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

NCT05557461 | Unknown DMC

• 1 other identifier: huseyinetco2
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Septic Shock; Hypovolemia; Sepsis

Keywords

passive leg raise; capnography; fluid therapy; echocardiography; Fluid Responsiveness

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (12)

• 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.

Study Arms (2)

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

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

Interventions

End-tifdal co2, systolic, diastolic blood pressure, ppv values and vci distensibility 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-1; Group-2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bozyaka Training and Research Hospital: lead

Study Sites (1)

UHS Izmir Bozyaka Education and Research Hospital

Izmir, Karabağlar, 35100, Turkey (Türkiye)

RECRUITING

Related Publications (3)

• 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.

  PMID: 26825952 BACKGROUND

• 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.

  PMID: 30062599 BACKGROUND

• 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.

  PMID: 27307176 BACKGROUND

MeSH Terms

Conditions

Shock, Septic; Hypovolemia; Sepsis

Interventions

Blood Pressure

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

Vital Signs; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Hemodynamics; Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• 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

  STUDY CHAIR

Central Study Contacts

Hüseyin Özkarakaş, MD

CONTACT

5065873420; h.ozkarakas@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: intensive care specialist Medical Doctor

Study Record Dates

• First Submitted: August 19, 2022
• First Posted: September 28, 2022
• Study Start: September 20, 2022
• Primary Completion: February 27, 2023
• Study Completion: March 30, 2023
• Last Updated: January 25, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)