Fluid Responsiveness in Septic Shock Evaluated by Caval Ultrasound Doppler Examination - "FRIEND Study"
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Septic Shock
- Sponsor
- Charles University, Czech Republic
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Fluid responsiveness
- Last Updated
- 6 years ago
Overview
Brief 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.
Detailed 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.
Investigators
Martin Balik
A/Prof, MD, PhD
Charles University, Czech Republic
Eligibility Criteria
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%)
Outcomes
Primary Outcomes
Fluid responsiveness
Time Frame: through the study, data collection during 1 year
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.
Secondary Outcomes
- Change of flow(through the study, data collection during 1 year)
- Respiratory variation of flow velocity(through the study, data collection during 1 year)
- Respiratory collapsibility(through the study, data collection during 1 year)