An observational study in Septic Shock, Hypovolemia and Sepsis, sponsored by Bozyaka Training and Research Hospital. Status unknown at 1 site in Turkey. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-01-25.
Sponsored by Bozyaka Training and Research Hospital · Observational
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.
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.
862 studies on the registry are indexed under Shock, Septic; 207 are open to participants now.
This study's planned enrollment of 60 is below the median of 100 across 298 observational studies indexed under Shock, Septic.
Browse Shock, Septic studies →Bozyaka Training and Research Hospital is the lead sponsor of 50 studies on the registry; 5 are open to participants now.
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Patients hospitalized in the general and reanimation intensive care units of our hospital and diagnosed with septic shock for any reason
Exclusion Criteria:
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.
Device: End-tifdal co2, systolic, diastolic blood pressure, ppv values and vci distensibility
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.
Device: 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.
end tidal co2
the level of carbon dioxide that is released at the end of an exhaled breath
Time frame: 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
Time frame: 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
Time frame: Recording will be made 3rd minute after the end of the test.
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
Pulse pressure variation
Time frame: Recording will be made immediately before the passive leg raise test.
ppv values
Pulse pressure variation
Time frame: Recording will be made at the 1st minute after the end of the test.
ppv values
Pulse pressure variation
Time frame: Recording will be made 3rd minute after the end of the test.
vci distensibility
Distensibility Index of Inferior Vena Cava
Time frame: Recording will be made immediately before the passive leg raise test.
vci distensibility
Distensibility Index of Inferior Vena Cava
Time frame: Recording will be made at the 1st minute after the end of the test.
vci distensibility
Distensibility Index of Inferior Vena Cava
Time frame: Recording will be made 3rd minute after the end of the test.
Plan to share: No
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Bozyaka Training and Research Hospital