ShockNCT06845280
Reliability of Respiratory Variability of Maximal Aortic Blood Flow Velocity Obtained by Ultrasonography-doppler in Patients Followed Up with a Diagnosis of Shock in Intensive Care Unit for Evaluating Fluid Responsiveness in Patients
An observational study of Shock, run by Ankara University at 1 site in Turkey (Türkiye).
Trial summary
Original value: Shock is an important cause of mortality in intensive care units (ICU). Determining whether shock patients will benefit from (intravenous) IV fluid therapy is possible by fluid responsiveness parameters/tests. More than half of the patients being monitored for shock in the ICU are not fluid responders. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shock
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Feb 2025to Apr 2026
- How long will I take part?
- 15 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Shock patients monitored in intensive care
Who may be able to join
- Age over 18 years old
- Being admitted to medical intensive care unit of Ankara University Faculty of Medicine
- Having a diagnosis of shock
- Deteriorating shock state after the initial 6 hour despite optimal treatment
- Patients or their relatives are required to read, understand and sign the informed consent form for participation in the study.
- Patients who are expected to stay in intensive care for at least 48 hours
Who cannot join
- The patient has an identified pregnancy or suspected pregnancy.
- Presence of thrombocytopenia that may prevent catheter placement (platelet count less than 50 thousand/mm3 and not being able to be increased)
- Prolongation of prothrombin time that may prevent catheter placement
- Prolongation of activated partial thromboplastin time that may prevent catheter placement
- Failure to provide jugular or subclavian central venous catheterization
- Clinical conditions that prevent the insertion of an arterial thermistor catheter (edema, hematoma, thrombosis, signs of active infection in the area where the catheter will be inserted) and the inability to insert an arterial thermistor catheter
Show all 10Show fewer
- The patient is receiving CRRT (Continuous renal replacement therapy)/ECMO (Extracorporeal membrane oxygenation)
- Contraindications to passive leg raising test (axial fractures, intra-abdominal hypertension, increased intra-abdominal pressure, lower extremity amputation)
- Presence of conditions preventing bedside USG (chest wall deformity, inability to position the patient appropriately, inadequate image quality, open wound, infection or dressing on the chest wall preventing transthoracic USG)
- Objection of patients' intensivist to enroll the patient (with a documented reason)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Ankara University Faculty of Medicine Ibn'i Sina Hospital
Ankara, TR, 06230
Uğur Özdemir, +905383731764, ugurozdemir@ankara.edu.tr
About this study
Original value: Shock is an important cause of mortality in intensive care units (ICU). Determining whether shock patients will benefit from (intravenous) IV fluid therapy is possible by fluid responsiveness parameters/tests. More than half of the patients being monitored for shock in the ICU are not fluid responders. Especially in patients who do not have the desired response despite appropriate shock treatment for the first 6 hours, continuing IV bolus fluid treatments without performing fluid responsiveness tests may cause an increase in mortality due to hypervolemia and organ edema. Today, these tests can be measured with transpulmonary thermodilution (TPTD) devices. Calibration, installation and evaluation of the device requires expert personnel and its use can cause a significant increase in intensive care workload. Instead of this minimal invasive approach, the respiratory variability of maximal aortic blood flow rate (ΔVaortmax), which can be obtained non-invasively with the use of bedside ultrasonography (USG), can be used as a fluid responsiveness parameter. There is no study on the value of this parameter in adult intensive care patients. Revealing the importance of this parameter as a fluid responsiveness parameter may pave the way for ultrasonography devices, which are already in use with other indications, to be used as an important advanced hemodynamic monitoring tool. For this purpose, this prospective observational study was planned.
