Fluid Responsiveness in Septic Shock Evaluated by Caval Ultrasound Doppler Examination
FRIEND
1 other identifier
observational
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Sep 2015
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2015
CompletedFirst Submitted
Initial submission to the registry
February 1, 2016
CompletedFirst Posted
Study publicly available on registry
February 8, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2021
CompletedAugust 2, 2019
August 1, 2019
5.7 years
February 1, 2016
August 1, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
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
Respiratory collapsibility
through the study, data collection during 1 year
Interventions
passive leg raising under echocardiographic monitoring with intravascular doppler in place
Eligibility Criteria
18 Years and older, mechanically ventilated ICU patients in septic shock
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dept of Anaesthesia and Intensive Care, General University Hospital, 1st Medical Faculty, Charles University
Prague, 120 00, Czechia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- A/Prof, MD, PhD
Study Record Dates
First Submitted
February 1, 2016
First Posted
February 8, 2016
Study Start
September 1, 2015
Primary Completion
May 1, 2021
Study Completion
June 1, 2021
Last Updated
August 2, 2019
Record last verified: 2019-08
Data Sharing
- IPD Sharing
- Will not share