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

Ghent University Hospital (UZ)

Status: Completed

Conditions: Tissue Oxygen Saturation; Microvascular Reactivity

Treatments: Drug: Volulyte 6%; Drug: Geloplasma

Study type: Interventional

Funder types: Other

Identifiers

NCT02034682

2013/1085

2013-005209-30 (EudraCT Number)

Details and patient eligibility

About

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).

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

Volulyte 6%

Experimental group

Description:

- Volulyte 6% (HES 130/0.4 in an isotonic composition). In 1000 ml: * Maize starch 60 gr. Molar substitution 0.38-0.45. 130000 Da * Na acetate trihydrate 4.63 gr * Sodium Chloride 6.02 gr * Potassium Chloride 0.3 gr * MgCl 0.3 gr * Sodium hydroxide-hydrochloric acid \& H2O

Treatment:

Drug: Volulyte 6%

Geloplasma

Active Comparator group

Description:

In 1000 ml: * Modified fluid gelatin 30 gr * Sodium Chloride 5.4 gr * Potassium Chloride 0.37 gr * MgCl 0.14 gr * Sodium lactate 3.36 gr

Treatment:

Drug: Geloplasma