The aim of this clinical study is to determine, what the effect of RBC transfusion is on the microcirculation after cardiac surgery in the ICU, as compare to asanguineous colloid (Gelofusine®) infusion.
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The study parameters are: flow vs no flow of the RBC in the microcirculation,
capillary perfusion
oxygenation in the microcirculation
Secondary outcome
nvt.
Background summary
Cardiac surgery is normally associated with traumatic blood loss a low cardiac
output and the requirement for multiple red blood cell (RBC) transfusions.
Although circulatory insufficiency and blood loss are clear reasons to
administer RBC units, the effects on tissue oxygenation are less clear.
Parameters, able to unmask dysfunction of the microcirculation after RBC
transfusion,are actively searched.
Study objective
The aim of this clinical study is to determine, what the effect of RBC
transfusion is on the microcirculation after cardiac surgery in the ICU, as
compare to asanguineous colloid (Gelofusine®) infusion.
Study design
Twenty-four patients, who are administered to the Intensive Care Unit after
cardiac surgery and who receiving their first RBC transfusion or Gelofusine®
infusion, will be measured prior and after transfusion/infusion. With the use
of SDF, the flow of the RBC and the number of perfused capillaries will be
measured in the microcirculation. The data of the RBC transfusion and
Gelofusine® infusion, measured before and after the RBC transfusion or
Gelofusine® infusion, will be compared. The reflectance spectrophotmetry will
be used to measure the oxygenation of the microcirculation.
Bloodsamples will be used for global hemodynamics.
Study burden and risks
The capillary perfusion (flow and oxygenation) will be measured under the right
side of the tongue. The method is safe to be used on the Intensive Care Unit.
The method is non-invasive. Participating in the study contains no burden and
no risk for the subjects. The nature or duration of the treatment will not
change.
De Boelelaan 1007
1007 MB Amsterdam
Nederland
De Boelelaan 1007
1007 MB Amsterdam
Nederland
Listed location countries
Age
Inclusion criteria
Intensive care patients who receiving their first RBC transfusion or first infusion with Gelofusine® at the IC as part of routine clinical treatment.
Exclusion criteria
Younger than 18 or older than 80 years of age; medical, practical or ethical drawbacks or objections to participate.
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 | NL25250.029.08 |