Method: This study was planned to be conducted on non-pregnant shock patients who are greater than 18 years and who were admitted to Medical ICU of Ankara University Faculty of Medicine, Department of Internal Medicine Division of Intensive Care. It was planned to establish the TPTD system, which is a standard practice in patients whose shock symptoms did not improve and whose lactate level did not decrease despite appropriate fluid, vasopressor and standard intensive care applications for the first 6 hours, and to compare the fluid responsiveness parameters obtained from this TPTD system with the ΔVaortmax obtained by bedside USG. Within the scope of a 6-12 month study period, it is planned to perform advanced hemodynamic monitoring with TPTD in 60 patients and to compare the obtained measurements with ΔVaortmax measurements with bedside USG. In order to carry out the project, a TPTD device and its thermodilution catheters as well as a standard ultrasonography device with an echocardiography system are needed.
Read more
Management: Patients who are admitted with shock to our ICU and who develop shock state during their admission will be evaluated for eligibility for the study. A TPTD system will be installed in patients eligible for the study, and a bedside USG will be performed simultaneously and fluid responsiveness and other clinical and hemodynamic data will be recorded. Data will be analyzed to evaluate whether ΔVaortmax, is a good fluid responsiveness parameter for adult shock patients and to determine a cutoff value to assign volume responsive patients.
Widespread effect: With this project, USG/echocardiography devices, which are already commonly used in ICU's for various purposes, will find a new use as advanced hemodynamic monitoring tools to determine fluid responsiveness during shock states, without incurring additional risks to patiens with minimal additional costs. Importantly, this method may reduce the need for some minimally invasive methods such as transpulmonary thermodilution. The results of our project will be disseminated through oral presentations and articles.
- Conditions
- Shock
- Keywords
- Shock, intensive care, transpulmonary thermodilution, echocardiography
- Medical subject headings
- Shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Shock patients | Critically ill shock patients who require at least 0.2mcg/kg/min noradrenaline, or have lactate levels >4 mEq/L and whose clinical tissue perfusion parameters are deteriorating despite adequate treatment for 6 hours (increasing lactate levels, mottling score, decreasing consciousness... ) will be evaluated for eligibility. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory variability of maximal aortic blood flow
To compare respiratory variability of maximal aortic blood flow obtained by transthoracic echocardiography with fluid responsiveness parameters obtained by transpulmonary thermodilution.
Measured: maxiumum 5 days
Secondary outcomes (1)
Mortality
To investigate the relationship between fluid responsiveness measurements and mortality.
Measured: Mortality event up to first month after the hemodynamic measurements will be monitored.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2025
- Study startFeb 2025 (estimated)
- Primary completionJan 2026 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ShockStudies of the same condition, open and under way.
- More trials run by Ankara UniversityThe 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)
- Target duration
- 15 Days
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Principal investigator, Uğur Özdemir, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06845280
- Sponsor's protocol ID
- 223S949
- Status last verified
- Feb 2025
- First submitted
- 27 Dec 2024
- Last updated
- 25 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Ethics committee will be consulted
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability of Respiratory Variability of Maximal Aortic Blood Flow Velocity Obtained by Ultrasonography-doppler in Patients Followed Up with a Diagnosis of Shock in Intensive Care Unit for Evaluating Fluid Responsiveness in Patients
- ClinicalTrials.gov ID
- NCT06845280
- Acronym / sponsor ID
- 223S949
- Conditions
- Shock
- Keywords
- Shock, intensive care, transpulmonary thermodilution, echocardiography
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- Feb 2025 (estimated)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 25 Feb 2025 (actual)
- 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.
Original value: Shock is an important cause of mortality in intensive care units (ICU). Determining whether shock patients will benefit from (intravenous) IV fluid therapy is possible by fluid responsiveness parameters/tests. More than half of the patients being monitored for shock in the ICU are not fluid responders. Especially in patients who do not have the desired response despite appropriate shock treatment for the first 6 hours, continuing IV bolus fluid treatments without performing fluid responsiveness tests may cause an increase in mortality due to hypervolemia and organ edema. Today, these tests can be measured with transpulmonary thermodilution (TPTD) devices. Calibration, installation and evaluation of the device requires expert personnel and its use can cause a significant increase in intensive care workload. Instead of this minimal invasive approach, the respiratory variability of maximal aortic blood flow rate (ΔVaortmax), which can be obtained non-invasively with the use of bedside ultrasonography (USG), can be used as a fluid responsiveness parameter. There is no study on the value of this parameter in adult intensive care patients. Revealing the importance of this parameter as a fluid responsiveness parameter may pave the way for ultrasonography devices, which are already in use with other indications, to be used as an important advanced hemodynamic monitoring tool. For this purpose, this prospective observational study was planned.
