Assessment of Fluid Responsiveness in Septic Shock Patients, Can End-tidal co2 Measurement Help?

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.

Study Overview

• Status: Recruiting
• Conditions: Sepsis; Septic Shock; Hypovolemia
• Intervention / Treatment: Device: End-tifdal co2, systolic, diastolic blood pressure, ppv values and vci distensibility

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 Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

• Study Contact: Name: Hüseyin Özkarakaş, MD; Phone Number: +90 5065873420; Email: h.ozkarakas@hotmail.com

Study Locations

• Turkey
  • Karabağlar
    • Izmir, Karabağlar, Turkey, 35100
      • Recruiting
      • UHS Izmir Bozyaka Education and Research Hospital
      • Contact: Mehmet Ugur Bilgin; Phone Number: +905545118874

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	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.
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
end tidal co2	the level of carbon dioxide that is released at the end of an exhaled breath	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	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	Recording will be made 3rd minute after the end of the test.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
diastolic blood pressure		Recording will be made immediately before the passive leg raise test.
diastolic blood pressure		Recording will be made at the 1st minute after the end of the test.
diastolic blood pressure		Recording will be made 3rd minute after the end of the test.
systolic blood pressure		Recording will be made immediately before the passive leg raise test.
systolic blood pressure		Recording will be made at the 1st minute after the end of the test.
systolic blood pressure		Recording will be made 3rd minute after the end of the test.
ppv values	Pulse pressure variation	Recording will be made immediately before the passive leg raise test.
ppv values	Pulse pressure variation	Recording will be made at the 1st minute after the end of the test.
ppv values	Pulse pressure variation	Recording will be made 3rd minute after the end of the test.
vci distensibility	Distensibility Index of Inferior Vena Cava	Recording will be made immediately before the passive leg raise test.
vci distensibility	Distensibility Index of Inferior Vena Cava	Recording will be made at the 1st minute after the end of the test.
vci distensibility	Distensibility Index of Inferior Vena Cava	Recording will be made 3rd minute after the end of the test.

Collaborators and Investigators

• Sponsor: Bozyaka Training and Research Hospital
• Investigators: Study Chair: Zeki T Tekgül, Assoc Prof, Izmir Bozyaka Training and Research Hospital; Study Chair: Özkan özmuk, MD, Izmir Bozyaka Training and Research Hospital; Study Chair: Çağrı Yeşilnacar, MD, Izmir Bozyaka Training and Research Hospital; Study Chair: Oğuz Uçar, MD, Izmir Bozyaka Training and Research Hospital; Study Chair: Mehmet Uğur Bilgin, MD, Izmir Bozyaka Training and Research Hospital

Publications and helpful links

General 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2022
• Primary Completion (Anticipated): February 27, 2023
• Study Completion (Anticipated): March 30, 2023

Study Registration Dates

• First Submitted: August 19, 2022
• First Submitted That Met QC Criteria: September 27, 2022
• First Posted (Actual): September 28, 2022

Study Record Updates

• Last Update Posted (Actual): January 25, 2023
• Last Update Submitted That Met QC Criteria: January 23, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: capnography; echocardiography; passive leg raise; fluid therapy; Fluid Responsiveness
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Shock, Septic; Shock; Hypovolemia
• Other Study ID Numbers: huseyinetco2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No