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Carotid Doppler and EEOT for Fluid Responsiveness Prediction

Primary Purpose

Septic Shock

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
End-expiratory occlusion test (EEOT)
Sponsored by
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Septic Shock focused on measuring end-expiratory occlusion test, septic shock, carotid doppler

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion criteria:

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

Sites / Locations

  • Fondazione Policlinico Universitario A. Gemelli IRCCS

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

septic shock patients

Arm Description

Intubated 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.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Full Information

First Posted
July 6, 2020
Last Updated
June 28, 2021
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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1. Study Identification

Unique Protocol Identification Number
NCT04470856
Brief Title
Carotid Doppler and EEOT for Fluid Responsiveness Prediction
Official Title
Can Carotid Artery Doppler Variations Induced by End-expiratory Occlusion Manoeuvre Predict Fluid Responsiveness in Septic Shock Patients?
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
July 30, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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 introduced in order to identify fluid responders and non-responders without fluid challenge administration. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Septic Shock
Keywords
end-expiratory occlusion test, septic shock, carotid doppler

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
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)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
septic shock patients
Arm Type
Experimental
Arm Description
Intubated 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.
Intervention Type
Diagnostic Test
Intervention Name(s)
End-expiratory occlusion test (EEOT)
Intervention Description
An occlusion manoeuvre during the end of expiration for 20 seconds
Primary Outcome Measure Information:
Title
Fluid responsiveness
Description
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)
Time Frame
during EEOT

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion criteria: age< 18 y old significant valvular heart diseases cardiac arrhythmia peripheral arterial disease common carotid artery stenosis greater than 50% spontaneous breathing.
Facility Information:
Facility Name
Fondazione Policlinico Universitario A. Gemelli IRCCS
City
Roma
State/Province
RM
ZIP/Postal Code
00168
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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25435480
Citation
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Results Reference
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Citation
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Results Reference
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PubMed Identifier
27922879
Citation
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.
Results Reference
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PubMed Identifier
24930363
Citation
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Citation
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Results Reference
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Citation
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Results Reference
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Carotid Doppler and EEOT for Fluid Responsiveness Prediction

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