Evaluation of New Hemodynamic Indices

NCT03961594 | Unknown DMC

• 2 other identifiers: '2018-38'2018-A01078-47
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Septic Shock

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

volume expansion in the ventilated patient

OTHER

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.

Other: expansion volémique

Interventions

expansion volémique OTHER

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.

volume expansion in the ventilated patient

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Assistance Publique Hopitaux de Marseille

Marseille, 13354, France

RECRUITING

MeSH Terms

Conditions

Shock, Septic

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: May 21, 2019
• First Posted: May 23, 2019
• Study Start: July 19, 2018
• Primary Completion: September 1, 2018
• Study Completion: January 1, 2020
• Last Updated: May 23, 2019

Record last verified: 2019-05

Locations

FR (1)