Volume OverloadNCT05104528
Non-Invasive Cardiometry and Ultrasound Guided Inferior Vena Cava Collapsibility Index in Assessing Fluid Responsiveness
A study testing OSYPKA Medical ICONTM Noninvasive CardiometerTM Model C3 and Fujifilm Sonosite M-Turbo C Ultrasound system in people with Volume Overload and Tissue Perfusion, run by National Cancer Institute, Egypt at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Volume Overload, Tissue Perfusion
- What is being tested?
- OSYPKA Medical ICONTM Noninvasive CardiometerTM Model C3 and Fujifilm Sonosite M-Turbo C Ultrasound system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteEgypt
- Study dates
- 6 Sep 2021to 1 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- Lack of consent
- Active bleeding
- Age < 18yrs or > 60yrs
- Anticipated surgery or dialysis in the next 8hrs
- Aortic regurge
- Arrythmias
Show all 18Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Non-Invasive Cardiometry and Ultrasound Guided Inferior Vena Cava Collapsibility Index in Assessing Fluid Responsiveness in Septic Cancer Patients
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 .
Read the 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 .
- Conditions
- Volume Overload, Tissue Perfusion
- Being tested
- OSYPKA Medical ICONTM Noninvasive CardiometerTM Model C3, Fujifilm Sonosite M-Turbo C Ultrasound system
- Keywords
- Sepsis, IVC, IVC collapsibility index, ICU, Non-invasive cardiometry, Cancer, Critically ill
- Medical subject headings
- Edema, Sepsis, Neoplasms, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OSYPKA Medical ICONTM Noninvasive CardiometerTM Model C3Device
Also called Non-invasive cardiometry
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 systemDevice
Also called Inferior Vena Cava Collapsibility Index
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: OSYPKA Medical ICONTM Noninvasive CardiometerTM Model C3; Device: Fujifilm Sonosite M-Turbo C Ultrasound system |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 hours
Secondary outcomes (8)
Heart rate
beats per minute
Measured: 6 hours
Central Venous Pressure
mmHg
Measured: 6 hours
Mean Arterial Pressure
100 mmHg
Measured: 6 hours
Urine Output
ml/kg/hour
Measured: 6 hours
Lactate clearance
mmol/L
Measured: 6 hours
Pro-calcitonin
ng/ml
Measured: 6 hours
Inferior Vena Cava Collapsibility Index
percentage
Measured: 6 hours
Non-invasive cardiometry measurements (cardiac index)
l/min/m2
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2021
- Study start6 Sep 2021
- Primary completion1 Dec 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Volume OverloadStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Ahmed Abdellatif Hassan Gaafar, National Cancer Institute, Egypt
- Investigators
- Mohamed A Gaafar, MBBCh. MSc, Principal investigator, National Cancer Institute - Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05104528
- Sponsor's protocol ID
- AP2105-30104
- Status last verified
- Jan 2024
- First submitted
- 11 Sep 2021
- Last updated
- 17 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Non-Invasive Cardiometry and Ultrasound Guided Inferior Vena Cava Collapsibility Index in Assessing Fluid Responsiveness in Septic Cancer Patients
- ClinicalTrials.gov ID
- NCT05104528
- Acronym / sponsor ID
- AP2105-30104
- Conditions
- Volume Overload, Tissue Perfusion
- Keywords
- Sepsis, IVC, IVC collapsibility index, ICU, Non-invasive cardiometry, Cancer, Critically ill
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- National Cancer Institute, EgyptUniversity, hospital or other
- Study start
- 6 Sep 2021 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 3 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non-invasive cardiometry | Other | Device: OSYPKA Medical ICONTM Noninvasive CardiometerTM Model C3, Device: Fujifilm Sonosite M-Turbo C Ultrasound systemOSYPKA 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (18 listed)
- Lack of consent
- Active bleeding
- Age < 18yrs or > 60yrs
- Anticipated surgery or dialysis in the next 8hrs
- Aortic regurge
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OSYPKA Medical ICONTM Noninvasive CardiometerTM Model C3Also: Non-invasive cardiometryBased 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. | Device | Non-invasive cardiometry |
| Fujifilm Sonosite M-Turbo C Ultrasound systemAlso: Inferior Vena Cava Collapsibility IndexA 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. | Device | Non-invasive cardiometry |
Primary outcome
Inferior vena cava collapsibility index
Time frame: 6 hours
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.
8 secondary outcomes
Heart rate
Time frame: 6 hours
Central Venous Pressure
Time frame: 6 hours
Mean Arterial Pressure
Time frame: 6 hours
Urine Output
Time frame: 6 hours
Lactate clearance
Time frame: 6 hours
Pro-calcitonin
Time frame: 6 hours
Inferior Vena Cava Collapsibility Index
Time frame: 6 hours
Non-invasive cardiometry measurements (cardiac index)
Time frame: 6 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohamed A Gaafar, MBBCh. MSc principal investigator
National Cancer Institute - Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OSYPKA Medical ICONTM Noninvasive CardiometerTM Model C3 and Fujifilm Sonosite M-Turbo C Ultrasound system in people with Volume Overload and Tissue Perfusion, run by National Cancer Institute, Egypt at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inferior vena cava collapsibility index (time frame: 6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2024.