Coronary Artery Disease Clinical Trial
Official title:
Comparison of Priming Constituents in Patients Undergoing CPB Assisted Cardiac Surgery: HES 130/0.4 or Albumin 5%
The purpose of the study is to determine which priming fluid is the safest for use for priming the heart-lung machine used during cardiopulmonary bypass for patients undergoing cardiac surgery. The fluids to be compared are albumin and voluven. A control group will receive only crystalloid.
Project title:
Comparison of priming constituents in patients undergoing CPB assisted cardiac surgery: 6%
HES 130/0.4 or Albumen 5%
Principal investigator:
Jo-Anne Marcoux M. Sc., CPC, CCP
Department:
Clinical Perfusion
Sub-investigators:
Victor Uppal B. Sc., CPC, CCP Taras Mycyk MD, FRCSC,
Research will be conducted at: the cardiac operating rooms of the Royal University Hospital,
and affiliated hospitals
Hypothesis It is hypothesized that the use of an artificial colloid (6% hydroxyethyl starch
130/0.4) (HES) as a priming constituent is more disruptive to the coagulation and renal
systems compared to the use of human derived albumen.
It is further hypothesized that patients who undergo cardiopulmonary bypass (CPB) with HES
130/0.4 as a priming constituent will demonstrate decreased creatinine clearance and
increased post-operative bleeding and transfusion requirements.
Academic validity Permissive hemodilution results when crystalloids and colloids are
substituted for blood as priming fluids in the cardiopulmonary bypass circuit. While there
are obvious benefits to decreasing autologous blood exposure to the patients undergoing CPB,
determining the most physiological substitution has not been conclusively resolved.
Historically, available HES had a greater molecular weight then the product currently in use
and was associated with detrimental adverse events when compared to saline as fluid
replacement therapy (5.3% vs. 2.8%, p < 0.001). (1) When albumin was compared to HES 450/0.7
and HES 200/0.05 for fluid management in adult CPB surgery, (18 trials of 970 patients) HES
increased transfusion of red blood cells by 28.4% (p = 0.027), increased the transfusion of
fresh-frozen plasma by 30.6% (p = 0.008) and increased the transfusion of platelets by 29.8%
(p = 0.027). HES 130/0.4 could not be compared to albumen in this same study because there
was insufficient data collected. However, no significant differences were found when
comparing transfusion requirements between HES 450/0.7, HES 200/0.05 and HES 130/0.4. (2)
Viscoelastic device analysis concluded that the administration of HES 130/0.4 in patients or
healthy volunteers resulted in a weaker and smaller clot. (3) Short-time infusions of HES
200/0.5 and HES 130/0.4 after cardiac surgery produced a temporary impairment of fibrin
formation and clot strength while human albumin had no effect. (4)
In regards to the association between HES and renal failure, on the one hand use of HES
130/0.4 as a priming fluid used in children undergoing CPB did not result in any negative
effects on renal function and was safe to use in the pediatric population. (5) On the other
hand, when used for resuscitative measures in 7000 randomly assigned patients admitted to
intensive care, though there was no difference in 90 day mortality between the group assigned
HES 130/0.4 and the group assigned saline, more patients assigned HES 130/0.4 required renal
replacement therapy. (1) When used immediately after CPB in a double-blind clinical trial
comparing 4% gelatin, Ringer's solution and HES 130/0.4, it was found that significantly
lower mean creatinine levels were found in the HES 130/0.4 group compared to the other two
groups. (6)
Our research is directed toward determining conclusively if HES 130/0.4 has a similar risk
profile to HES 450/0.7 and HES 200/0.05 when used as a priming constituent for the CPB
circuit. Additionally we will determine if an albumin/crystalloid prime is superior to a HES
130/0.4/crystalloid prime. A fully crystalloid prime control group will be included for a
controlled comparison.
Research design/Methods
The will be a randomized, control trial. Three groups of subjects will be studied:
1. Control group: Crystalloid prime
- 2 L crystalloid prime,
- 2.5 mL/kg Mannitol 20%,
- 1 ampoule of NaHCO-3 (50 mL),
- 10,000 iu heparin
2. Voluven (light?):
- HES 130/0.4 prime 500 mL
- balance of crystalloid
- 2.5 mL/kg Mannitol 20%,
- 1 ampoule of NaHCO-3 (50 mL),
- 10,000 iu heparin
3. Albumin:
- Human albumin 500 mL 5%
- balance of crystalloid
- 2.5 mL/kg Mannitol 20%,
- 1 ampoule of NaHCO-3 (50 mL),
- 10,000 iu heparin
Statistical Analysis We would like to have 7000 subjects included in this research project.
Study populations and outcomes for patients undergoing CPB assisted cardiac surgery are
extremely varied. An extremely large population size will be necessary to answer the research
question proposed as the priming differences in question result in very subtle outcome
differences.
All patients will undergo CPB assisted cardiac surgery. Blood samples will be drawn at
routine intervals from each subject. Blood will be sampled upon entering the operating room,
at the completion of surgery, and at 24 hours post-operatively.
The amount of blood drawn will not be above and beyond the usual tests and analyses related
to the care of all affected patients undergoing CPB assisted cardiac surgery.
a)
Inclusion criteria:
- greater than 50 years of age
- will be afflicted with co-morbidities associated with cardiac disease (increased
cholesterol, hypertension, smoking, diabetes, previous myocardial infarctions and
decreased ejection fraction)
Exclusion criteria:
- emergencies
- renal failure
- dialysis dependent
The cardiac center involved to date is:
RUH Saskatoon The goal is recruitment of all cardiac centers in western Canada.
Primary end-points: are postoperative bleeding and transfusion of autologous units of red
blood cells, frozen plasma and platelets.
Secondary end-points: Post-operative renal function parameter creatinine
Data collection will be ongoing. Interim analysis will be completed once half the patients
have been recruited with final statistical analysis to be conducted once data capture is
complete.
Potential Significance/Justification CPB assisted cardiac surgical outcomes have improved
tremendously since the first such procedure was done in 1953. Outcome improvements have
always come from small changes that were evidence based. This research project means to
determine the safest prime for a procedure, which occurs roughly 2,000,000/year throughout
the world. In regards to the cost of the study solutions in question, there is a $4.10
difference between the cost of 500 mL of HES 130/0.4 prime and 500 mL of 5% Albumin with HES
130/0.4 being more expensive.
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