Septic ShockFRIENDNCT02676427
Fluid Responsiveness in Septic Shock Evaluated by Caval Ultrasound Doppler Examination
An observational study of Septic Shock and Vein Collapsibility, run by Charles University, Czech Republic at 1 site in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septic Shock, Vein Collapsibility, Intravascular Doppler
- What is being tested?
- passive leg raising
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteCzechia
- Study dates
- Sep 2015to Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 18 Years and older, mechanically ventilated ICU patients in septic shock
Who may be able to join
- 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
Who cannot join
- 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)
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- 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)
Trial locations and contacts
1 site in 1 country.
Czechia1 site, 1 recruiting
- Recruiting
Dept of Anaesthesia and Intensive Care, General University Hospital, 1st Medical Faculty, Charles University
Prague, 120 00
Martin Balik, A/Prof, +420224963366, martin.balik@vfn.cz
Martin Balik, MD, PhD
About this study
Official title: 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.
Read the 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.
- Conditions
- Septic Shock, Vein Collapsibility, Intravascular Doppler, Volume Responsiveness in Septic Shock
- Being tested
- passive leg raising
- Medical subject headings
- Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
passive leg raisingProcedure or surgery
passive leg raising under echocardiographic monitoring with intravascular doppler in place
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through the study, data collection during 1 year
Secondary outcomes (4)
Change of flow
Evaluation of fluid responsiveness by measuring a change of blood flow velocity after PLR maneuver.
Measured: 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
Measured: 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.
Measured: 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
Measured: through the study, data collection during 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2016 (estimated)
- Study startSep 2015
- Primary completionMay 2021 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- More trials run by Charles University, Czech RepublicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charles University, Czech Republic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martin Balik, Charles University, Czech Republic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02676427
- Sponsor's protocol ID
- 530/15 S-IV
- Acronym
- FRIEND
- Status last verified
- Aug 2019
- First submitted
- 1 Feb 2016
- Last updated
- 2 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fluid Responsiveness in Septic Shock Evaluated by Caval Ultrasound Doppler Examination - "FRIEND Study"
- ClinicalTrials.gov ID
- NCT02676427
- Acronym / sponsor ID
- FRIEND / 530/15 S-IV
- Conditions
- Septic Shock, Vein Collapsibility, Intravascular Doppler, Volume Responsiveness in Septic Shock
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Charles University, Czech RepublicUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- May 2021 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 8 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 18 Years and older, mechanically ventilated ICU patients in septic shock
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| passive leg raisingpassive leg raising under echocardiographic monitoring with intravascular doppler in place | Procedure or surgery | – |
Primary outcome
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.
4 secondary outcomes
Change of flow
Time frame: through the study, data collection during 1 year
Respiratory variation of flow velocity
Time frame: through the study, data collection during 1 year
Respiratory collapsibility
Time frame: through the study, data collection during 1 year
Respiratory collapsibility
Time frame: through the study, data collection during 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dept of Anaesthesia and Intensive Care, General University Hospital, 1st Medical Faculty, Charles University
Prague, Czechia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Septic Shock and Vein Collapsibility, run by Charles University, Czech Republic at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fluid responsiveness (time frame: through the study, data collection during 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2019.