Evaluation of New Hemodynamic Indices

Septic Shock Clinical Trial

— EVOLVE  

Official title:

Evaluation of New Hemodynamic Indices to Predict Response to Volemic Expansion in Septic Shock

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03961594
• Other study ID #: '2018-38'
• Secondary ID: 2018-A01078-47
• Status: Recruiting
• Phase: N/A
• Start date: July 19, 2018
• Est. completion date: January 1, 2020

Study information

• Verified date: May 2019
• Source: Assistance Publique Hopitaux De Marseille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 51
• Est. completion date: January 1, 2020
• Est. primary completion date: September 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Septic Shock
• Shock, Septic

Intervention

Other:
• expansion volémique
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.

Locations

Country	Name	City	State
France	Assistance Publique Hopitaux de Marseille	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	20 minutes