Electrical Cardiometry Compared to Transthoracic Echocardiography in Fluid Responsiveness in Sepsis

NCT03938220 | Completed

• 1 other identifier: 33017/03/19
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate the diagnostic accuracy of electrical cardiometry (EC) for the noninvasive determination of fluid responsiveness in sepsis and agreement of (EC) compared to transthoracic echocardiography (TTE).

Conditions

Electrical Cardiometry; Transthoracic Echocardiography; Fluid Responsiveness; Sepsis; Stoke Volume

Outcome Measures

Primary Outcomes (1)

• Diagnostic accuracy of electrical cardiometry to predict fluid responsiveness.

  Fluid resuscitation will be 30 mL/kg of intravenous infusion of lactated ringer to be given within the first 3 h (≈5 mL/kg/30 min) guided by fluid responsiveness (fluid responder if stroke volume increases by \> 10% after the fluid challenge). If the patient becomes fluid non-responder, vasopressor infusion (norepinephrine 0.05-0.3µg/kg/min) will start. The end of the study is when mean arterial blood pressure\> 65 mmHg (either by fluid or both fluid and vasopressor).

  24 hours

Secondary Outcomes (1)

• Agreement of electrical cardiometry with transthoracic echocardiography in the change of stroke volume before and after fluid challenge.

  24 hours

Study Arms (2)

fluid responders

fluid responder if stroke volume increases by \> 10% after the fluid challenge

Device: Electrical Cardiometry

fluid non responders

fluid responder if stroke volume increases by \<= 10% after the fluid challenge

Device: Electrical Cardiometry

Interventions

Electrical Cardiometry DEVICE

Electrical cardiometry (EC) measurements: by the ICON\_ hemodynamic monitor (ICON Cardiotronics, Inc., La Jolla, CA 92307; Osyka Medical GmbH, Berlin, and Germany, model C3, Serial no: 1725303). Four sensors of EC will be applied (1st: 5 cm above the base of the neck, 2nd: on the base of neck, 3rd: lower thorax at the level of the xiphoid and 4th: 5 cm below the 3rd electrode at the level of anterior axillary line). The ICON continuously displays HR, SV and CO.

fluid non responders; fluid responders

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This prospective cohort study will be carried out in Tanta University Hospitals at surgical ICU

You may qualify if:

• Age from 19 to 65 years old.
• Clinical criteria of sepsis \[acute change in sepsis-related organ failure assessment (SOFA) variables ≥ 2 points consequent to the infection which include: PaO2/FiO2 ratio \< 300, Glasgow Coma Scale score \< 15, mean arterial pressure (MAP) \< 70 mmHg, serum creatinine \>1.2 mg/dl or urine output \< 0.5 ml/kg/h, serum bilirubin \> 1.2 mg/dL, platelet count \< 150 X 103 /µl\].
• Developing hypotension (mean arterial blood pressure ≤ 65 mmHg).

You may not qualify if:

• Other causes of shock
• Previous cardiac disease
• Rhythm other than sinus rhythm or heart rate \> 140 beats/min
• Chronic renal failure.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University Hospitals

Tanta, ElGharbiaa, 31511, Egypt

Location

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Study Record Dates

• First Submitted: April 30, 2019
• First Posted: May 6, 2019
• Study Start: June 1, 2019
• Primary Completion: September 10, 2021
• Study Completion: September 10, 2021
• Last Updated: May 3, 2022

Record last verified: 2022-04

Locations

EG (1)