Clinical trial NCT05104528: Non-Invasive Cardiometry and Ultrasound Guided Inferior Vena Cava Collapsibility Index in Assessing Fluid Responsiveness
Official title: Evaluation of Non-Invasive Cardiometry and Ultrasound Guided Inferior Vena Cava Collapsibility Index in Assessing Fluid Responsiveness in Septic Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Volume Overload
Tissue Perfusion
Keywords: Sepsis
IVC
IVC collapsibility index
ICU
Non-invasive cardiometry
Cancer
Critically ill
Lead sponsor: National Cancer Institute, Egypt
Sponsor class: OTHER
First posted: 2021-11-03
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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 .

Detailed 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 .

Eligibility criteria: 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)

Primary outcomes:
measure: Inferior vena cava collapsibility index
timeFrame: 6 hours
Secondary outcomes:
measure: Heart rate
timeFrame: 6 hours
measure: Central Venous Pressure
timeFrame: 6 hours
measure: Mean Arterial Pressure
timeFrame: 6 hours
measure: Urine Output
timeFrame: 6 hours
measure: Lactate clearance
timeFrame: 6 hours
measure: Pro-calcitonin
timeFrame: 6 hours
measure: Inferior Vena Cava Collapsibility Index
timeFrame: 6 hours
measure: Non-invasive cardiometry measurements (cardiac index)
timeFrame: 6 hours
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: National Cancer Institute
Study officials:
affiliation: National Cancer Institute - Cairo University
name: Mohamed A Gaafar, MBBCh. MSc
role: PRINCIPAL_INVESTIGATOR
References: