Septic ShockNCT05557461
Assessment of Fluid Responsiveness in Septic Shock Patients, Can End-tidal co2 Measurement Help?
An observational study of Septic Shock and Hypovolemia, run by Bozyaka Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Fluid therapy is important in patients with sepsis and septic shock. There are many invasive and non-invasive methods to assess fluid responsiveness in patients. The specificities and sensitivities of these methods are highly variable. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septic Shock, Hypovolemia, Sepsis
- What is being tested?
- End-tifdal co2, systolic, diastolic blood pressure, ppv values and vci distensibility
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Sep 2022to 30 Mar 2023
- 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: Patients hospitalized in the general and reanimation intensive care units of our hospital and diagnosed with septic shock for any reason
Who may be able to join
- over 18 years old
- in circulatory shock
- Hemodynamically stable for 10 minutes (whether or not he takes vasoactive drugs)
- Followed in mechanical ventilation with invasive arterial monitoring
Who cannot join
- pregnant
- Heart cannot be visualized by echocardiography
- Patients for whom passive leg raise test cannot be performed
- Bilateral lower extremity amputation
- Patients who are hemodynamically unstable
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
UHS Izmir Bozyaka Education and Research Hospital
Izmir, Karabağlar, 35100
Mehmet Ugur Bilgin, +905545118874
About this study
Official title: Assessment of Fluid Responsiveness in Septic Shock Patients, Can End-tidal co2 Measurement Help?, a Prospective Observational Study
Fluid therapy is important in patients with sepsis and septic shock. There are many invasive and non-invasive methods to assess fluid responsiveness in patients. The specificities and sensitivities of these methods are highly variable. The reason for our study was to determine end-tidal co2 and fluid responsiveness in septic shock patients. The aim of the study was to evaluate the fluid response using the End-tidal CO2 difference in septic shock patients receiving intubated mechanical ventilation support.
Read the detailed description
End-tidal CO2 is a parameter that can be easily measured with our non-invasively available monitors. If results are positive, fluid response of patients can be measured with a non-invasive, easy-to-apply method.
The significance of end-tidal CO2 will be confirmed by the passive leg raise test. Assessment of fluid responsiveness with the passive leg raise test is currently seen as the non-invasive reference test used.
It has proven its accuracy and reliability in many studies. In the passive leg raise test, end-tidal CO2 will be compared between the group with and without fluid responsiveness.
Scope of the study: Patients hospitalized in the general and reanimation intensive care units of our hospital and diagnosed with septic shock for any reason.
Method(s) to be applied: All patients diagnosed with septic shock will be included in the study.
The passive leg raise test, will be applied to the patients, and cardiac output and end-tidal CO2 changes will be recorded with transthoracic echocardiography before and after.
Fluid responsiveness is considered to be present in patients whose stroke volume variation output change measured by echocardiography increases by 10% or more after the passive leg raise test.
Patients will be divided into 2 groups according to fluid responsiveness. Group-1 group with fluid responsiveness in passive leg raise test, Group-2 group with no fluid response in passive leg raise test. End-tidal CO2 will be compared between groups.
Passive leg raise test: After the patients are in a semi-sitting position (at least 2 minutes), two healthcare professionals will take the supine position and then lift their legs 45 degrees, wait for 2 minutes and return to the initial position.
With this maneuver, it is anticipated that approximately 150-300 ml of autotransfusion will be administered to the patient.
Statistical analyzes will be made with the SPSS 21 program. Normally distributed data will be expressed as mean ± standard deviation, non-normally distributed data will be expressed as median. Categorical data will be expressed as a percentage. The difference between the mean and median values will be evaluated according to the distribution of the data by Student's t or Mann-Whitney U test. Categorical data will be evaluated with the chi-square test. A p value <0.05 will be considered significant.
- Conditions
- Septic Shock, Hypovolemia, Sepsis
- Being tested
- End-tifdal co2, systolic, diastolic blood pressure, ppv values and vci distensibility
- Keywords
- passive leg raise, capnography, fluid therapy, echocardiography, Fluid Responsiveness
- Medical subject headings
- Shock, Septic, Hypovolemia, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
End-tifdal co2, systolic, diastolic blood pressure, ppv values and vci distensibilityDevice
(0,1,3,5 minutes measurements will be taken) measured before and after the test will be recorded and compared.
