Non-Invasive Cardiometry and Ultrasound Guided Inferior Vena Cava Collapsibility Index in Assessing Fluid Responsiveness

NCT05104528 | Completed DMC

• 1 other identifier: AP2105-30104
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

43 patients between 18-60 years presenting with criteria of sepsis (life-threatening organ dysfunction caused by a dysregulated host response to infection, suspected or documented infection and an acute increase ≥2 SOFA \[Sequential Organ Failure Assessment\] points) will be enrolled in our study. Approval of the ethical committee and informed written consent from first degree relatives will be issued. They will be given a full and detailed explanation of the intended study protocol and will be informed about the potential benefits of the development of a successful technique as well as the potential side-effects. To compare the efficacy of non-invasive cardiometry and ultrasound (US) guided inferior vena cava (IVC) collapsibility when assessing the response of septic patients to fluid therapy guidelines of The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3); in the first six hours of ICU admission .

Conditions

Volume Overload; Tissue Perfusion

Keywords

Sepsis; IVC; IVC collapsibility index; ICU; Non-invasive cardiometry; Cancer; Critically ill

Outcome Measures

Primary Outcomes (1)

• Inferior vena cava collapsibility index

  The ultrasound guided IVC collapsibility index will be correlated with to the cardiac index determined by the non-invasive cardiometry to determine which is more effective.

  6 hours

Secondary Outcomes (8)

• Heart rate

  6 hours

• Central Venous Pressure

  6 hours

• Mean Arterial Pressure

  6 hours

• Urine Output

  6 hours

• Lactate clearance

  6 hours

Study Arms (1)

Non-invasive cardiometry

OTHER

OSYPKA Medical ICONTM Noninvasive CardiometerTM Model C3 A technique for the non-invasive determination of SV, CO, cardiac index, stroke index and HR along with other hemodynamic parameters such as preload (Thoracic Fluid Index), afterload and others. The changes of impedance over time are integrated in a complex algorithm that allows to measure CO and the other above-mentioned parameters.

Device: OSYPKA Medical ICONTM Noninvasive CardiometerTM Model C3; Device: Fujifilm Sonosite M-Turbo C Ultrasound system

Interventions

OSYPKA Medical ICONTM Noninvasive CardiometerTM Model C3 DEVICE

Based on its precedent electrical impedance. 4 electrodes are placed on the patient: 2 on the left of the neck and the other 2 on the left lower chest . A low magnitude (2 mA), high frequency (30-100 KHz) alternating electrical current (AC) of constant amplitude is applied through the outer electrodes, and the resulting voltage is received by the inner electrodes. The ratio of the detected voltage to the applied current is the bio-impedance. The principle on which this is based is that during systole, red blood cells flow in a parallel manner, which allows the electrical current to flow easily thereby improving the electrical velocity and decreasing impedance. While during diastole, RBCs are randomly arranged, consequently hindering the electrical current (increased impedance) and decreasing electrical velocimetry. The changes of impedance over time are integrated in a complex algorithm that allows to measure CO and the other parameters.

Also known as: Non-invasive cardiometry

Non-invasive cardiometry

Fujifilm Sonosite M-Turbo C Ultrasound system DEVICE

A low-frequency phased array transducer (3.5-5 MHz) will be used to assess the IVC, which lies in the retroperitoneum, to the right of aorta. At or near the junction with the hepatic veins, we will measure the IVC diameter. To properly visualise the IVC, the probe will be inserted in the subxiphoid 4-chamber position with the probe marker oriented vertically to find the right ventricle and atrium. We will see the convergence of the IVC with the right atrium as the probe is progressively aimed towards the spine. We will then follow the IVC inferiorly, to detect the meeting of the hepatic veins with the IVC. M-mode Doppler sonography of the IVC will be used to graphically document the absolute size and dynamic changes in the calibre of the vessel during inspiration and expiration. After the visualisation of the IVC, we will freeze the US screen, and using the caliper function on the US machine, maximum and minimum diameters of the IVC will be documented.

Also known as: Inferior Vena Cava Collapsibility Index

Non-invasive cardiometry

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• ASA class I and II
• yrs ≥ Age ≤ 60yrs
• Fulfilling criteria of sepsis, as per The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3)

You may not qualify if:

• Lack of consent
• Active bleeding
• Age \< 18yrs or \> 60yrs
• Anticipated surgery or dialysis in the next 8hrs
• Aortic regurge
• Arrythmias
• Cardiac tamponade
• Chest wall oedema
• Child B and Child C hepatic patients
• Congestive heart failure
• End-stage kidney disease (ESKD) patients with a creatinine clearance (CrCl) \<50ml/min
• Massive bilateral pleural effusion
• Mechanical ventilation
• More than 4hrs after meeting criteria of septic shock
• New York Heart Association (NYHA) III and IV cardiac patients

Sponsors & Collaborators

• National Cancer Institute, Egypt: lead

Study Sites (1)

National Cancer Institute

Cairo, 11796, Egypt

Location

MeSH Terms

Conditions

Edema; Sepsis; Neoplasms; Critical Illness

Condition Hierarchy (Ancestors)

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

Study Officials

• Mohamed A Gaafar, MBBCh. MSc

  National Cancer Institute - Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 11, 2021
• First Posted: November 3, 2021
• Study Start: September 6, 2021
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: January 17, 2024

Record last verified: 2024-01

Locations

EG (1)