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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-005209-30 | EudraCT Number |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Volulyte 6% | Experimental | - Volulyte 6% (HES 130/0.4 in an isotonic composition). In 1000 ml:
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| Geloplasma | Active Comparator | In 1000 ml:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Volulyte 6% | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Value of the StO2 recovery slope (recStO2) after postocclusive ischaemia. | Values are measured, using near-infrared spectroscopy. | after 3 minutes of postocclusive ischaemia |
| Measure | Description | Time Frame |
|---|---|---|
| Change of values of ScO2 during cardiopulmonary bypass (CPB ). | Continuously during cardiopulmonary bypass (= maximum 3 hours). | |
| Change of value of StO2 during cardiopulmonary bypass. | Continuously during cardiopulmonary bypass(= maximum 3 hours). |
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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.
Exclusion Criteria:
Exclusion criteria are an ejection fraction < 25%, a known allergy to HES, admission of HES or gelatines within the preceding 2 weeks, renal insufficiency (creatinine > 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
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| Name | Affiliation | Role |
|---|---|---|
| Annelies Moerman, MD, PhD | University Hospital, Ghent | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ghent University Hospital | Ghent | 9000 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28834795 | Derived | Vandenbulcke L, Lapage KG, Vanderstraeten KV, De Somer FM, De Hert SG, Moerman AT. Microvascular reactivity monitored with near-infrared spectroscopy is impaired after induction of anaesthesia in cardiac surgery patients: An observational study. Eur J Anaesthesiol. 2017 Oct;34(10):688-694. doi: 10.1097/EJA.0000000000000684. |
| Label | URL |
|---|---|
| Related Info | View source |
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| Geloplasma | Drug | 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. |
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| Change of blood gas analyses during cardiopulmonary bypass. | Continuously during cardiopulmonary bypass(= maximum 3 hours). |
| Change of haemodynamics during cardiopulmonary bypass. | 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). |