Cardiac output and stroke volume variation, vci distensibility will be measured and recorded by a specialist cardiologist using siemens ocuson cv70 (Siemens AG Medical Solutions, Henkestrasse, the Germany) echocardiography before and after the test.
| Study group | Role | What they receive |
|---|---|---|
| Group-1 | group with fluid responsiveness in passive leg raise test After the patients are in a semi-sitting position (at least 2 minutes), two healthcare professionals will take the supine position and then lift their legs 45 degrees, wait for 2 minutes and return to the initial position.
10% change in stroke volume will be considered positive and patients will be divided into 2 groups as fluid-responsive and non-responsive. Receives: Device: End-tifdal co2, systolic, diastolic blood pressure, ppv values and vci distensibility | |
| Group-2 | group with no fluid response in passive leg raise test After the patients are in a semi-sitting position (at least 2 minutes), two healthcare professionals will take the supine position and then lift their legs 45 degrees, wait for 2 minutes and return to the initial position.
10% change in stroke volume will be considered positive and patients will be divided into 2 groups as fluid-responsive and non-responsive. Receives: Device: End-tifdal co2, systolic, diastolic blood pressure, ppv values and vci distensibility |
What is being measured
The primary outcome is the main question the study is designed to answer.
end tidal co2
the level of carbon dioxide that is released at the end of an exhaled breath
Measured: Recording will be made immediately before the passive leg raise test.
end tidal co2
the level of carbon dioxide that is released at the end of an exhaled breath
Measured: Recording will be made at the 1st minute after the end of the test.
end tidal co2
the level of carbon dioxide that is released at the end of an exhaled breath
Measured: Recording will be made 3rd minute after the end of the test.
Secondary outcomes (12)
diastolic blood pressure
Measured: Recording will be made immediately before the passive leg raise test.
diastolic blood pressure
Measured: Recording will be made at the 1st minute after the end of the test.
diastolic blood pressure
Measured: Recording will be made 3rd minute after the end of the test.
systolic blood pressure
Measured: Recording will be made immediately before the passive leg raise test.
systolic blood pressure
Measured: Recording will be made at the 1st minute after the end of the test.
systolic blood pressure
Measured: Recording will be made 3rd minute after the end of the test.
ppv values
Pulse pressure variation
Measured: Recording will be made immediately before the passive leg raise test.
ppv values
Pulse pressure variation
Measured: Recording will be made at the 1st minute after the end of the test.
ppv values
Pulse pressure variation
Measured: Recording will be made 3rd minute after the end of the test.
vci distensibility
Distensibility Index of Inferior Vena Cava
Measured: Recording will be made immediately before the passive leg raise test.
vci distensibility
Distensibility Index of Inferior Vena Cava
Measured: Recording will be made at the 1st minute after the end of the test.
vci distensibility
Distensibility Index of Inferior Vena Cava
Measured: Recording will be made 3rd minute after the end of the test.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2022
- Study start20 Sep 2022
- Primary completion27 Feb 2023 (estimated)
- Study completion30 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- 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
- Bozyaka Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, hüseyin özkarakaş, Bozyaka Training and Research Hospital
- Investigators
- Zeki T Tekgül, Assoc Prof, Study chair, Izmir Bozyaka Training and Research HospitalÖzkan özmuk, MD, Study chair, Izmir Bozyaka Training and Research HospitalÇağrı Yeşilnacar, MD, Study chair, Izmir Bozyaka Training and Research HospitalOğuz Uçar, MD, Study chair, Izmir Bozyaka Training and Research HospitalMehmet Uğur Bilgin, MD, Study chair, Izmir Bozyaka Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05557461
- Sponsor's protocol ID
- huseyinetco2
- Status last verified
- Jan 2023
- First submitted
- 19 Aug 2022
- Last updated
- 25 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Monnet X, Marik P, Teboul JL. Passive leg raising for predicting fluid responsiveness: a systematic review and meta-analysis. Intensive Care Med. 2016 Dec;42(12):1935-1947. doi: 10.1007/s00134-015-4134-1. Epub 2016 Jan 29.
PubMed 26825952Arango-Granados MC, Zarama Cordoba V, Castro Llanos AM, Bustamante Cristancho LA. Evaluation of end-tidal carbon dioxide gradient as a predictor of volume responsiveness in spontaneously breathing healthy adults. Intensive Care Med Exp. 2018 Jul 30;6(1):21. doi: 10.1186/s40635-018-0187-0.