Method: This study was planned to be conducted on non-pregnant shock patients who are greater than 18 years and who were admitted to Medical ICU of Ankara University Faculty of Medicine, Department of Internal Medicine Division of Intensive Care. It was planned to establish the TPTD system, which is a standard practice in patients whose shock symptoms did not improve and whose lactate level did not decrease despite appropriate fluid, vasopressor and standard intensive care applications for the first 6 hours, and to compare the fluid responsiveness parameters obtained from this TPTD system with the ΔVaortmax obtained by bedside USG. Within the scope of a 6-12 month study period, it is planned to perform advanced hemodynamic monitoring with TPTD in 60 patients and to compare the obtained measurements with ΔVaortmax measurements with bedside USG. In order to carry out the project, a TPTD device and its thermodilution catheters as well as a standard ultrasonography device with an echocardiography system are needed.
Management: Patients who are admitted with shock to our ICU and who develop shock state during their admission will be evaluated for eligibility for the study. A TPTD system will be installed in patients eligible for the study, and a bedside USG will be performed simultaneously and fluid responsiveness and other clinical and hemodynamic data will be recorded. Data will be analyzed to evaluate whether ΔVaortmax, is a good fluid responsiveness parameter for adult shock patients and to determine a cutoff value to assign volume responsive patients.
Widespread effect: With this project, USG/echocardiography devices, which are already commonly used in ICU's for various purposes, will find a new use as advanced hemodynamic monitoring tools to determine fluid responsiveness during shock states, without incurring additional risks to patiens with minimal additional costs. Importantly, this method may reduce the need for some minimally invasive methods such as transpulmonary thermodilution. The results of our project will be disseminated through oral presentations and articles.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 15 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Shock patients | – | –Critically ill shock patients who require at least 0.2mcg/kg/min noradrenaline, or have lactate levels >4 mEq/L and whose clinical tissue perfusion parameters are deteriorating despite adequate treatment for 6 hours (increasing lactate levels, mottling score, decreasing consciousness... ) will be evaluated for eligibility. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Shock patients monitored in intensive care
Key inclusion criteria (6 listed)
- Age over 18 years old
- Being admitted to medical intensive care unit of Ankara University Faculty of Medicine
- Having a diagnosis of shock
- Deteriorating shock state after the initial 6 hour despite optimal treatment
- Patients or their relatives are required to read, understand and sign the informed consent form for participation in the study.
Key exclusion criteria (10 listed)
- The patient has an identified pregnancy or suspected pregnancy.
- Presence of thrombocytopenia that may prevent catheter placement (platelet count less than 50 thousand/mm3 and not being able to be increased)
- Prolongation of prothrombin time that may prevent catheter placement
- Prolongation of activated partial thromboplastin time that may prevent catheter placement
- Failure to provide jugular or subclavian central venous catheterization
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Respiratory variability of maximal aortic blood flow
Time frame: maxiumum 5 days
To compare respiratory variability of maximal aortic blood flow obtained by transthoracic echocardiography with fluid responsiveness parameters obtained by transpulmonary thermodilution.
1 secondary outcome
Mortality
Time frame: Mortality event up to first month after the hemodynamic measurements will be monitored.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2025.
- Individual participant dataSharing planned: Undecided. Ethics committee will be consulted
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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.
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 Shock, run by Ankara University at 1 site in Turkey (Türkiye).
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 6 inclusion and 10 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: opening soon, as of the sponsor's last update on 25 Feb 2025. 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 Turkey (Türkiye). 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Uğur Özdemir, Academic (+905383731764, ugurozdemir@ankara.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory variability of maximal aortic blood flow (time frame: maxiumum 5 days). 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 25 Feb 2025.