The effect of Hydroxyethylstarch 6% 130/0.4 in a balanced electrolyte solution (Volulyte®) compared to gelatine (Geloplasma®) on microvascular reactivity and tissue oxygen saturation during haemodilution measured with near-infrared spectroscopy.

• Conditions: Patients undergoing elective coronary artery bypass grafting surgery.; MedDRA version: 14.1Level: LLTClassification code 10059489Term: HemodilutionSystem Organ Class: 100000004863; MedDRA version: 14.1Level: LLTClassification code 10068176Term: Coronary artery bypass graftSystem Organ Class: 100000004865; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2013-005209-30-BE
• Lead Sponsor: Ghent University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-12-10
• Last Update Posted: 28 August 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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 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 (Ranucci 2006).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified