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Evaluation of New Hemodynamic Indices (EVOLVE)

Primary Purpose

Septic Shock

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
expansion volémique
Sponsored by
Assistance Publique Hopitaux De Marseille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Septic Shock

Eligibility Criteria

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

Inclusion Criteria:

  • Patient presenting a shock whose etiology is considered as septic.
  • Patient whose hemodynamic state justifies the infusion of vasopressor.
  • Patient monitored by a cardiac output measurement system calibrated by transpulmonary thermodilution.
  • Intubated patient with expired capnia monitoring
  • Patient with signs of low cardiac output

Exclusion Criteria:

  • Patient with a contraindication in the leg lift test.
  • Patient with abdominal compartment syndrome.
  • Patient with amputation of one or both lower limbs.
  • Pregnant woman eliminated by a systematic pregnancy test at the entrance to the intensive care unit.
  • Minor patient.
  • Refusal to participate in the study.

Sites / Locations

  • Assistance Publique Hopitaux de MarseilleRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

volume expansion in the ventilated patient

Arm Description

Including 51 patients, ventilated, under vasopressors suffering from septic shock. GLS, cardiac output, VVP, VVE, blood pressure, Eadyn, EtCO2 will be measured before and after ELJP. In the event of an increase of more than 10% in cardiac output during the ELJP, patients will receive a volume expansion of 500ml of balanced crystalloids. The same measurements will be repeated immediately at the end of the volume expansion and 20 minutes after the end of the infusion. Patients with a 15% increase in cardiac output at the end of volume expansion will be classified as responders. Patients with a 15% increase in cardiac output 20minutes after the end of volume expansion will be classified as persistent responders.

Outcomes

Primary Outcome Measures

Passive leg lift test (ELJP)
The ELJP consists of a tilting maneuver of the patient's bed from a proclive position at 30 ° to a 0 ° chest position and limbs less than 30 °. This maneuver allows the recruitment of venous blood contained in the lower limbs to the heart and to "mimic" a test of volemic expansion and its hemodynamic repercussions. This maneuver is widely described in the literature for this indication and does not involve any particular risk for the patient. The measurements are made at 1 minute of the end of the tilting (chest at 0 °). The maneuver lasts 1min30 before returning the patient to his initial position

Secondary Outcome Measures

Full Information

First Posted
May 21, 2019
Last Updated
May 22, 2019
Sponsor
Assistance Publique Hopitaux De Marseille
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1. Study Identification

Unique Protocol Identification Number
NCT03961594
Brief Title
Evaluation of New Hemodynamic Indices
Acronym
EVOLVE
Official Title
Evaluation of New Hemodynamic Indices to Predict Response to Volemic Expansion in Septic Shock
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 19, 2018 (Actual)
Primary Completion Date
September 1, 2018 (Actual)
Study Completion Date
January 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille

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
The objective is to determine the sensitivity and specificity via Receiver Operating Characteristic (ROC) curve of Global Longitudinal Strain (GLS) The secondary objectives are the same for the change in the amount of carbon dioxide exhaled (ΔEtCO2) and dynamic arterial elastance (Eadyn). it will also determine the sensitivity and specificity of these indices, either individually or combined to determine persistent responders to volemic expansion.
Detailed Description
The best practice recommendations are to evaluate the preload dependence before performing a vascular filling test. This evaluation is based on the analysis of dynamic hemodynamic indices such as the variation of pulsed pressure (VPP), the variation of the volume of ejection (VVE) or the variation of the cardiac output during the realization of a test of rising of passive leg (ELJP). However, these indices require strict validation conditions. New hemodynamic indices have appeared recently and appear promising in the evaluation of preload dependence. Among them, the analysis of longitudinal myocardial deformity by speckle tracking (GLS) and its variation during an ELJP (ΔGLS). The analysis of changes in the amount of CO2 exhaled (ΔEtCO2) reflects cardiac output in ventilated patients or the analysis of dynamic arterial elastance (Eadyn) calculated by comparing the VPP and the EVV which is a reflection of the coupling between the left ventricle and the arterial network. In this work the assumption that the analysis of Δ GLS, ΔEtCO2 and Eadyn can predict the response to volume expansion in the ventilated patient, in septic shock under vasopressor. The investigators include at least 51 patients, ventilated, under vasopressors with septic shock. GLS, cardiac output, VVP, VVE, blood pressure, Eadyn, EtCO2 will be measured before and after ELJP. In the event of an increase of more than 10% in cardiac output during the ELJP, patients will receive a volume expansion of 500ml of balanced crystalloids. The same measurements will be repeated immediately at the end of the volume expansion and 20 minutes after the end of the infusion. Patients with a 15% increase in cardiac output at the end of volume expansion will be classified as responders. Patients with a 15% increase in cardiac output 20minutes after the end of volume expansion will be classified as persistent responders.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Septic Shock

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Inclusions will be based on the formal preliminary indication of a volume expansion test to avoid over inclusions and side effects of an undesired volume expansion. The collection of data is done in daily practice, relies on routine care and does not require additional devices
Masking
None (Open Label)
Allocation
N/A
Enrollment
51 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
volume expansion in the ventilated patient
Arm Type
Other
Arm Description
Including 51 patients, ventilated, under vasopressors suffering from septic shock. GLS, cardiac output, VVP, VVE, blood pressure, Eadyn, EtCO2 will be measured before and after ELJP. In the event of an increase of more than 10% in cardiac output during the ELJP, patients will receive a volume expansion of 500ml of balanced crystalloids. The same measurements will be repeated immediately at the end of the volume expansion and 20 minutes after the end of the infusion. Patients with a 15% increase in cardiac output at the end of volume expansion will be classified as responders. Patients with a 15% increase in cardiac output 20minutes after the end of volume expansion will be classified as persistent responders.
Intervention Type
Other
Intervention Name(s)
expansion volémique
Intervention Description
cardiac output, VVP, VVE, blood pressure, Eadyn, EtCO2 will be measured before and after ELJP. In the event of an increase of more than 10% in cardiac output during the ELJP, patients will receive a volume expansion of 500ml of balanced crystalloids. The same measurements will be repeated immediately at the end of the volume expansion and 20 minutes after the end of the infusion. Patients with a 15% increase in cardiac output at the end of volume expansion will be classified as responders.
Primary Outcome Measure Information:
Title
Passive leg lift test (ELJP)
Description
The ELJP consists of a tilting maneuver of the patient's bed from a proclive position at 30 ° to a 0 ° chest position and limbs less than 30 °. This maneuver allows the recruitment of venous blood contained in the lower limbs to the heart and to "mimic" a test of volemic expansion and its hemodynamic repercussions. This maneuver is widely described in the literature for this indication and does not involve any particular risk for the patient. The measurements are made at 1 minute of the end of the tilting (chest at 0 °). The maneuver lasts 1min30 before returning the patient to his initial position
Time Frame
20 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient presenting a shock whose etiology is considered as septic. Patient whose hemodynamic state justifies the infusion of vasopressor. Patient monitored by a cardiac output measurement system calibrated by transpulmonary thermodilution. Intubated patient with expired capnia monitoring Patient with signs of low cardiac output Exclusion Criteria: Patient with a contraindication in the leg lift test. Patient with abdominal compartment syndrome. Patient with amputation of one or both lower limbs. Pregnant woman eliminated by a systematic pregnancy test at the entrance to the intensive care unit. Minor patient. Refusal to participate in the study.
Facility Information:
Facility Name
Assistance Publique Hopitaux de Marseille
City
Marseille
ZIP/Postal Code
13354
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gary DUCLOS
Phone
0637365425
Email
gary.duclos@ap-hm.fr
First Name & Middle Initial & Last Name & Degree
Kahena AMICHI
Email
promotion.interne@ap-hm.fr

12. IPD Sharing Statement

Learn more about this trial

Evaluation of New Hemodynamic Indices

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