Clinical trial NCT02676427: Fluid Responsiveness in Septic Shock Evaluated by Caval Ultrasound Doppler Examination
Official title: Fluid Responsiveness in Septic Shock Evaluated by Caval Ultrasound Doppler Examination - "FRIEND Study"
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Septic Shock
Vein Collapsibility
Intravascular Doppler
Volume Responsiveness in Septic Shock
Lead sponsor: Charles University, Czech Republic
Sponsor class: OTHER
First posted: 2016-02-08
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 18 Years and older, mechanically ventilated ICU patients in septic shock

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.

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%)
* Intraabdominal pressure above 20 mmHg
* Open chest
* Obvious severe hypovolemia ( LVEDA\<5.5cm2/m2BSA)

Primary outcomes:
measure: Fluid responsiveness
timeFrame: through the study, data collection during 1 year
Secondary outcomes:
measure: Change of flow
timeFrame: through the study, data collection during 1 year
measure: Respiratory variation of flow velocity
timeFrame: through the study, data collection during 1 year
measure: Respiratory collapsibility
timeFrame: through the study, data collection during 1 year
measure: Respiratory collapsibility
timeFrame: through the study, data collection during 1 year
Other outcomes:
Locations:
city: Prague 2
country: Czechia
facility: Dept of Anaesthesia and Intensive Care, General University Hospital, 1st Medical Faculty, Charles University
Study officials:
References: