroke volume variation (SVV), the systemic vascular resistance index (SVRI). The mean arterial pressure (MAP), heart rate (HR), central venous pressure (CVP) were also recorded. A carotid doppler was performed to measure the systolic peak velocity (CDPV) and the flow time (FT) (see below).

Phase 2 (EEOT): A 20-second EEO will be than applied through a touch of ventilator for measuring the total end-expiratory pressure. MAP, HR, SVI, CVP, SVRI, pulse contour-derived CI were averaged during the 5 last seconds of the EEO because the maximal hemodynamic effects of the occlusion were observed at this time and because the EV1000TM monitor updates the data every 20 seconds. During this pause a carotid Doppler will be performed and the last 5 seconds will be recorded.

The effects of EEOT on cardiac index will be measured by pulse contour analysis and not by TPTD because these effects must be assessed by a real-time monitoring technique. In practice, the investigators will observe the continuously changing values of pulse contour analysis-derived cardiac index while performing the Doppler measurements.

Phase 3 (fluid challenge): The patients then will receive a 10-minute infusion of 500 mL saline or lactate ringer (7 ml/kg). A last set of hemodynamic measurements, including CI, MAP, HR, SVI, CVP, SVRI, and carotid Doppler, will be recorded after fluid infusion.

As soon as the cardiac index value started to increase, the investigators will consider that it had reached its maximum. At this precise time, they will freeze the image of the echograph and performed the Doppler measurements on the values displayed during the previous seconds. If pulse contour analysis-derived cardiac index will increase ≥ 5% during the EEOT, compared to the baseline value, the patient will be consider as responder to the test.

Catecholamine's infusion, mechanical ventilation settings and bed position will be kept constant during the study period.

Conditions
Septic Shock
Being tested
End-expiratory occlusion test (EEOT)
Keywords
end-expiratory occlusion test, septic shock, carotid doppler
Medical subject headings
Shock, Septic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • End-expiratory occlusion test (EEOT)Diagnostic test

    An occlusion manoeuvre during the end of expiration for 20 seconds

Study groups in NCT04470856
Study groupRoleWhat they receive
septic shock patientsExperimentalIntubated patients with septic shock receive an end-expiratory occlusion test (EEOT) and, after the test, they receive a 500 ml-fluid challenge. During these phases the carotid doppler changes will be recorded.
Receives: Diagnostic Test: End-expiratory occlusion test (EEOT)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Fluid responsiveness

    Evaluation of changes in systolic peak velocity (ΔV peak-CA) and in flow time (ΔFT) using carotid artery Doppler during an end-expiratory occlusion test and after fluid-challenge (500 ml)

    Measured: during EEOT

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jul 2020
  2. Study start1 Jan 2019
  3. Primary completion30 Jul 2020
  4. Study completion31 Dec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Sequential
Model description
Participants receive an 20sec-EEOT at the initial phase of the study, then they receive a fluid challenge during the second phase of the study
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04470856
Sponsor's protocol ID
1677
Status last verified
Jun 2021
First submitted
6 Jul 2020
Last updated
1 Jul 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Pinsky MR. Functional hemodynamic monitoring. Crit Care Clin. 2015 Jan;31(1):89-111. doi: 10.1016/j.ccc.2014.08.005.

    PubMed 25435480
  • 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.

    PubMed 19237902
  • Myatra SN, Prabu NR, Divatia JV, Monnet X, Kulkarni AP, Teboul JL. The Changes in Pulse Pressure Variation or Stroke Volume Variation After a "Tidal Volume Challenge" Reliably Predict Fluid Responsiveness During Low Tidal Volume Ventilation. Crit Care Med. 2017 Mar;45(3):415-421. doi: 10.1097/CCM.0000000000002183.

    PubMed 27922879
  • Blehar DJ, Glazier S, Gaspari RJ. Correlation of corrected flow time in the carotid artery with changes in intravascular volume status. J Crit Care. 2014 Aug;29(4):486-8. doi: 10.1016/j.jcrc.2014.03.025. Epub 2014 Apr 2.

    PubMed 24930363
  • Mackenzie DC, Khan NA, Blehar D, Glazier S, Chang Y, Stowell CP, Noble VE, Liteplo AS. Carotid Flow Time Changes With Volume Status in Acute Blood Loss. Ann Emerg Med. 2015 Sep;66(3):277-282.e1. doi: 10.1016/j.annemergmed.2015.04.014. Epub 2015 May 21.

    PubMed 26003002
  • Hossein-Nejad H, Mohammadinejad P, Lessan-Pezeshki M, Davarani SS, Banaie M. Carotid artery corrected flow time measurement via bedside ultrasonography in monitoring volume status. J Crit Care. 2015 Dec;30(6):1199-203. doi: 10.1016/j.jcrc.2015.08.014. Epub 2015 Aug 22.

    PubMed 26410681
  • Shokoohi H, Berry GW, Shahkolahi M, King J, King J, Salimian M, Poshtmashad A, Pourmand A. The diagnostic utility of sonographic carotid flow time in determining volume responsiveness. J Crit Care. 2017 Apr;38:231-235. doi: 10.1016/j.jcrc.2016.10.025. Epub 2016 Nov 9.

    PubMed 27987483
  • Ibarra-Estrada MA, Lopez-Pulgarin JA, Mijangos-Mendez JC, Diaz-Gomez JL, Aguirre-Avalos G. Respiratory variation in carotid peak systolic velocity predicts volume responsiveness in mechanically ventilated patients with septic shock: a prospective cohort study. Crit Ultrasound J. 2015 Dec;7(1):29. doi: 10.1186/s13089-015-0029-1. Epub 2015 Jun 26.

    PubMed 26123610
  • Cecconi M, De Backer D, Antonelli M, Beale R, Bakker J, Hofer C, Jaeschke R, Mebazaa A, Pinsky MR, Teboul JL, Vincent JL, Rhodes A. Consensus on circulatory shock and hemodynamic monitoring. Task force of the European Society of Intensive Care Medicine. Intensive Care Med. 2014 Dec;40(12):1795-815. doi: 10.1007/s00134-014-3525-z. Epub 2014 Nov 13.

    PubMed 25392034
  • D'Arrigo S, Dell'Anna AM, Sandroni C, Messina A, Cacciola S, Pacini C, Antonelli M. Can carotid artery Doppler variations induced by the end-expiratory occlusion maneuver predict fluid responsiveness in septic shock patients? Crit Care. 2023 Apr 19;27(1):153. doi: 10.1186/s13054-023-04422-9.

    PubMed 37076861

Questions about this trial

What is this clinical trial studying?

A study testing End-expiratory occlusion test (EEOT) in people with Septic Shock, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fluid responsiveness (time frame: during EEOT). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04470856, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2021.

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