Fluid Responsiveness in Septic Shock Evaluated by Caval Ultrasound Doppler Examination (FRIEND)

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

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

Study Overview

• Status: Unknown
• Conditions: Septic Shock; Vein Collapsibility; Intravascular Doppler; Volume Responsiveness in Septic Shock
• Intervention / Treatment: Procedure: passive leg raising

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 Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

Study Locations

• Czechia
  • Prague 2, Czechia, 120 00
    • Recruiting
    • Dept of Anaesthesia and Intensive Care, General University Hospital, 1st Medical Faculty, Charles University
    • Contact: Martin Balik, A/Prof; Phone Number: +420224963366; Email: martin.balik@vfn.cz
    • Sub-Investigator: Martin Balik, MD, PhD
    • Principal Investigator: Michal Porizka, MD, PhD
    • Sub-Investigator: Miroslav Navratil, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

18 Years and older, mechanically ventilated ICU patients in septic shock

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Charles University, Czech Republic

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Anticipated): May 1, 2021
• Study Completion (Anticipated): June 1, 2021

Study Registration Dates

• First Submitted: February 1, 2016
• First Submitted That Met QC Criteria: February 3, 2016
• First Posted (Estimate): February 8, 2016

Study Record Updates

• Last Update Posted (Actual): August 2, 2019
• Last Update Submitted That Met QC Criteria: August 1, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Shock, Septic; Shock
• Other Study ID Numbers: 530/15 S-IV

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No