Microvascular Reactivity, Tissue Oxygen Saturation
Conditions
Brief summary
The aim of this study is to compare 6% hydroxyethyl starch (HES) 130/0.4 in a balanced electrolyte solution (Volulyte®) with modified fluid gelatin (Geloplasma®) as the priming solution for the cardiopulmonary bypass (CPB) circuit. The microvascular reactivity and the effects on tissue (StO2) and cerebral (ScO2) oxygen saturation will be examined using near-infrared spectroscopy (NIRS).
Interventions
DRUGVolulyte 6%
During elective coronary artery bypass grafting surgery, patients need to be attached to a cardiopulmonary bypass circuit. Administration of Volulyte 6% to the cardiopulmonary bypass circuit.
DRUGGeloplasma
During elective coronary artery bypass grafting surgery, patients need to be attached to a cardiopulmonary bypass circuit. Administration of Geloplasma to the cardiopulmonary bypass circuit.
Sponsors
University Hospital, Ghent
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Adult consenting patients scheduled for elective coronary artery bypass grafting surgery on moderately hypothermic (\> 32°C) CPB without blood transfusion. Age ≥ 18 years.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Value of the StO2 recovery slope (recStO2) after postocclusive ischaemia. | after 3 minutes of postocclusive ischaemia | Values are measured, using near-infrared spectroscopy. |
Secondary
| Measure | Time frame |
|---|---|
| Change of value of StO2 during cardiopulmonary bypass. | Continuously during cardiopulmonary bypass(= maximum 3 hours). |
| Change of blood gas analyses during cardiopulmonary bypass. | Continuously during cardiopulmonary bypass(= maximum 3 hours). |
| Change of values of ScO2 during cardiopulmonary bypass (CPB ). | Continuously during cardiopulmonary bypass (= maximum 3 hours). |
| Urinary output during cardiopulmonary bypass. | At the end of cardiopulmonary bypass(= after maximum 3 hours).. |
| Use of vasoactive medication during cardiopulmonary bypass. | During complete cardiopulmonary bypass(= maximum 3 hours). |
| Change of haemodynamics during cardiopulmonary bypass. | Continuously during cardiopulmonary bypass(= maximum 3 hours). |
Countries
Belgium
Outcome results
None listed