Fluid Responsiveness in Septic Shock Evaluated by Caval Ultrasound Doppler Examination

• Conditions: Volume Responsiveness in Septic Shock; Intravascular Doppler; Septic Shock; Vein Collapsibility

• Registration Number: NCT02676427
• Lead Sponsor: Charles University, Czech Republic

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.

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2016-02-01
• Study First Submitted QC: 2016-02-03
• Study First Posted: 2016-02-08
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-01
• Last Update Posted: 2019-08-02
• Primary Completion: 2021-05
• Study Completion: 2021-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Fluid responsiveness	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 Outcome Measures

Name	Time	Method
Change of flow	through the study, data collection during 1 year	Evaluation of fluid responsiveness by measuring a change of blood flow velocity after PLR maneuver.
Respiratory variation of flow velocity	through the study, data collection during 1 year	Evaluation of fluid responsiveness by measuring respiratory variation of blood flow velocity in left ventricular outflow tract after PLR maneuver
Respiratory collapsibility	through the study, data collection during 1 year	Evaluation of fluid responsiveness by measuring respiratory collapsibility of superior vena cava after PLR maneuver

Trial Locations

Locations (1)

Dept of Anaesthesia and Intensive Care, General University Hospital, 1st Medical Faculty, Charles University; 🇨🇿 Prague 2, Czechia