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

Not Applicable

Completed

• Conditions: Microvascular Reactivity; Tissue Oxygen Saturation
• Interventions: Drug: Volulyte 6%; Drug: Geloplasma

• Registration Number: NCT02034682
• Lead Sponsor: University Hospital, Ghent

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-12-11
• Study Start: 2014-01
• Study First Submitted QC: 2014-01-10
• Study First Posted: 2014-01-13
• Primary Completion: 2014-08
• Status Verified: 2015-04
• Study Completion: 2015-04
• Last Update Submitted: 2015-04-23
• Last Update Posted: 2015-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Volulyte 6%	Volulyte 6%	- 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
Geloplasma	Geloplasma	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

Primary Outcome Measures

Name	Time	Method
Value of the StO2 recovery slope (recStO2) after postocclusive ischaemia.	after 3 minutes of postocclusive ischaemia	Values are measured, using near-infrared spectroscopy.

Secondary Outcome Measures

Name	Time	Method
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).
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).

Trial Locations

Locations (1)

Ghent University Hospital; 🇧🇪 Ghent, Belgium