Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT02560519 |
Other study ID # |
EPA1 |
Secondary ID |
|
Status |
Completed |
Phase |
Phase 4
|
First received |
|
Last updated |
|
Start date |
March 21, 2017 |
Est. completion date |
November 4, 2020 |
Study information
Verified date |
November 2020 |
Source |
Helsinki University Central Hospital |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
Colloid solutions are widely used for volume replacement therapy because of their high
oncotic pressure, which could reduce interstitial fluid shifting. Human albumin is the only
colloid solution of biologic origin with a molecular weight of 60 kDa. As the most abundant
plasma protein, it has physiological importance in the well-being of the endothelial
glycocalyx. Older studies in septic patients, however, did not show any benefit of albumin
over saline solution. Crystalloid solutions, such as Ringer's acetate, do not impair neither
renal function nor coagulation, but their volume expanding effect is questionable.
For several reasons (use of heart-lung machine, systemic inflammation, coagulation
disturbances), patients undergoing cardiac surgery need especially large amounts of fluids.
However, there are no large trials comparing albumin solutions to crystalloid solutions
cardiac surgery.
This double-blinded trial will randomize according to a power analysis 1250 cardiac surgery
patients (=625+625) at Meilahti hospital to use either 4% Albumin or Ringer's acetate
solutions for both priming of the heart-lung machine and perioperative volume replacement
therapy. The primary efficacy and safety endpoint of this study is the incidence of major
adverse events (MAE), defined as a composite endpoint of all-cause mortality, acute
myocardial infarction, acute heart failure or low output syndrome, resternotomy, stroke,
certain arrhythmias, major bleeding, infections compromising post-procedural rehabilitation,
acute kidney injury within 90 days postoperatively. The secondary outcomes are total number
of MAEs, major adverse cardiac events (MACE), perioperative fluid balance, blood product
transfusions, blood loss, acute kidney injury, days alive without mechanical
ventilation/outside ICU/at home in 90 days as well as 90-day mortality. Blood samples for
biochemical analyses will be collected at four perioperative time points.
This trial will provide data about efficacy and safety of 4% albumin in cardiac surgery
patients. The biochemical mechanisms of albumin will be assessed.
Description:
The use of cardiopulmonary bypass (CPB) between two study solutions: albumin solution with
the final concentration of 4% and Ringer's acetate solution. The trial consists of two phases
as follows. For each patient, one and the same study solution will used in both phases of the
trial according to randomization.
In the first phase of the trial, the study solution will be used for priming of the CPB
tubing. The CPB priming volume comprises only of the study solution. See the Blinding section
below for more details.
- Albumin group (trial group): A mixture of 20% (200 mg/mL) albumin solution (Albuman® 200
g/L, Sanquin, the Netherlands) with Ringer's acetate solution (see below) in the final
albumin concentration of 4%.
- Ringer group (conventional group): Ringer's acetate solution (Ringer-acetate®, Baxter;
pH 6.0, contents Na+ 131 mmol/L, Cl- 112 mmol/L, acetate 30 mmol/L) alone.
In the second phase of the trial, during surgery and the first 24 hours of ICU treatment,
study solution will be used up to 3200 mL for volume replacement therapy. Ringer's acetate
solution is used thereafter, i.e. if more than 3200 mL are needed for volume replacement
therapy during the second study phase. The volume replacement therapy is not protocolled but
will be based on the clinical decision.
Albumin group (trial group):4% (40 mg/mL) albumin(Albuman®, Sanquin, the Netherlands)
•Ringer group (conventional group): Ringer's acetate solution (Ringer-acetate®, Baxter; pH
6.0, contents Na+ 131 mmol/L, Cl- 112 mmol/L, acetate 30 mmol/L) The trial will end after the
first 24 hours of ICU treatment or when the patient leaves the ICU if the latter occurs
within the first postoperative 24 hours. After the study period, fluids are administered
according to the local clinical practice.
The use of blood products, excluding albumin, is not protocolled, but will be based on the
clinical decision.
For physiological basic need of fluid, Ringer's acetate solution will be given throughout the
study period, i.e. during surgery and postoperatively, as a background infusion of 0.5
ml/kg/h, rounded to the nearest multible of 10 ml.