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

NCT ID: NCT05557461

Last Updated: 2023-01-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-09-20

Study Completion Date

2023-03-30

Brief Summary

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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

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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

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Septic Shock Hypovolemia Sepsis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

End-tifdal co2, systolic, diastolic blood pressure, ppv values and vci distensibility

Intervention Type DEVICE

(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.

End-tifdal co2, systolic, diastolic blood pressure, ppv values and vci distensibility

Intervention Type DEVICE

(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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bozyaka Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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hüseyin özkarakaş

intensive care specialist Medical Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zeki T Tekgül, Assoc Prof

Role: STUDY_CHAIR

Izmir Bozyaka Training and Research Hospital

Özkan özmuk, MD

Role: STUDY_CHAIR

Izmir Bozyaka Training and Research Hospital

Çağrı Yeşilnacar, MD

Role: STUDY_CHAIR

Izmir Bozyaka Training and Research Hospital

Oğuz Uçar, MD

Role: STUDY_CHAIR

Izmir Bozyaka Training and Research Hospital

Mehmet Uğur Bilgin, MD

Role: STUDY_CHAIR

Izmir Bozyaka Training and Research Hospital

Locations

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UHS Izmir Bozyaka Education and Research Hospital

Izmir, Karabağlar, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Hüseyin Özkarakaş, MD

Role: CONTACT

5065873420 ext. +90

Facility Contacts

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Mehmet Ugur Bilgin

Role: primary

+905545118874

References

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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.

Reference Type BACKGROUND
PMID: 26825952 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30062599 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27307176 (View on PubMed)

Other Identifiers

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huseyinetco2

Identifier Type: -

Identifier Source: org_study_id

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