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

Volume Overload Clinical Trial

Official title:

Evaluation of Non-Invasive Cardiometry and Ultrasound Guided Inferior Vena Cava Collapsibility Index in Assessing Fluid Responsiveness in Septic Cancer Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05104528
• Other study ID #: AP2105-30104
• Status: Completed
• Phase: N/A
• Start date: September 6, 2021
• Est. completion date: December 1, 2023

Study information

• Verified date: January 2024
• Source: National Cancer Institute, Egypt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

Description:

One of the newer non-invasive methods used to assess fluid status has been the IVC collapsibility index (IVC CI) - which has shown encouraging results as a guide to fluid therapy. Studies have shown that there is an increase in CVP and decrease in IVC collapsibility with fluid replacement, as well as that both are affected by changes in intrathoracic pressure and right heart dysfunction.

measurement of (IVC CI) is calculated by ultrasound through maximum IVC diameter - minimum IVC diameter divided by minimum diameter then multiplied by 100.

if it is less than 50% means that the patient is volume non- depleted while if it is more than 50% means the reverse.

The other recent non-invasive monitoring tool is electrical cardiometry. Its idea is based on electrical impedance. The variations in impedance are calculated using an algorithm that allows measurement of the CO as well as other key haemodynamic parameters including preload (Thoracic Fluid Index), afterload (systemic vascular resistance, SVR). This has helped provide a sound guide to each individual patient's response to fluid therapy and selection of the proper cardiovascular medications and support.

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: December 1, 2023
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• ASA class I and II

• 18yrs = Age = 60yrs

• Fulfilling criteria of sepsis, as per The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3)

Exclusion Criteria:

• 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

• Severe ARDS (acute respiratory distress syndrome)

• Tense ascites

• Vasopressor infusion (before or after inclusion in the study)

Related Conditions & MeSH terms

• Tissue Perfusion
• Volume Overload

Intervention

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

Locations

Country	Name	City	State
Egypt	National Cancer Institute	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute, Egypt

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Heart rate	beats per minute	6 hours
Secondary	Central Venous Pressure	mmHg	6 hours
Secondary	Mean Arterial Pressure	100 mmHg	6 hours
Secondary	Urine Output	ml/kg/hour	6 hours
Secondary	Lactate clearance	mmol/L	6 hours
Secondary	Pro-calcitonin	ng/ml	6 hours
Secondary	Inferior Vena Cava Collapsibility Index	percentage	6 hours
Secondary	Non-invasive cardiometry measurements (cardiac index)	l/min/m2	6 hours