Patients undergoing elective coronary artery bypass grafting surgery. MedDRA version: 14.1 Level: LLT Classification code 10059489 Term: Hemodilution System Organ Class: 100000004863 MedDRA version: 14.1 Level: LLT Classification code 10068176 Term: Coronary artery bypass graft System Organ Class: 100000004865
Conditions
Interventions
Trade Name: Volulyte 6% oplossing voor infusie.
Product Name: Volulyte 6%
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Hydroxyethylstarch 6% 130/0.4
Other descriptive name: STARCH
Sponsors
Ghent University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Adult consenting patients scheduled for elective coronary artery bypass grafting surgery on moderately hypothermic (> 32°C) CPB without blood transfusion will be recruited. Age = 18 years. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: Exclusion criteria are an ejection fraction 2.0 mg/dl), significant hepatic disease (liver function tests > 3x upper limit of normal), history of cerebrovascular disease, significant carotid artery stenosis (> 60%), perioperative use of corticosteroids, and need for vasopressor or inotropic therapy before surgery. An expected haematocrit on CPB, calculated based on preoperative haematocrit, calculated blood volume and amount of cardioplegia, of < 23% is also considered an exclusion criterium (Ranucci 2006).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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. ;Secondary Objective: The microvascular reactivity and the effects on tissue (StO2) and cerebral (ScO2) oxygen saturation will be examined using near-infrared spectroscopy (NIRS). ;Primary end point(s): Endpoints are the effect of the priming solution on microvascular reactivity measured with NIRS. Oxygen consumption, recovery times and resaturation rate will be determined.;Timepoint(s) of evaluation of this end point: ScO2 and StO2 will be recorded continuously. Microvascular reactivity will be measured at the following time moments: awake (T0), after induction (T1), just after sternotomy (T2), just after heparinization (T3), 5 (T4) and 30 minutes after aortic cross-clamping (T5), 10 minutes after administration of protamin (T6), at skin closure (T7), and 2 hours after arrival at intensive care (T8). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): secondary parameters are continuous measurements of ScO2 and StO2 , blood gases (haemoglobin, arterial and venous oxygen content (CaO2 and CvO2), PavCO2 difference, pH, base excess, bicarbonate and lactate) at the different time moments, and continuous registration of haemodynamic parameters, urinary output and use of vasoactive medication during CPB. Postoperative creatinin at arrival on ICU will also be noted. Systemic oxygen delivery (DO2) and oxygen extraction ratio (OER) will be calculated according to standard formulae. Arterial (venous) oxygen content: Ca(v)O2 = 1.34 * Hb * Sa(v)O2 + 0.003 * Pa(v)O2, where Hb = haemoglobin concentration, Sa(v)O2 = arterial (venous) oxygen saturation, Pa(v)O2 = arterial (venous) partial pressure of oxygen. DO2 = Q * CaO2, where Q = pump flow. OER = (CaO2 - CvO2)/CaO2.;Timepoint(s) of evaluation of this end point: Until after patient arrival at ICU. | — |
Countries
Belgium
Contacts
Public ContactBimetra Clinics
Ghent University Hospital
Outcome results
None listed