Fluid Responsiveness in Septic Shock Evaluated by Caval Ultrasound Doppler Examination

Septic Shock Clinical Trial

— FRIEND  

Official title:

Fluid Responsiveness in Septic Shock Evaluated by Caval Ultrasound Doppler Examination - "FRIEND Study"

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02676427
• Other study ID #: 530/15 S-IV
• Status: Recruiting
• Start date: September 2015
• Est. completion date: June 2021

Study information

• Verified date: August 2019
• Source: Charles University, Czech Republic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The study aims at clarification of venous collapsibility measures with real venous flow measurements during dynamic maneuver testing fluid responsiveness in septic shock patients.

Description:

Sedated and mechanically ventilated patients in septic shock will be enrolled in the study. A fine catheter with ultrasound doppler probe will be introduced into the central venous catheter already in place in superior vena cava. Doppler signal will be evaluated by console prototype (NILUS Medical) and continuous analysis of blood flow velocity respiratory variation will be performed. These values will be compared to standard hemodynamic monitoring parameters (central venous and arterial pressures) and to parameters acquired by transoesophageal (TOE) and transthoracic echocardiography.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 2021
• Est. primary completion date: May 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients in severe sepsis or septic shock

• intubation and mechanical ventilation

• sedated patient without spontaneous respiratory efforts

• central venous catheter in place inserted via right internal jugular vein

• signed informed consent by family members

Exclusion Criteria:

• superior vena cava vascular anomaly

• irradiation of neck or mediastinum in medical history

• thrombosis of superior vena cava in medical history

• atrial fibrillation or other irregular rhythm

• permanent or external pacemaker

• aggressive mechanical ventilation (PEEP above 10 cm H2O, Pmax above 30 cm H2O)

• TOE contraindication (oesophageal varices, stricture, tumour, upper gastrointestinal bleeding)

• Pericardial effusion, constrictive pericarditis

• Moderate or severe valvular lesion

• Severe systolic dysfunction of the left (EF less than 30%) or right ventricle (FAC less than 25%)

• Intraabdominal pressure above 20 mmHg

• Open chest

• Obvious severe hypovolemia ( LVEDA<5.5cm2/m2BSA)

Related Conditions & MeSH terms

• Intravascular Doppler
• Septic Shock
• Shock
• Shock, Septic
• Vein Collapsibility
• Volume Responsiveness in Septic Shock

Intervention

Procedure:
• passive leg raising
passive leg raising under echocardiographic monitoring with intravascular doppler in place

Locations

Country	Name	City	State
Czechia	Dept of Anaesthesia and Intensive Care, General University Hospital, 1st Medical Faculty, Charles University	Prague 2

Sponsors (1)

Lead Sponsor	Collaborator
Charles University, Czech Republic

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fluid responsiveness	Evaluation of fluid responsiveness, defined as 15% increase of cardiac output after reversible fluid challenge (using PLR - passive leg raise maneuver), by ultrasound doppler evaluation of superior vena caval blood flow respiratory variation.	through the study, data collection during 1 year
Secondary	Change of flow	Evaluation of fluid responsiveness by measuring a change of blood flow velocity after PLR maneuver.	through the study, data collection during 1 year
Secondary	Respiratory variation of flow velocity	Evaluation of fluid responsiveness by measuring respiratory variation of blood flow velocity in left ventricular outflow tract after PLR maneuver	through the study, data collection during 1 year
Secondary	Respiratory collapsibility	Evaluation of fluid responsiveness by measuring respiratory collapsibility of inferior vena cava after PLR maneuver.	through the study, data collection during 1 year
Secondary	Respiratory collapsibility	Evaluation of fluid responsiveness by measuring respiratory collapsibility of superior vena cava after PLR maneuver	through the study, data collection during 1 year