Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT05945303 |
Other study ID # |
Anas Ezzat Fathy |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
March 1, 2023 |
Est. completion date |
August 30, 2023 |
Study information
Verified date |
October 2023 |
Source |
Egymedicalpedia |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical 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.
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.