Clinical trial NCT05557461: Assessment of Fluid Responsiveness in Septic Shock Patients, Can End-tidal co2 Measurement Help?
Official title: Assessment of Fluid Responsiveness in Septic Shock Patients, Can End-tidal co2 Measurement Help?, a Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Septic Shock
Hypovolemia
Sepsis
Keywords: passive leg raise
capnography
fluid therapy
echocardiography
Fluid Responsiveness
Lead sponsor: Bozyaka Training and Research Hospital
Sponsor class: OTHER
First posted: 2022-09-28
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients hospitalized in the general and reanimation intensive care units of our hospital and diagnosed with septic shock for any reason

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: end tidal co2
timeFrame: Recording will be made immediately before the passive leg raise test.
measure: end tidal co2
timeFrame: Recording will be made at the 1st minute after the end of the test.
measure: end tidal co2
timeFrame: Recording will be made 3rd minute after the end of the test.
Secondary outcomes:
measure: diastolic blood pressure
timeFrame: Recording will be made immediately before the passive leg raise test.
measure: diastolic blood pressure
timeFrame: Recording will be made at the 1st minute after the end of the test.
measure: diastolic blood pressure
timeFrame: Recording will be made 3rd minute after the end of the test.
measure: systolic blood pressure
timeFrame: Recording will be made immediately before the passive leg raise test.
measure: systolic blood pressure
timeFrame: Recording will be made at the 1st minute after the end of the test.
measure: systolic blood pressure
timeFrame: Recording will be made 3rd minute after the end of the test.
measure: ppv values
timeFrame: Recording will be made immediately before the passive leg raise test.
measure: ppv values
timeFrame: Recording will be made at the 1st minute after the end of the test.
measure: ppv values
timeFrame: Recording will be made 3rd minute after the end of the test.
measure: vci distensibility
timeFrame: Recording will be made immediately before the passive leg raise test.
measure: vci distensibility
timeFrame: Recording will be made at the 1st minute after the end of the test.
measure: vci distensibility
timeFrame: Recording will be made 3rd minute after the end of the test.
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: UHS Izmir Bozyaka Education and Research Hospital
state: Karabağlar
Study officials:
affiliation: Izmir Bozyaka Training and Research Hospital
name: Zeki T Tekgül, Assoc Prof
role: STUDY_CHAIR
affiliation: Izmir Bozyaka Training and Research Hospital
name: Özkan özmuk, MD
role: STUDY_CHAIR
affiliation: Izmir Bozyaka Training and Research Hospital
name: Çağrı Yeşilnacar, MD
role: STUDY_CHAIR
affiliation: Izmir Bozyaka Training and Research Hospital
name: Oğuz Uçar, MD
role: STUDY_CHAIR
affiliation: Izmir Bozyaka Training and Research Hospital
name: Mehmet Uğur Bilgin, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: Arango-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.
citation: Toupin 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.