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Coronary Bypass StenosisNCT05945303

Correlation Between Internal Jugular Vein Ultrasound and Electrical Cardiometry

A study testing Coronary Artery Bypass Grafting surgery in people with Coronary Bypass Stenosis and Coronary Artery Bypass Grafting Surgery, run by Egymedicalpedia at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Coronary artery bypass graft (CABG) surgery is one of the most frequently performed cardiac surgery procedures worldwide. CABG has been used for more than 40 years to relieve symptoms and to reduce the risk of death in patients with ischemic heart disease. Read more about this study

Who is it for?
Ages 18 to 60 years
What is being tested?
Coronary Artery Bypass Grafting surgery
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteEgypt
Study dates
1 Mar 2023to 30 Aug 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
  • No healthy volunteers
  • Adult

Who may be able to join

  • Adult patients (above 18 years old to be able to provide advanced informed consent Planned for elective CABG surgery) both male and female will be included in the study

Who cannot join

  • Severely reduced preoperative left ventricular ejection fraction (< 40 %).
  • Patients who will develop any complication after fluid infusion as pulmonary edema and heart failure will be excluded from the study.
  • Significant cardiac arrhythmia.
  • Significant valvular heart disease.
  • Clinically evident pulmonary disease.
  • Bilaterally inserted venous catheters (jugular or subclavian vein).
  • History of radiotherapy or surgery of the neck region.
  • Inability to obtain interpretable ultrasound images due to a difficult acoustic window.

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Al-Azhar University hospitals

    Cairo

Other trials in Egypt

About this study

Official title: Correlation Between Internal Jugular Vein Ultrasound and Electrical Cardiometry in Assessment of Fluid Responsiveness in Patients Undergoing Coronary Artery Bypass Grafting Surgery

Coronary artery bypass graft (CABG) surgery is one of the most frequently performed cardiac surgery procedures worldwide. CABG has been used for more than 40 years to relieve symptoms and to reduce the risk of death in patients with ischemic heart disease.

Read the detailed description

Cardiopulmonary bypass can produce changes in fluid physiology and fluid responsiveness in patients characterized by increased interstitial fluid as a consequence of decreased cardiac output and inflammatory changes. This shift of fluid from intravascular space to the intrtstitial space, in addition to blood and fluid losses during the surgical procedure can result in an intravascular hypovolemia that requires fluid resuscitation.

Fluid management is one of the most important treatments for stabilizing hemodynamics in patients during and after cardiac surgery. Hypovolemia may leads to inadequate organ perfusion, whereas fluid overload may lead to postoperative complications such as congestive heart failure or pulmonary edema, In addition to patients who underwent cardiac surgery have a certain degree of myocardial stunning and hence cautions should be taken regarding fluid management in patients with limited cardiac reserve.

Fluid responsiveness (FR) is generally defined as an increase of 10-15% in stroke volume (SV), cardiac output (CO), or cardiac index (CI) in response to volume expansion and indicates unmasked hypovolemia or preload dependacy.

The methods for assessing fluid responsiveness have been evolved from static and volume parameters such as central venous pressure (CVP), pulmonary artery occlusion pressure (PAOP), inferior vena cava (IVC) and superior vena cava (SVC) diameters, right ventricular end-diastolic volume and right ventricular end-diastolic volume, which are unable to predict fluid responsiveness to dynamic indices such as pulse pressure variation (PPV),stroke volume variation (SVV), Pleth variability index (PVI) and aortic blood flow which is based on heart-lung interactions during mechanical ventilation, which have amodest degree of accuracy.

Techniques based on either a virtual or real fluid challenge such as passive led raising (PLR) and rapid fluid challenge (100-250cc) have a high degree of accuracy in predicting fluid responsiveness.

Over the last decade, a number of studies have used heart-lung interactions during mechanical ventilation to assess fluid responsiveness; specifically pulse pressuer variation (PPV) derived from analysis of the arterial blood pressure wave form, stroke volume variation (SVV) derived from pulse-contour analysis (measured by lithium dilution cardiac output monitoring system (LiDDCO) or pulse index continuous cardiac output monitoring system (PiCCO), and the variation of the amplitude of the pulse oximter plethysmographic waveform have been shown to be highly predictive of fluid responsiveness.

However, dynamic parameters are unreliable during spontaneous breathing activity. To overcome the limited accuracy of these hemodynamic parameters in this specific clinical scenario, a passive leg raising (PLR) manoeuver has been suggested to be reliable predictor of fluid responsiveness during spontaneous breathing.

SVV can be monitored with the PiCCO system requiring transpulmonary thermodilution,It is an invasive procedure requires the venous access and balloon flotation of the catheter through the right side.

Accordingly, there are complications associated with detection with this system, and some are even fatal. Furthermore, this system requires an elaborate protocol for intermittent injections into pulmonary artery catheter thermodilution.

Being tested
Coronary Artery Bypass Grafting surgery

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Coronary Artery Bypass Grafting surgeryProcedure or surgery

    Assessing the reliability of predicting fluid responsiveness in adults undergoing coronary artery bypass graft surgery using ultrasonography of the internal jugular vein for assessment of vessel distensibilty in relation to stroke volume variation (SVV) measured by electrical cardiometry.

Study groups in NCT05945303
Study groupRoleWhat they receive
Responder groupExperimentalAbout 20 Adult patients Planned for elective CABG surgery
Receives: Procedure: Coronary Artery Bypass Grafting surgery
Not Responder groupExperimentalAbout 20 Adult patients Planned for elective CABG surgery
Receives: Procedure: Coronary Artery Bypass Grafting surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Reliability of predicting fluid responsiveness

    to assess the reliability of predicting fluid responsiveness in adults undergoing coronary artery bypass graft surgery using ultrasonography of the internal jugular vein for assessment of vessel distensibilty in relation to stroke volume variation (SVV) measured by electrical cardiometry.

    Measured: 2 hours after the coronary artery bypass graft surgery

Secondary outcomes (1)
  1. Thoracic fluid content

    Evaluate the ability of thoracic fluid content (TFC) measured by electrical cardiometry to be an additive for the assessment of fluid responsiveness.

    Measured: 2 hours after the coronary artery bypass graft surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jul 2023
  2. Study start1 Mar 2023
  3. Primary completion1 Aug 2023
  4. Study completion30 Aug 2023

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05945303
Sponsor's protocol ID
Anas Ezzat Fathy
Status last verified
Oct 2023
First submitted
6 Jul 2023
Last updated
17 Oct 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Coronary Artery Bypass Grafting surgery in people with Coronary Bypass Stenosis and Coronary Artery Bypass Grafting Surgery, run by Egymedicalpedia 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 1 inclusion and 8 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 Oct 2023. 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?

Reliability of predicting fluid responsiveness (time frame: 2 hours after the coronary artery bypass graft surgery). 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 Oct 2023.

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