PubMed 30062599Toupin F, Clairoux A, Deschamps A, Lebon JS, Lamarche Y, Lambert J, Fortier A, Denault AY. Assessment of fluid responsiveness with end-tidal carbon dioxide using a simplified passive leg raising maneuver: a prospective observational study. Can J Anaesth. 2016 Sep;63(9):1033-41. doi: 10.1007/s12630-016-0677-z. Epub 2016 Jun 15.
PubMed 27307176
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Fluid Responsiveness in Septic Shock Patients, Can End-tidal co2 Measurement Help?, a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT05557461
- Acronym / sponsor ID
- huseyinetco2
- Conditions
- Septic Shock, Hypovolemia, Sepsis
- Keywords
- passive leg raise, capnography, fluid therapy, echocardiography, Fluid Responsiveness
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Bozyaka Training and Research HospitalUniversity, hospital or other
- Study start
- 20 Sep 2022 (actual)
- Primary completion
- 27 Feb 2023 (estimated)
- Study completion
- 30 Mar 2023 (estimated)
- First posted
- 28 Sep 2022 (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.
Fluid therapy is important in patients with sepsis and septic shock. There are many invasive and non-invasive methods to assess fluid responsiveness in patients. The specificities and sensitivities of these methods are highly variable. The reason for our study was to determine end-tidal co2 and fluid responsiveness in septic shock patients. The aim of the study was to evaluate the fluid response using the End-tidal CO2 difference in septic shock patients receiving intubated mechanical ventilation support.
Detailed description
End-tidal CO2 is a parameter that can be easily measured with our non-invasively available monitors. If results are positive, fluid response of patients can be measured with a non-invasive, easy-to-apply method.
The significance of end-tidal CO2 will be confirmed by the passive leg raise test. Assessment of fluid responsiveness with the passive leg raise test is currently seen as the non-invasive reference test used.
It has proven its accuracy and reliability in many studies. In the passive leg raise test, end-tidal CO2 will be compared between the group with and without fluid responsiveness.
Scope of the study: Patients hospitalized in the general and reanimation intensive care units of our hospital and diagnosed with septic shock for any reason.
Method(s) to be applied: All patients diagnosed with septic shock will be included in the study.
The passive leg raise test, will be applied to the patients, and cardiac output and end-tidal CO2 changes will be recorded with transthoracic echocardiography before and after.
Fluid responsiveness is considered to be present in patients whose stroke volume variation output change measured by echocardiography increases by 10% or more after the passive leg raise test.
Patients will be divided into 2 groups according to fluid responsiveness. Group-1 group with fluid responsiveness in passive leg raise test, Group-2 group with no fluid response in passive leg raise test. End-tidal CO2 will be compared between groups.
Passive leg raise test: After the patients are in a semi-sitting position (at least 2 minutes), two healthcare professionals will take the supine position and then lift their legs 45 degrees, wait for 2 minutes and return to the initial position.
With this maneuver, it is anticipated that approximately 150-300 ml of autotransfusion will be administered to the patient.
Statistical analyzes will be made with the SPSS 21 program. Normally distributed data will be expressed as mean ± standard deviation, non-normally distributed data will be expressed as median. Categorical data will be expressed as a percentage. The difference between the mean and median values will be evaluated according to the distribution of the data by Student's t or Mann-Whitney U test. Categorical data will be evaluated with the chi-square test. A p value <0.05 will be considered significant.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group-1 | – | Device: End-tifdal co2, systolic, diastolic blood pressure, ppv values and vci distensibilitygroup with fluid responsiveness in passive leg raise test After the patients are in a semi-sitting position (at least 2 minutes), two healthcare professionals will take the supine position and then lift their legs 45 degrees, wait for 2 minutes and return to the initial position. 10% change in stroke volume will be considered positive and patients will be divided into 2 groups as fluid-responsive and non-responsive. |
| Group-2 | – | Device: End-tifdal co2, systolic, diastolic blood pressure, ppv values and vci distensibilitygroup with no fluid response in passive leg raise test After the patients are in a semi-sitting position (at least 2 minutes), two healthcare professionals will take the supine position and then lift their legs 45 degrees, wait for 2 minutes and return to the initial position. 10% change in stroke volume will be considered positive and patients will be divided into 2 groups as fluid-responsive and non-responsive. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients hospitalized in the general and reanimation intensive care units of our hospital and diagnosed with septic shock for any reason
Key inclusion criteria (4 listed)
- over 18 years old
- in circulatory shock
- Hemodynamically stable for 10 minutes (whether or not he takes vasoactive drugs)
- Followed in mechanical ventilation with invasive arterial monitoring
Key exclusion criteria (5 listed)
- pregnant
- Heart cannot be visualized by echocardiography
- Patients for whom passive leg raise test cannot be performed
- Bilateral lower extremity amputation
- Patients who are hemodynamically unstable
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 |
|---|---|---|
| End-tifdal co2, systolic, diastolic blood pressure, ppv values and vci distensibility(0,1,3,5 minutes measurements will be taken) measured before and after the test will be recorded and compared. Cardiac output and stroke volume variation, vci distensibility will be measured and recorded by a specialist cardiologist using siemens ocuson cv70 (Siemens AG Medical Solutions, Henkestrasse, the Germany) echocardiography before and after the test. | Device | Group-1, Group-2 |
Primary outcome
end tidal co2
Time frame: Recording will be made immediately before the passive leg raise test.
the level of carbon dioxide that is released at the end of an exhaled breath
end tidal co2
Time frame: Recording will be made at the 1st minute after the end of the test.
the level of carbon dioxide that is released at the end of an exhaled breath
end tidal co2
Time frame: Recording will be made 3rd minute after the end of the test.
the level of carbon dioxide that is released at the end of an exhaled breath
12 secondary outcomes
diastolic blood pressure
Time frame: Recording will be made immediately before the passive leg raise test.
diastolic blood pressure
Time frame: Recording will be made at the 1st minute after the end of the test.
diastolic blood pressure
Time frame: Recording will be made 3rd minute after the end of the test.
systolic blood pressure
Time frame: Recording will be made immediately before the passive leg raise test.
systolic blood pressure
Time frame: Recording will be made at the 1st minute after the end of the test.
systolic blood pressure
Time frame: Recording will be made 3rd minute after the end of the test.
ppv values
Time frame: Recording will be made immediately before the passive leg raise test.
ppv values
Time frame: Recording will be made at the 1st minute after the end of the test.
ppv values
Time frame: Recording will be made 3rd minute after the end of the test.
vci distensibility
Time frame: Recording will be made immediately before the passive leg raise test.
vci distensibility
Time frame: Recording will be made at the 1st minute after the end of the test.
vci distensibility
Time frame: Recording will be made 3rd minute after the end of the test.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2023.
- Background: PubMed 26825952Monnet X, Marik P, Teboul JL. Passive leg raising for predicting fluid responsiveness: a systematic review and meta-analysis. Intensive Care Med. 2016 Dec;42(12):1935-1947. doi: 10.1007/s00134-015-4134-1. Epub 2016 Jan 29.
- Background: PubMed 30062599Arango-Granados MC, Zarama Cordoba V, Castro Llanos AM, Bustamante Cristancho LA. Evaluation of end-tidal carbon dioxide gradient as a predictor of volume responsiveness in spontaneously breathing healthy adults. Intensive Care Med Exp. 2018 Jul 30;6(1):21. doi: 10.1186/s40635-018-0187-0.
- Background: PubMed 27307176Toupin F, Clairoux A, Deschamps A, Lebon JS, Lamarche Y, Lambert J, Fortier A, Denault AY. Assessment of fluid responsiveness with end-tidal carbon dioxide using a simplified passive leg raising maneuver: a prospective observational study. Can J Anaesth. 2016 Sep;63(9):1033-41. doi: 10.1007/s12630-016-0677-z. Epub 2016 Jun 15.
- Individual participant dataSharing planned: No
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Sepsis
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.
Zeki T Tekgül, Assoc Prof study chair
Izmir Bozyaka Training and Research Hospital
Özkan özmuk, MD study chair
Izmir Bozyaka Training and Research Hospital
Çağrı Yeşilnacar, MD study chair
Izmir Bozyaka Training and Research Hospital
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 Hypovolemia, run by Bozyaka Training and Research Hospital 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 4 inclusion and 5 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 25 Jan 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hüseyin Özkarakaş, MD (5065873420 ext. +90, h.ozkarakas@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
end tidal co2 (time frame: Recording will be made immediately before the passive leg raise test.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05557461, which also lists 3 linked publications.
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 Jan 2023.