These clinical pilot study examines whether there are differences between patients with ejection fraction (LVEF) > 30% who have undergone a CCABG or OPBH. We look at te myocardial damage, the use of inotropica, blood loss and blood…
Source
Brief title
Condition
- Cardiac therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
No registrations found.
Outcome measures
Primary outcome
Is there a difference in de myocardial damage between patient with an ejection
fraction > 30% who undergo CCABG or OPBH?
Is there a difference in the use of inotropica between patients with an
ejection fraction > 30% who undergo CCABG or OPBH?
Is there a difference in blood loss and use of blood (per-operatively until
dismiss IC) between patients with an ejection fraction > 30% who undergo CCABG
or OPBH?
Is there a difference in ventilation duration between patients with an ejection
fraction > 30% who undergo CCABG or OPBH?
Is thera a difference in the length of stay on the IC between patients with an
ejection fraction > 30% who undergo CCABG or OPBH?
Is there a difference in fluid balance at the OK between patients with an
ejection fraction > 30% who undergo CCABG or OPBH?
Is there a difference in the function of te left and rigth ventricle between
patients with an ejection fraction > 30% who undergo CCABG or OPBH?
Secondary outcome
Nothing
Background summary
Millions of people around the world have coronary sclerosis and needs bypass
surgery. Coronary artery bypass grafting (CABG) can be performed in different
ways.
In the hospital Medisch Centrum Leeuwarden we use two different techniques with
using a heart-lung machine: conventional Coronary Bypass Grafting (CCABG) and
by indication On Pump Beating Heart (OPBH).
Conventional Coronary Bypass Grafting - CCABG
Cardiopulmonary bypass (CPB) plays a major role for more than 50 years in the
heart surgery since the introduction by John h. Gibbon in 1953. CPB is for
decades the ' gold standard ' in heart surgery, studies have described the
negative effects of CPB on the area of inflammatory markers, coagulation,
micro-embolization, thermoregulation, acid-base balance and regional perfusion.
On Pump Beating Heart - OPBH
Another technique is OPBH. This is based on the use of CPB with a minimized
system, without the use of cardiac arrest.
The disadvantages of CCABG are reduced bij using a minimized CPB system in the
OPBH-technique. By luxation of the heart, the cardiac index is more than 2
l/min/m2. This reduces the preload of the heart, so positioning of the heart is
simple, despite the fact that the heart is not completely empty.
A number of studies show that OPBH is a safe and simple technique and is really
an alternative to CCABG in patients with a reduced heart function or by
patients with acute myocardial infarction. A significant reduction of damage to
the myocardium is described in using the OPBH-technique. However, other studies
show that the myocardial damage is more in OPBH.
In the literature most studies carried out in patients with OPBH around a
(strong) reduced heart function. Therefore the question arises: what is the
effect on patients with an ejection fractie > 30%. This pilot research involves
a clinical comparison of the degree of myocardial damage in two different
techniques: CCABG and OPBH.
Study objective
These clinical pilot study examines whether there are differences between
patients with ejection fraction (LVEF) > 30% who have undergone a CCABG or
OPBH. We look at te myocardial damage, the use of inotropica, blood loss and
blood consumption per-operatively yntil dismiss at IC, the ventilation
duration, stay on the IC, the fluid balance and the function of the left and
right ventricle.
Study design
In this pilot study, 40 patients who undergo an elective CABG randomised into
two groups:
-CCABG (20 patients)
-OPBH (20 patients)
Intervention
Group 1: undergoes a CABG-operation on conventional mode (with heart lung
machine and cardiac arrest)
Group 2: undergoes a CABG operation on beating heart, supported with minimized
heart lung machine
Study burden and risks
Both techniques are safe and are already applied in the hospital MCL.
Henri Dunantweg 2
LEEUWARDEN 8934AD
NL
Henri Dunantweg 2
LEEUWARDEN 8934AD
NL
Listed location countries
Age
Inclusion criteria
Elective CABG
Age between 18 and 85 years
Exclusion criteria
combined (valve)operation
Re-operation
Patients with ejection fraction <30%
Patients with severe calcified aorta, where the aortic clamp can not be placed
Patients with impaired renal function (Creatinine >150µmol/l and/or Urea 10,0 mmol/l)
Patients with existing chronic anaemia (Hb < 7,0 mmol/l)
Patient with known coagulation disorder
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL42811.099.13 |